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Product Description II

1. Variable Prefix Variable label Type Core Role Description e Collection date and time of an observation represented in ISO 8601 DMDTC yes Date Time of Collection Char perm Timing Variables chatactertormar AGEU no Age Units Char exp Qualifier Variables Units associated with AGE Age expressed in AGEU May be derived as RFSTDTC BRTH AGE no Age Num exp Qualifier Variables DTC but BRTHDTC may not be available in all cases due to sub ject privacy concerns BRTHDTC no Date Time of Birth Char perm Qualifier Variables Date time of birth of the subject in ISO 8601 character format Reference End Date time for the subject in ISO 8601 character Subject Reference End format Usually equivalent to the date time when subject was de RFENDTC no cad Char exp Qualifier Variables termi ned to have ended the trial and often equivalent to date time of last exposure to study treatment Required for all randomized su bjects null for screen failures or unassigned subjects Reference Start Date time for the subject in ISO 8601 character Subject Reference Start format Usually equivalent to date time when subject was first exp RFSTDTC no e Char exp Qualifier Variables osed to study treatment Required for all randomized subjects will be null for all subjects who did not meet the milestone the da te re quires such as screen failures or unassigned subjects SEX no Sex Char req Qualifier Variables Sex of the subject Race of the subject Sponsors sh
2. Delighted 1 5123 ha Delete house dust 3 601 kg 3 0 0010 5158 mg 2 1000 0 5157 Mild Rigidity detected without the activation maneuver but full range of motion is easily 2 5132 Mixed 4 5126 Moderate Rigidity detected without the activation maneuver full range of motion is achieved with 3 5133 Mostly Dissatisfied 5 5127 Mostly Satisfied 3 5125 never 1 5135 no 2 600 xl Add Cancel Save and back Save top Fig 28 View of the editing page for the group of labels for the answer options of the correspond ing item The sequence of the answer options plus the label text and the DB value saved in the data record can be defined With the aid of New LABEL it is possible to add a new label and specify a relevant DB value and conversion factor for unit groups and score calculation Alternatively one or more already existing individual labels can be selected and added via App The structure of the editing page is the same for both radiobutton types The DB values which are used must be unique within a group of labels A factor may also be additionally specified in the case of normal groups of labels for use in scores When set this is used to calculate the score instead of the database value This is particularly helpful when creating qualification tests Individual labels which are reused should only be subsequently changed with particular care as the chan
3. gt Rh Oinorativa Finnriffa an don loranarartarian Shunt und Conduit Operationen Fig 22 Example of the view of an ASCatalogGroup with catalog pop up excerpt Generic catalogs Further catalogs in a predefined CSV format see FormBuilder user manual Annex can addition ally be imported in the FormBuilder The description of the layers and columns can be edited on im port Catalog contents can no longer be edited however catalogs can be reloaded see below Generic catalogs can be used exactly like firmly implemented catalogs but remain restricted to the current customer Reloading catalogs Generic catalogs can be reloaded in the FormBuilder by uploading a new CSV file The previous version is then archived it can continue to be viewed and also initially continues to be used in the productive area see below The relevant current version is always used in the setup area so that this is also used in the pro ductive area the relevant project must be set to productive status again The relevant catalog ver sion which is used is displayed at the bottom right edge in the catalog question the relevant catalog version is also listed in the AuditTrail Catalogs are only loosely linked to the form the selected catalog contents are saved in the form as a text copy and not as a reference On reloading form data which have already been saved are not therefore automatically reloaded Consistency check
4. Age gt 45 AND Age lt 50 Hospital Hospital CN Hospital RU Language Score Language Score L Language Score M Language Score H Sex Sex M Sex F Parameter treatmentArmsName A B C Parameter allocatedPatients Table Age int Sex class java lang String Language Score class java lang String Hospit al class java lang String UPN int Treatment Arm class java lang String Tuple 47 M L CN 1 B Tuple 47 F H CN 2 A Tuple 41 M L CN 3 C Tuple 38 F H RU 4 B Tuple 45 M M CN 5 C Tuple 27 M L RU 6 A Tuple 46 M M CN 7 B Tuple 49 F M CN 8 C Tuple 45 F L CN 9 C Tuple 47 M M RU 544 B Tuple 31 F H CN 545 C Tuple 38 M L RU 546 C Tuple 47 F L CN 547 C Parameter newPatient Patient 548 Table Age int Sex class java lang String Language Score class java lang String Hospit al class java lang String Tuple 29 M M CN Parameter treatmentArmWeighting 1 07 4 0 5 0 Imbalance Scores 5 350000000000001 4 149999999999999 4 75 Considered TreatmentArms A B Cc Stratum Matrix 15 59 75 28 108 135 21 86 107 27 106 133 Chosen Treatment Arm B Example Extended stratified block without list secuTrial centre casenodes 1 cnid 606 centre Test randomgroup A test assigndate 2012 04 04 12 14 57 Etc GMT 2 cnid 607 centre Test randomgroup B test assigndate 2012 04 04 12 19 03 Etc GMT 3
5. FAMILY _COMPLETION tpxdocument form family projectid empty partial complete Summarizes the completion status of the formfamily defined by name and projectid As a result one of the given labels is returned Usable for casenode families or visit families displayed in only one visit FAMILY_DEC_COMPLETION tpxdocument form family projectid empty partial com plete finished Summarizes the completion status of the formfamily defined by name and projectid As a result one of the given labels is returned If the status DEC is set in all forms the finished label will be returned regardless of the stored completion status of the forms Usable for casenode families or visit families displayed in only one visit For the following review check functions these labels are possible for review type to check for a single or combined type of review A Review A B Review B A B FREEZE frozen by rule A FREEZE B FREEZE A B FREEZE LOCK manually frozen A LOCK B LOCK A B LOCK FREEZE LOCK A FREEZE LOCK B FREEZE LOCK A B FREEZE LOCK VISIT_REVIEW tpxdocument cvpid visitid review type none partial all Determines if the review status of all savable forms of the visit matches the given review type and returns the appropriate given label VISIT_FAMILY_REVIEW tpxdocument cvpid visitid family name review type none par
6. The width of the columns can be set in the upper area of the assistant In addition the table can be aligned either by manually dragging the table lines of the layout preview or by directly setting the pixel value or percentage in the upper entry field in the CSS Independent of the width division of the table as many additional user entries as necessary can be made in a separate CSS area This would for instance enable an alternating colour scheme for the table cells For information on the necessary entries please consult the relevant literature on CSS Note Layout Horizontal radio button matrix Benutzen Sie die Querbalken zur Gro enveranderung 1 Column I 2 Column Layout D Width 100 M table fg_type_iashorizrbmatrix fg_id vxfmqsrrld td col0 th nc th thfO width 50 table fg type_iashorizrbmatrix fg_id vxfmqsrrld td coll th nc th thf1 Layout CSS 9 width 25 table fg type _iashorizrbmatrix fg id vxfmqsrrld td col2 th nc th thf2 y width 25 table fg type iashorizrbmatrix fg id vxfmqsrrld background color 9999FF User defined layout CSS Fig 11 Layout assistant for the CSS of a radio button matrix in FormBuilder The layout assistant can be affected by your chosen browser If you are experiencing problems please try another browser Consistency check Non productive Can be changed to IASHeadline items are deleted ASHorizontalGroup ASStandardGroup I A
7. Value ranges For numerical items the value range into which the saved data are to be subdivided for evaluation has to be specified For a sensible evaluation at least two value ranges should be specified A plausibility check which warns you in the event of overlaps or gaps in the value range is available If desired this warning can be ignored by saving again Generation The data statistics can be optionally generated per project centre or country On generation per centre or country several statistics files are generated for each statistics definition In the AdminTool rights are still assigned via the assignment of roles to the statistics definition The display in the DataCapture is carried out depending on the current participant s role rights and assignment to the centres In the case of centre statistics only the statistics files for his centres are displayed to the participant In the case of country statistics assignment to a centre within the country is sufficient to be able to view the statistics file 7 1 Types general settings Messages can be generated in secuTrial from four different levels Project messages bundled not bundled Form messages Randomization messages Rule messages You can substitute the following placeholder in the subject lt CENTRE gt Name of current centre of the patient lt PAT ID gt Pat ID of the patient lt ADD ID gt Add ID of the pat
8. lt Oo YN 50 Ge lt D 2 ms m 2 co 2 Ws a ES Jon _ a oo o E D oO 5 5 oO _ cr oO v gt To Ex 30 S 3572 20 20 xogLS DI Z 85 Pals O 20 AL uo aadi Evo TLE gt azos x lt 1 oosa NA 1 cer oD X E 1 Horo Participient ptnid TPX subdocument gt atTPXsubdocument parentdig childdid parentdid childdid TPXcasenode cnid TPX document mnpdid 7 ptopdid AtT PX document mnpatdid D A mnpTPX sempre atmnpTPX p7 K2devadm K2mdadm devTPX TPX Visit forms Database schema user The primary key is displayed Project DB schema after the table name Customer DB prefix to 1 relation to N relation Renamed foreign keys are displayed at the relations TPX gt p gt Participient ptnid TPX subdocument atTPXsubdocument parentdig childdid parentdid childdid ptopdid TPX document mnpdid AtTPX document mnpatdid TPXcasenode cnid emnpT PX mnpTPX atmnpTPX 7 TPXcasevisitplan cvpid K2devadm K2mdadm devTPX TPX Adverse Event forms K2 Customer DB prefix TPX Project DB schema H i Centre ctrid Patient pid Participient ptnid gt to 1 relation to N relation H i Database schema user devTPX TPX The primary key is displayed after the table name Renamed foreign keys are displayed at the relations TPXcasenode cnid TPXadverseevent aeid TPXaefollowup fuid parentd
9. Avoidance of type inconsistencies and rule errors In this case a distinction is made between whether the question or the item is still available as a pure development version or whether it has already been set to productive status released The distinction is actually made at the layer of the question or item as these elements can also be subsequently added to a project which has already been set to productive status and can then be changed relatively freely until setting to productive status is next carried out The focus in this case is then on the avoidance of type inconsistencies If the question or the item has already been set to productive status data loss must be prevented under all circumstances Adaptation of the layout e g the switch from a layout beneath one another to a layout next to one another remains possible 2 3 Types The types are listed here in the sequence of the presumably most frequent use This is also the sequence in which they are offered in the FormBuilder IASStandardGroup As the name says this involves the standard type with which 50 to 90 of questions can be covered in the majority of projects To maintain the uniformity of the forms layout it is usually sensible to create all questions which do not expressly demand another type as an IASStandardGroup even if they only have one item 1 ASStandardGroup Comment First description with already fixed format Query Second description with po
10. Used to indicate when a question about the occurrence of a pre VSSTAT yes Completion Status Char perm Record Qualifier specified intervention was not answered Should be null or have a v alue of NOT DONE VSREASND yes Reason Not Done Char perm Record Qualifier Reason not done Used in conjunction with STAT when value is NOT DONE y ee a Anatomical location of an intervention such as an injection site VSLOC yes Location of Dose Administration Char perm Record Qualifier Example RIGHT ARM for an injection Short character value for TEST used as a column name when Short Name of Measurement converting a dataset from a vertical format to a horizontal format eTESTOD yes Test or Examination opar red Tope Th e short value can be up to 8 characters Examples PLAT SYS BP RRMIN EYEEXAM Name of Measurement Test or Synonym Qualifier of Long name For TESTCD Examples Platelet Systolic Blood SET Yes Examination Chae es TESTCD Pressure Summary Min RR Duration Eye Examination Position of Subject During Ob Pe Position of the subject during a measurement or examination Ex VSPOS yes servation nar Peri Recorra ualfer amples SUPINE STANDING SITTING Result or Finding in Original hs Result of the measurement or finding as originally received or col VSORRES yes Units Char exp Result Qualifier lected Examples 120 lt 1 POS VSORRESU yes Original Units Char exp Malo of Unit for ORRES Examples IN LB kg L Contains the result valu
11. 1010 07 2010 08 09 2010 07 2010 08 2010 09 2010 M Benin W Hamburg M M nchen W Berin W Hamburg M m nchen 01 09 2010 15 14 01 09 2010 15 14 Examples of the view of statistics as a normal bar chart and a 3D bar chart for three parameters Fig 69 Staggered bar chart 3D Patients according centres over time 3 Patients according centres over time 4 M Berin W Hamburg M m nchen E 3 a E 5 08 2010 09 2010 07 2010 08 2010 09 2010 W Berin W Hamburg M M nchen 01 09 2010 15 14 01 09 2010 15 14 Fig 70 Examples of the view of statistics as a parameters staggered bar chart and a 3D bar chart for three Horizontally staggered bar chart 3D Patients according centres over time 5 Patients according centres over time 6 07 2010 07 2010 08 2010 08 2010 09 2010 09 2010 i o 2 3 4 o a o 2 3 4 6 Fig 71 W Berin W Hamburg W M nchen 01 09 2010 15 14 bar chart for three parameters W Berin W Hamburg M M nchen 01 09 2010 15 14 Examples of the view of statistics as a normal horizontally staggered bar chart and a 3D Pie chart 3D Patients according centres 2 Patients according centres 3 M nchen 1 M nchen 1 Berlin 4 Berlin 4 01 09 2010 15 33 01 09 2010 15 33 Fig 72 Examples of the view of statistics as a normal pie chart and a 3D pie chart for two para meters 6 2 Evaluated information Recruit
12. 3 is only used in stratified situations This procedure uses different stratification factor levels and the stratification data of the patients instead of lists The intention behind this is to achieve balanced ratios in every stratification factor level which also leads to a balanced relation ship within the entire patient set A disadvantage of this procedure is that there is a possibility that the relationships cannot be achieved if there is only a small number of patients in a stratification factor level An additional disadvantage is that strictly speaking it is deterministic and you could cal culate the assignment of the next patient if you had knowledge of the patient data You can get round this predictability issue by additionally configuring the random element The difference between range minimization and variance minimization is the distance deviation It can be calculated how far away you are from a balanced situation if you put the patient in a certain arm The issue of how far away is a question of metrics Essentially the range method corres ponds with the 1 Norm the variance method with the 2 Norm The variance method is easier to cal culate in principle you do not need to look at the n 1 patients The differences should be very small The variance method tends to be slightly better Block randomization 4 5 6 requires lists to be defined beforehand with one or more blocks and can be used in stratified and unstratifi
13. Cancel Adopt gt CDISC ODM export annotations Fig 24 Layout assistant in FormBuilder Invisible items By explicitly positioning the items in the table structure with these components it is possible to create invisible items by not assigning a position within the table for these items These items are not displayed in the eCRF However these items will be treated as normal items both in the rule evaluation and when creating queries and comments In the implementation view the invis ible items will be listed below the displayed table in a separate section Layout Dummy The label of an Layout Dummy type item is now displayed in the complete column width of an ItemMatrix question component For all other item types with input elements the label is only displayed in 30 of the column width With an appropriate format of the dummy item HTML label e g lt div style width 100 back ground color blue gt my headline lt div gt and a display over the complete table width span over all included columns the item can be used as a replacement for a subheading in an ltemMatrix ques tion Consistency check Non productive ASHorizontalGroup ASStandardGroup lASAlternateStandardGroup Productive ASHorizontalGroup ASStandardGroup lASAlternateStandardGroup A small number of item types which are specifically linked to a question component type cannot be created in an ASItemMatrix These include the
14. QD BID TID QID CO Comments Domain Special Purpose Variable Prefix Variable label Type Core Role Description The text of the comment Text over 200 characters can be added E a omment Sua wed Tope to additional columns COVAL1 COVALn DA Drug Accountability Findings General Observation Class Variable ae Variable label Type Core Role Description DACAT yes Category Char perm Grouping Qualifier Used to define a category of topic variable values DASCAT yes Subcategory Char perm Grouping Qualifier Used to define a further categorization of CAT values Used to indicate when a question about the occurrence of a pre DASTAT yes Completion Status Char perm Record Qualifier specified intervention was not answered Should be null or have a v alue of NOT DONE DAREASND yes Reason Not Done Char perm Record Qualifier Reason not done Used in conjunction with STAT when value is NOT DONE Short character value for TEST used as a column name when Short Name of Measurement converting a dataset from a vertical format to a horizontal format DATESTED yes Test or Examination Char req Topic Th e short value can be up to 8 characters Examples PLAT SYS BP RRMIN EYEEXAM Name of Measurement Test Synonym Qualifier of Long name For TESTCD Examples Platelet Systolic Blood PATESTI Yes or Examination enak Med TESTCD Pressure Summary Min RR Duration Eye Examination Result or Findi
15. converting a dataset from a vertical format to a horizontal format PIES Drives Test or Examination Enar 1169 Lople Th e short value can be up to 8 characters Examples PLAT SYS BP RRMIN EYEEXAM PPREASND yes Reason Not Done Char perm Record Qualifier ees Bones VSSA Ineo mine lOs Used to indicate when a question about the occurrence of a pre PPSTAT yes Completion Status Char perm Record Qualifier specified intervention was not answered Should be null or have a v alue of NOT DONE Numeric Result Finding in Used for continuous or numeric results or findings in standard PPSTRESN yes Standard Units 9 Num exp Result Qualifier format copied in numeric format from STRESC STRESN should sto re all numeric test results or findings PPSCAT yes Subcategory Char perm Grouping Qualifier Used to define a further categorization of CAT values Variable Qualifier of Standardized units used for STRESC and STRESN Example PPSTRESU yes Standard Units Char exp STRESC and STRESN mol L ee n Collection date and time of an observation represented in ISO 8601 PPDTC yes Date Time of Collection Char perm Timing Variables charactertormat QS Questionnaires Findings General Observation Class Variable Prefix Variable label Type Core Role Description QSCAT yes Category Char req Grouping Qualifier Used to define a category of topic variable values Evaluation interval associated with an observation such as a find ing TESTCD represented in ISO 8601 chara
16. message Up to date status The validation report lists the validation messages saved in the database which were valid when the form was saved If the data validation has changed since then either because of changes to the rule definition in a form or because a value has been changed in another form which was used as a value threshold in a rule check the validation report may not display the current data validation status If relevant changes are made to the rule definitions it is advisable to update the validation re port via a mass action revalidation of the project Note An validation report set up after the update on secuTrial version 4 4 will not display any content be cause validation messages have not yet been saved In existing studies the revalidation function can be used to save the validation messages for the first time Two types of information can basically be evaluated Information on the number of patients and information on the number of patients per answer value in a specific item The type of portrayal depends on the number of portrayed parameters there are graphics for two or three parameters which are dependent on each other whereby the type of graphic may in turn be two or three dimensional Non saved forms or no answer in the evaluated field are handled identically The data statistics are optionally created for all created patients patients per centre or patients per country This can be selected under Gen
17. tial all Determines if the review status of all savable forms of the visit and formfamily matches the giv en review type and returns the appropriate given label FAMILY_REVIEW tpxdocument family name projectid review type none partial all Determines if the review status of all savable forms of the formfamily matches the given review type and returns the appropriate given label Instead of a DB function sub queries or CASE WHEN constructions can also be inserted 5 2 Free SQL In addition to the SQL report there is an additional report type Free SQL With this report type the Select statement can be freely formulated in a large text field The statement must begin with a SE LECT and must not end with a semi colon Outer brackets will be ignored when checking When displaying this report manual entered linewraps will remain Lines longer then 100 characters print preview 80 will be wrapped automatically at the last blank included Furthermore the text must not include a number of fixed terms as commands text in single quota tion marks will be ignored The forbidden commands are listed in the help text For the statement to also be displayed in DataCapture a description must additionally be entered for every column this is optional for columns which are not to be displayed In the description the column name or alias if set from the statement must be used as the variable name Apart from this t
18. 56 O O 57 Form ntal SaO ta e asas 57 Formi prereg isteS aia 57 AETR oa UOT a EEE EEE E E E E A E ES catenins 58 E NS e e EE E E A E ig E EE A EE E A A T 58 33 Individual description tii di 58 A a TON 58 Show treatMent Meco a A E Dd 59 Freeze casenode Mii il A E A A ds 59 Delete casenode ifiran eenean a ia Eae aaa EN e dad 59 Display formi if reerde A E e EEEE dada 59 Take date from iii A aka aie ae aE 60 Calculate date time interval from oooooocccnnnnnnccconnononcnnnnnnnnnnnnnnnnnnnnnnnnnn nono nnnnnnnnnnnnnnnnnannninncnnns 60 Confirm IN PUES aria A AAA A ees 61 Ignore for completion StatUS ooocccononccoccnononanccccconnnnncnncnnnnnnnnnccnnnnn cnn nn nnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 61 Ignore for completion status Io ooonninninococccccononncccccnncnnnnnnnnnonnnnnncnnnonnnnnnnnnnnnnnnnn nn nn nnnncnnnnnnnnnn 61 INDULIMPOSSIDIS if airiai nae Ad a A dt tb 61 DUE required cc A ie aden 62 Inp t required rosita AE 62 Input required or ignore completion status I oooooonnnnicccinnnonccccononcnccccocnnnnnnnnannnonnnnnncnnnnnnnaninns 62 Input Only possible citrico tt tabateetasabsapcapedcidsaytapeba nye cl deel ater 63 Free TollOwinG TOMMS Fernets a devsenshanendes bb aaa 63 Freeze folowing Torms estaciona tallada 64 Free single fOr T a ita aaar ld a a a a a aa iar 64 FreeZe singe fommi AE i e a a a sania A e aaa a Sa id dy aaa aaa 65 Form input not PoOssible ih a eaaa e a a dealer aei 65 Form input ony POSS D E f aiar aa tated a e
19. 9 View after the user has clicked onto More twice For every IAS RepetitionGroup you can also define whether further repetitions are possible after DEC If this option is selected and on condition that the DEC status has been set in the form the DEC status cannot be revoked the form and the patient have not been frozen the participant has the editing rights to make changes the More button will be displayed again in DataCapture and the participant can create more repeti tions for the repetition group Consistency check Non productive Can be changed to all types Productive Can no longer be changed No items can be created IASHorizRBMatrix The radiobutton matrices offer a practical method for accommodating several questions with the same answer options in a tight space The prerequisite for use is therefore That this involves option questions see Horizontal radiobutton That at least two questions with the same answer options are available That the layout in a single question i e with a common help is legitimate In an IASHorizRBMatrix the questions are arranged horizontally in lines and the answers vertically in columns They are suitable for question groups with short answer options and longer question texts The standard example is the many items with yes no or yes no not applicable as the answer Please read each item and circle the number that best describes how sat
20. A OEE A ITiS 103 LO RUS MESSAGES nira a A O a E A 103 ANEX ce a a o es a ie e a 104 8 1 secuTrial database structure Essential project tables ee eeeeeeeeeeeeeeeeeeeteeeeeeeeeeeeeees 104 OPI CALs NT 105 Casenode TONMNS sc a a Sa tind tie a E S E ANA 106 ISIC TORING ont saz Ae here sate Rec E a ra esta teats 107 Adverse Event form vicsassi2eiics a AA aa idad 108 8 2 Available SDTM variables cecccceceeeeeeeeeeeeeeeeececencaaeeeeeceeeeeeeeeeeeeeseeeeaaaceeeeeeeseaaaeeees 110 AE Adverse Events Events General Observation Class ccccccceceeneeeeeteeenneeeeeteeeeeeeeees 110 CE Clinical Events Events General Observation ClaSs ccccccccecsessceeeeeeeeeeeeeeeeeeeeeees 112 CM Concomitant Medications Interventions General Observation ClasSS oo ococccccccc 113 CO Comments Domain Special PurpoSe 2 ccccecceceeeeeeeeeeeeeeeeeceeeeeeeeeeeaaeeeeeeeeenaas 114 DA Drug Accountability Findings General Observation ClaSS ooooconnnonccinnncccccccccccnccnninnns 115 DM Demographic Special PUrpOSE ooooooooccccccccccccccconocononononnnncnnnnnnnnnnnncnnnnnnnnnnnnnnnnnncnnnnnnnnnn 116 DS Disposition Events General Observation Class cccceececeeeeeeeeeeeeeeeeeeeeeeeeeeeeeenaes 116 EG ECG Test Results Findings General Observation Class ccccccceccceeeeeeeeeeeeeeeeees 117 EX Exposure Interventions General Observation Class cccceeeeeeeeeeee
21. AECAT yes Category Char perm Grouping Qualifier Used to define a category of topic variable values CE Clinical Events Events General Observation Class Variable Prefix Variable label Type Core Role Description Standardized or dictionary derived name of the topic variable Standardized Treatment TRT or the modified topic variable MODIFY if applicable Eq CEDECOD yes Name Re eats Char perm Synonym Qualifier of TRT uivalent to the generic drug name in WHO Drug or a term in SNOMED ICD9 or other published or sponsor defined dictionar ies End Relative to Reference aan A Identifies the end of the observation as being before or after the CEENREPT yes Time Point Char pem Miming variables sponsor defined reference time point defined by variable ENTP T Description or date time in ISO 8601 character format of the spon CESTTPT yes Start Reference Time Point Char perm Timing Variables sor defined reference point referred to by STRTPT Examples 2 003 12 15 or VISIT 1 Start Relative to Reference sat Identifies the start of the observation as being before or after the GESTRIBE Nes Time Point CRAN Pam Timing Variables sponsor defined reference time point defined by variable ST TPT Identifies the end of the observation as being before during or after End Relative to Reference the sponsor defined reference period The sponsor defined r efer CEENRF YeS Period Char perm Timing Variables ence period is a continuous period of time d
22. Char perm Variable Qualifier of TRT aoa medication or treatment often obtained from a coding SUREASND yes Reason Not Done Char perm Record Qualifier Reason not done Used in conjunction with STAT when value is NOT DONE Used to record whether a pre specified intervention occurred when SUOCCUR yes Occurrence Char perm Record Qualifier information about the occurrence of a specific intervention is s oli cited SUSCAT yes Subcategory Char perm Grouping Qualifier Used to define a further categorization of CAT values Standardized or dictionary derived name of the topic variable TRT or the modified topic variable MODIFY if applicable Eq SUDECOD yes Standardized Treatment Name Char perm Synonym Qualifier of TRT uivalent to the generic drug name in WHO Drug or a term in SNOMED ICDS9 or other published or sponsor defined dictionar ies SUDOSTOT yes Total Daily Dose Num perm Record Qualifier Total daily dose of TRT using the units in DOSU Used when dosing is collected as Total Daily Dose VS Vital Signs Findings General Observation Class Variable Prefix Variable label Type Core Role Description VSCAT yes Category Char perm Grouping Qualifier Used to define a category of topic variable values Date Time of Reference Time ran Date time for a fixed reference time point defined by TPTREF in VSRFTDTC yes Point Char perm Timing Variables ISO 8601 character format
23. M Queries M Comments M Patient status Y Centre A 0 No patients included Y Centre B 7 PatlD 1 visit 2 visit 3 visit Patient status Adverse Event Images aa j jz89 Fig 64 Example of the view of an icon report Here the status information is summarised in the same icons as those displayed in the patient form overview The display of the various status components can be selected and deselected via the title bar 5 8 Image forms This report type lists all image forms created for each patient with a display of the thumbnail which has been configured Information on the form name assignment created when and by whom is displayed as a tool tip 7 31 08 2010 20 19 CEST Close T ant Dipl biol Susanne Schneider a secu ria e Study 1 31 08 2010 20 17 04 CEST Print Image overview t f lt All gt z lt All gt z Y Centre A 0 No patients included Y Centre B 7 ick371 A 1 IP Image form jqj789 0 pxe146 Image form Image form Image form Image form xel012 0 xkx764 1 Image form xyx219 B 0 zpu285 0 Fig 65 Example of the view of an image form report All forms are portrayed as thumbnails in a horizontal row via the image items defined in the form The displayed name and the colours of the rows can be configured for this report 5 9 Validation Error report The report type Validation or error report can be created as another report type The report is
24. Non productive Can no longer be changed to other types as soon as a catalog field is created the catalog can still be changed On changing the selected catalog all previously created cata log fields are deleted Productive Can no longer be changed Only catalog fields can be created IASItemMatrix The lASltemMatrix provides a greater freedom in designing the eCRF layouts It allows you to or ganize different item types in one table layout Individual items can also be displayed across several columns or rows A common heading can be displayed before each row and above each column Table component new Comment Headline of column 1 Headline of column 2 Query y C yes Headline of row 1 Radio button C no Headline of row 2 Check box This is a simple selection option JT Fig 23 Example of a table question component The items can be arranged in FormBuilder using the table layout assistant which features intuitive drag and drop functions The initially separately created items of the question are dragged into the corresponding positions in the table It is possible to extend the table or to merge columns and rows by selecting the table elements and moving the lines of the table The online help instructions ex plain how to use the assistant Overview layout E Radio button Headline of r without HTML lt rb1 gt Check box Headline of r cobs Unused items Number field without HTML lt z gt
25. Query daily sometimes rarely never Alcohol E E E C Cigarettes E E C E Illegal drugs E E E E Fig 13 Example of the view of an IASCheckboxMatrix Despite the same appearance there is a significant difference in logic versus the radiobutton matrices As not only one answer is possible each check box i e each answer options is regarded as one question with two answer options NULL and one i e Not checked or Checked This makes creation very laborious and a high number of database fields are required Rules additionally have to be individually defined for each check box Included Items 12 Displayed order shown no Item Displayed order Answer Type Database column Delete from database gt fo Alcohol 1 daily CheckBox r1s1 Delete gt fo po Alcohol 2 sometimes CheckBox r1s2 Delete gt fo po e Alcohol 3 rarely CheckBox r1s3 Delete gt fa poo Alcohol 4 never CheckBox r1s4 Delete gt ao 7 Cigarettes 1 daily CheckBox 12s1 Delete gt feo po gt Cigarettes 2 sometimes CheckBox 1252 Delete gt fro po Cigarettes 3 rarely CheckBox 12s3 Delete gt fa Cigarettes 4 never CheckBox r2s4 Delete gt fan z Illegal drugs 1 daily CheckBox 13s1 Delete gt fioo i Illegal drugs 2 sometimes CheckBox r3s2 Delete gt mo po Illegal drugs 3 rarely CheckBox 13s3 Delete gt fiz0 7 Illegal drugs 4 never CheckBox 13s4 Delete New item Fig 14 Overview of the items of the ASCheckboxMatrix in the FormBuilder
26. Result of the measurement or finding as originally received or col EGORRES yes Units Char exp Result Qualifier lected Examples 120 lt 1 POS Date Time of Reference Time Es Date time for a fixed reference time point defined by TPTREF in EGRFTDTC yes Point Char perm Timing Variables ISO 8601 character format Name of Measurement Test Synonym Qualifier of Long name For TESTCD Examples Platelet Systolic Blood POTE YES lor Examination opar eg TESTCD Pressure Summary Min RR Duration Eye Examination Short character value for TEST used as a column name when Short Name of Measurement converting a dataset from a vertical format to a horizontal format POTE STORIES Test or Examination chak ied Topig Th e short value can be up to 8 characters Examples PLAT SYSBP RRMIN EYEEXAM EGLOC yes Location of Dose Administra Char perm Record Qualifier Anatomical location of an intervention such as an injection site tion Example RIGHT ARM for an injection Variable Prefix Variable label Type Core Role Description EGREASND yes Reason Not Done Char perm Record Qualifier Reason not done Used in conjunction with STAT when value is NOT DONE Used to indicate when a question about the occurrence of a pre EGSTAT yes Completion Status Char perm Record Qualifier specified intervention was not answered Should be null or have a v alue of NO
27. also problematic Under certain circumstances it may be impossible for the participant to see that these data have not yet been saved although they are displayed If the value in the template is changed after the value has been adopted and saved the subsequent data will not be changed automatically Form prerequisites Form input not possible if Form input only possible if These rules have no effects in the form in which they are created They are not checked during either initialisation or saving 3 3 However these rules can be selected as a prerequisite in another form On initialisation of this other form the rules in the preceding form data are then checked and if necessary the form to be opened is not released for editing The rule error message is then displayed as a prerequisite message above the form If such a rule is to be created as the prerequisite for a form in another visit it must be noted when creating the condition that the compare with value cannot be selected most of the times from the Current visit as the rule is evaluated from another visit when checking the prerequisite Visit condition Show treatment arm if This rule has no effect in the form in which it was created It is not checked upon initialisation or when saving However this rule can be selected as a condition for a treatment arm of the visit plan Each rule can be selected as a condition for only one treatment arm If a
28. are described here in alphabetical sequence To prevent application errors in the productive area the rules and their effects should be extensively tested in the secuTrial test area Consistency check In contrast to the upper layers of the form descriptions rules can also always be deleted after setting to productive status as this does not result in any data loss As the conversion of rules leads to numerous complications this is generally prohibited by the consistency check In this case the rule must simply be deleted and recreated in the desired form Otherwise rules also affect the deletion capability of form elements which may lie in completely different project setup locations particularly when form items are referenced within them If e g the Entry form contains the question Did XY participate in the examination and a later Laboratory form contains the question XY examination results it should only be possible to com plete this if the first question was answered Yes This condition can be simply created using the set of rules The rule Input only possible if is created with the condition item Entry participation xy Yes for the corresponding items in the Laboratory form In turn this reference then means that both the item containing Did XY participate in the examination and the entire form can no longer be deleted In the FormBuilder this restriction is displayed with the note Not deletable be c
29. be created in IASStandardGroup lASAlternateStandardGroup lASHorizontalGroup IAS UnitGroup automatic creation without past point digits and ASHorizontalUnitGroup automatic creation without past point digits Non productive Cannot be changed in IASUnitGroup or ASHorizontalUnitGroup Productive Can only be changed to a number which has at least as many or more pre and post decimal places as in the productive version Textfield The text field type is used for free text data designations etc The size of the field and the maximum number of characters are coded via text field x with x number of characters In contrast to the TextArea the text field is always one line At present x 1 10 15 20 22 25 30 35 40 50 60 70 80 or 100 are possible 5 Query Birth place 4 Other comments Fig 39 View of a TextField20 above and TextField 60 below Format check The input is restricted to the maximum number of defined characters No other check regarding the type of input is carried out Consistency check Can be created in lASStandardGroup lASAlternateStandardGroup lASHorizontalGroup ASUnitGroup and ASHorizontalUnitGroup Productive Can be changed to TextArea or text field in which the total text length is greater than or equal to the text length of the productive version TextArea This field is used for free text data comment explanations etc The size of the field and
30. biol Susanne Schneider Project Study 1 24 08 2010 17 57 29 CEST Centre Centre B Country Germany Pat ID pxe146 1 visit 02 01 2000 CET Form family Base Examination Form Personal Data Fig 2 Page structure of an eCRF in DataCapture The secuTrial eCRF pages always have the same structure consisting of the header 1 main part 2 and footer 3 Formal data on the participant patient and project plus menu buttons for general navigation are displayed in the header The footer contains the buttons for saving or cancelling the form plus a summary of the header data underneath The main part encompasses the form fields in which the data are recorded The FormEngine defines the structure of the centre part with its fields whilst it has no influence on the window structure with the header and footer The centre part is therefore the form in the stricter sense which again has a typical structure 1 3 Form structure A secuTrial form has typical elements some of which are present in each form or which can be used optionally The way in which these elements appear in the DataCapture and how they are designated in the FormBuilder nomenclature is described here A good knowledge of these standard elements and their positioning plus the related field in the FormBuilder is important in order to 1 Compile the data records sensibly and 2 Fill in the correct fields on creation in the FormBuilder The elements can be refle
31. catalog in german Main and secondary diagnosis congenital Haupt und Nebendiagnose angeboren Secondary diagnosis acquired Nebendiagnose erworben Extra diagnosis Extra Diagnose Operation Intervention Operation Intervention Intervention Intervention Symptom or risk factor Symptom oder Risikofaktor Complication Komplikation Measure MaRnahme HFN diagnosis HFN Diagnose Catalog ASCatalogGroup Comment Operationsgruppe Query FormBuilder 3 4 0 8 Build 467 Catalog A5 Mozilla Firefox 01 xj Operation https buildserver ias local apps WebObjects ST34 setup FormBuilder woa 1 wo SeQZMvc3bd5WYrnSMSibAw_0IA5 47 0 0 7 7 7 ICD 10 Print Close EPCC code plo do dea ICD 10 additional arch for Search Reset Search in M ope u M Operationiintervention M EPCC code Mico 10 M iCD 10 additiona Dr Operationsgruppe Operation Intervention EPCC ICD 10 ICD 10 code additional D Art der Operation gt Operationen an den grossen Yenen gt Operationen der Worh fe gt Operationen an den Av Klappen und bei Av Septumdefekt gt Operationen an den Ventrikeln und arn Ventrikelseptum gt Operationen an den VA Klappen und an den grossen Arterien Operationen bei FALLOT scher Tetralogie Double Outlet Ventricle und Transposition Operationen bei funktionell univentrikularem Herz
32. comments for each patient 8 2 Available SDTM variables AE Adverse Events Events General Observation Class Variable Prefix Variable label Type Core Role Description Standardized or dictionary derived name of the topic variable TRT or the modified topic variable MODIFY if applicable Eq AEDECOD yes ie TEAMIEN Char req Synonym Qualifier of TRT uivalent to the generic drug name in WHO Drug or a term in SNOMED ICD9 or other published or sponsor defined dictionar ies Description or date time in ISO 8601 character format of the spon AEENTPT yes End Reference Time Point Char perm Timing Variables sor defined reference point referred to by ENRTPT Examples 2 003 12 25 or VISIT 2 AESCAT yes Subcategory Char perm Grouping Qualifier Used to define a further categorization of CAT values AEPRESP yes Pre specified Char perm Record Qualifier Used when a specific intervention is pre specified on a CRF Val ues should be Y or null a Synonym Qualifier of TRT If the value for TRT TERM or ORRES is modified for coding PEMOPIEN Aves Mode NANE Char perm TERM or ORRES purposes then the modified text is placed here Location of Dose Adminis De Anatomical location of an intervention such as an injection site Ex PELOG yes tration Ghar pame Recor GUANG ample RIGHT ARM for an injection AETERM yes Reported Term Char req Topic Topic variable for an event observation
33. corresponding image file Comment A BE Upload an image Fig 5 Example of an IASAlternateStandardGroup with an image item Consistency check Non productive Can be changed to IASUnitGroup or IASHorizontalUnitGroup as long as there are no items on saving the two mandatory fields number field and unit list are then created automatically Can be changed to IASHorizontalGroup or IASStandardGroup as long as it only contains number field text field text area check box radiobutton pop up or score field type items IASAlternateStandardGroup with only one radiobutton or check box can be changed to a RB matrix or check box matrix IASAlternateStandardGroup with lookup fields only not with extendable lookup fields can be changed to an IASMultipleSelection IASCombinedSelection or ASHorizontalCombinedSelection Productive Can be changed to IASHorizontalGroup lASStandardGroup Except catalog fields all item types can be created IASHeadline Serves to portray an intermediate header This can be used to subdivide forms into clearly arranged sections or simulate a further hierarchical layer As mentioned above it is important to give early consideration to the implementation of a form layout with the options offered by secuTrial The breakdown with ASHeadlines may prove helpful in this case The ASHeadline does not contain any items or description texts The next layer is not therefore displayed if IASHeadline has been sel
34. for editing The middle part offers the option of inputting general data The lower part shows the status selected for display and on the outer right the pre view of the style sheets Completion status The completion statuses of all forms which can be saved are added here A visit is only completely filled when all forms which can be saved are completely filled see Fig 60 Query If at least one single open query is created on all of a visit s forms this results in the status Open query for the entire visit If all queries in all forms have been answered the entire visit has the status Answered query Accordingly all queries in all forms must be closed to obtain the overall status Closed query Comments g One single comment on any form sets the visit status to Comment in this case Source Data Verification SDV The SDV states of all forms which can be saved are added here It can be checked for the following summary SDV status values not done all status are not done in process at min one status is not done not necessary all status are not necessary verified at min one status is verified no status is not done or verified with problems verified with problems at min one status is verified with problems no status is not done 5 6 Query details g Query details shows an individual list of all queries which have been created A fi
35. for fields without entries The following types of comparison values are possible Boolean literal TRUE FALSE The two Boolean Literals correspond with the true or false condition Integer Literal 1 5 12340 Whole numbers without further entries are calculated as integer lit erals Double Literal 1 0 3 1415 1e 35 2 3e6 Numbers with a decimal point or exponential repres entation in scientific notation are calculated as double literals String Literal some text a label Text in double or single quotation marks is calculated as a string literal As comparative operators the following entries are possible X y X y equality Tests the equality of x and y x l y x lt gt y inequality Tests the inequality of x and y x gt y greater than Tests if x is greater than y x gt y greater than or equal to Tests if x is greater than or equal to y x lt y less than Tests if x is less than y x lt y less than or equal to Tests if x is less than or equal to y x AND y x amp amp y and Tests x and y equally true x OR y x y or Tests for x or y equally true or both NOT x x not Tests for the negation of x not equal to true x XOR y exclusive or Test for x or y equal to true not both IF test THEN x ELSE y if then else Evaluates the expression test if this is true then the ex pression x is evaluated otherwise the expression y parenthe
36. for the Hide rule has to be specified in inverse logic Values in hidden items will be deleted set to NULL Rules on hidden items have no effect Usage For visit forms casenode forms adverse event forms image forms sub forms within a sub form only items of the own sub form can be used as a rule condition Show treatment arm if Can be applied to Condition Type Check Form status Casenode status Error message Effect Usage Freeze casenode if Can be applied to Condition Type Check Form status Casenode status Error message Effect Usage Delete casenode if Can be applied to Condition Type Check Form status Casenode status Error message Effect Usage Display form if All item components except DB Dummy and Layout Dummy Depending on field type Action Create new visits No effect No effect No Creating visits for the assigned treatment arm is enabled For visit forms All item components except DB Dummy and Layout Dummy Depending on field type Action Saving revalidation No effect Yes mnpcs3 is set to 1 No The status of the agpatient and casenode is set to sysfreeze Further editing in this project is no longer possible For casenode forms in genuine part projects All item components except DB Dummy and Layout Dummy Depending on field type Action Saving revalidation No effect Yes mnpcss5 is set to
37. from Fig 13 On creation of the ASCheckboxMatrix each check box must be created as an individual item including rules The same question text must be specified as the question text for all check boxes within a row In the second step each check box is then assigned with the corresponding label text as the column heading All check boxes standing in the same column in a matrix must have the same same ID label text The sequence of the rows arises from the sequence created for the items whereby the item in a row which is used to determine the sequence of the questions is taken by random The sequence of the columns arises from the sequence which is specified in the labels The evaluated column for the answer sequence is also rather random in this case The data should therefore be set identically in the rows and columns and the portrayal should be checked in the preview Consistency check Non productive Can be changed to ASHeadline items are deleted Productive Can no longer be changed Only check boxes can be created IASMultipleSelection Special case of several hierarchically linked lookup tables not extendable which mutually influence each other On selection of an entry in one of the lists the form is reloaded and the upper and lower lists are displayed filtered with adequate contents ASMultipleSelection Comment Query Pet Breed Colour lt Please choose gt _y lt Please choose gt y
38. lt Please choose gt v Icelandic Fig 15 Example of the view of an ASMultipleSelection consisting of three lookup tables Without selection in the upper left lookup table all elements are pre loaded in the lower lookup table see Fig 18 ASMultipleSelection Comment Query Pet Breed Colour Cat x Siamese Y Fig 16 Following selection in the middle lookup table the corresponding entry is selected in the upper table left The possible lower values are filtered in the lower table right The different lookup tables must first have been created in the project and must accordingly be hierarchically linked On compilation of the IASMultipleSelection only the lookup tables possible from the hierarchy are also offered for the further items following the selection of the first lookup table Normally the items are distributed evenly according to their number over the width of the page with 3 items each item therefore takes up 1 3 of the width of the page A Flexible column width can be configured instead the items are then arranged directly behind each other and are not distributed over the width of the page Consistency check Non productive Can be changed to lASHeadline items are deleted ASCombinedSelection IASHorizCombinedSelection ASStandardGroup lASAlternateStandardGroup or ASHorizont alGroup Productive Can be changed to ASCombinedSelection ASHorizCombinedSelection IAS Standard
39. lt 1 POS Name of Measurement Test or Synonym Qualifier of Long name For TESTCD Examples Platelet Systolic Blood PETEST yes Examination Gnaf 169 TESTCD Pressure Summary Min RR Duration Eye Examination Short character value for TEST used as a column name when PETESTCD Short Name of Measurement Char re Topic converting a dataset from a vertical format to a horizontal format yes Test or Examination q p Th e short value can be up to 8 characters Examples PLAT SYS BP RRMIN EYEEXAM PELOC yes Location of Dose Administration Char perm Record Qualifier Anatomical location of an intervention such as an injection site Example RIGHT ARM for an injection Synonym Qualifier of TRT If the value for TRT TERM or ORRES is modified for coding PEMODIES es Modnen Name Char perm TERM or ORRES purposes then the modified text is placed here PEREASND yes Reason Not Done Char perm Record Qualifier Reason not done Used in conjunction with STAT when value is NOT DONE Used to indicate when a question about the occurrence of a pre PESTAT yes Completion Status Char perm Record Qualifier specified intervention was not answered Should be null or have a v alue of NOT DONE PESCAT yes Subcategory Char perm Grouping Qualifier Used to define a further categorization of CAT values PECAT yes Category Char perm Grouping Qualifier Used to define a category of topic
40. mol L SCSTRESN yes Numeric Result Finding in Num perm Result Qualifier Used for continuous or numeric results or findings in standard Variable Prefix Variable label Type Core Role Description Standard Units format copied in numeric format from STRESC STRESN should sto re all numeric test results or findings Contains the result value for all findings copied or derived from ORRES in a standard format or in standard units STRESC sho uld store all results or findings in character format if results are nu Result or Finding in Standard a meric they should also be stored in numeric format in S TRESN SeSTRESO yes Format Char exp Result Gualter For example if various tests have results NONE NEG and NEGATIVE in ORRES and these results effectively have the same meaning they could be represented in standard format in STRESC as NEGATIVE SCCAT yes Category Char perm Grouping Qualifier Used to define a category of topic variable values SU Substance Use Interventions General Observation Class Variable Prefix Variable label Type Core Role Description a s Usually expressed as the number of doses given per a specific in SUDOSFRQ yes Dosing Frequency per Interval Char perm Variable Qualifier of DOSE terval Examples QD BID TID QID Description or date time in ISO 8601 character format of the spon SUENTPT yes End Reference Time Point Char perm Timing Variables s
41. null or have a v alue of NOT DONE Name of Measurement Test Synonym Qualifier of Long name For TESTCD Examples Platelet Systolic Blood ReneS YES or Examination Ghar ten TESTCD Pressure Summary Min RR Duration Eye Examination PCDTC yes Date Time of Collection Char exp Timing Variables Collection date and time of an observation represented in ISO 8601 character format PCTPTNUM yes Planned Time Point Number Num perm Timing Variables Numeric version of planned time point used in sorting Result or Finding in Original Le Result of the measurement or finding as originally received or col PCORRES yes Units Char exp Result Qualifier lected Examples 120 lt 1 POS aX ae Variable Qualifier of Indicates the lower limit of quantitation for an assay Units will be PCLLOQ yes Lower Limit of Quantitation Num exp STRESN those used for STRESU PCCAT yes Category Char perm Grouping Qualifier Used to define a category of topic variable values PCNAM yes Laboratory Vendor Name Char exp Record Qualifier Name or identifier of the vendor e g laboratory that provided the test results PE Physical Examination Findings General Observation Class Variable Prefix Variable label Type Core Role Description PEORRESU yes Original Units Char perm ae of Unit for ORRES Examples IN LB kg L Result or Finding in Original bas Result of the measurement or finding as originally received or col PEORRES yes Units Char exp Result Qualifier lected Examples 120
42. patient has been newly created only visits without treatment arms will be initially created When adding further visits the rules for the treatment arm visits will be evaluated and the first visit with a fulfilled treatment arm rule will be created Further visits in this treatment arm will then be created without new rule checks Item types Date time Take date from Date time interval Calculate date time interval from Date Scorefield Calculate date time interval from Score calculated only Calculate score function from Calculate normed score from Calculate score from Certain rules are firmly linked to the type and can only be used there In turn it is not usually pos sible to set other rules to these items Individual description Hide when Can be applied to All item components except DB Dummy All question components Condition Conditions from other forms or other visits The own item cannot be used as a rule condition The included items of a questions cannot be used as conditions for their enclosing question Type Action Completion status Check Initialisation Saving revalidation Form status Hidden items will be treated as non existent and will be ignored for the cal culation of the form status Casenode status No effect Error message No Effect Items and question will be hidden To specify the display of questions or items instead of hiding the conditions
43. perm Grouping Qualifier Used to define a further categorization of CAT values PCELTM yes Planned Elapsed Time from Time Point Ref Char perm Timing Variables Planned Elapsed time in ISO 8601 character format relative to a planned fixed reference TPTREF such as Previous Dose or Pre vious Meal This variable is useful where there are repetitive measures Not a clock time or a date time variable but an interva represented as ISO duration PCTPTREF yes Time Point Reference Char perm Timing Variables Description of the fixed reference point referred to by ELTM TPTNUM and TPT Examples PREVIOUS DOSE PREVI OUS MEAL PCTESTCD yes Short Name of Measurement Test or Examination Char req Topic Short character value for TEST used as a column name when converting a dataset from a vertical format to a horizontal format Th e short value can be up to 8 characters Examples PLAT Variable Prefix Variable label Type Core Role Description SYSBP RRMIN EYEEXAM PCENDTC yes End Date Time of Observation Char perm Timing Variables ee pits obseation lepresented in TAO Bor charac Used to indicate when a question about the occurrence of a pre PCSTAT yes Completion Status Char perm Record Qualifier specified intervention was not answered Should be
44. prerequisite check revalidation Form status Casenode status Error message Effect Usage Comment Input required Can be applied to Condition Type Check Form status Casenode status Error message Effect Usage Input required if Can be applied to Condition Type Check Form status Casenode status Error message Effect Usage Completion status If the rule is fulfilled and no input is made the field is regarded as complete although empty otherwise following input No effect Yes default No input allowed If one of the defined conditions is met the error message is displayed to the user and saving the form is impossible until he corrects his inputs or switches off the form check All forms This rule functions like Limit reached if but has an effect on the completion status and leads to an own input check All item components except DB Dummy Layout Dummy and all calculable items without entry Score Date Interval Date section No Form status Saving revalidation Completion status after input No effect Yes default Input required A user input in this field is vitally necessary the user is presented with the error message and cannot save the form until he has either entered any data or switches off the check Mandatory fields for important information All item components except DB Dummy Layout Dummy and all calculable items
45. present The displayed size in the form can be changed but the changes only apply for new uploaded forms Existing forms are displayed in the form the have been created during upload Non productive Can be changed to all item types which are permitted in the question Productive Cannot be changed Catalogfield The catalog field can only be created in an ASCatalogGroup The catalog elements which can be selected here are dependent on the question s catalog The catalog layer and precisely which in formation is to be read out from this layer must be determined in the item The options for this vary depending on the catalog The type and size of the input field portrayed in the form vary depending on the catalog definition and the selected catalog column On use in the DataCapture both direct input and selection via the catalog pop up are possible Type Catalogfield Catalog element Layer Operation Intervention column Ficd 76 lt Please choose gt Displayed order 20 shown no Operation Intervention EPCC code item ICD 10 additional Unit format HTML Database column licd10 D gt CDISC ODM export annotations Containing rules 0 Fig 48 Example of the creation of a catalog field in the Operation Intervention catalog in the FormBuilder In the example in Fig 43 the value is read out from the Operation Intervention layer in this case the information from this layer is the I
46. providing the table owner has not already been entered All tables which are used should be specified without scheme names On execution of the report these are added by the system depending on area and therefore enable the transfer of an SQL re Note Important port from the setup area to the productive area This also functions for tables in nested conditions and for tables from other projects in the same customer area Please do not specify any database users in front of the tables as this prevents the automatic transfer of the reports from the setup to the productive area If the tables which are used contain a project s casenode table a restriction to those centres in which the current participant is a member is automatically added to the defined statement Linking a report entry to the call up of a patient only functions if the report contains a pseudonym pseudonym Pat ID aid Add ID or labid Lab ID for the patient as a column specification The SELECT statement generated from the data is portrayed beneath the definition of the fields under the point SQL To increase the clarity the statement will be wrapped after each element e g FROMS Lines longer then 100 characters print preview 80 will be wrapped automatically at the last blank included The Test status link is available to test the validity of the generated SQL statement A small wait window then opens and the SQL is executed in the background If the stat
47. randomization button simple randomization must first be configured in the project and the names of the two randomization groups must be specified The equal distribution basis for randomisation can be configured in the FormBuilder You may select whether the patients are to be randomized per centre or project After pressing the randomisation button this disappears and the randomly generated subdivision into a group appears This assignment is immediately saved as a patient property by clicking the button Randomize Randomization gt Randomize Assigned to group A Fig 45 Various views of the randomisation button The button prior to randomisation is shown on the left after randomisation and saving the form the randomisation group is portrayed as a text instead of the button right The algorithm for determining a patient s membership of one of the randomisation groups is based on the basis of 4 and can be summarised as follows If an equal number of patients are contained in the randomisation groups the probability of assignment to one of the two groups is 50 50 f group A has more patients than group B the probability of the next patient s again being assigned to group A is only 10 90 In the event of an imbalanced distribution which is irrespective of the number of patients already contained in the groups a very low number of participating patients may lead to very imbalanced distribution into the individual grou
48. re meric they should also be stored in numeric format in S TRESN PARRES ce Format Char Exp Result ualer For example if various tests have results NONE NEG and NEGATIVE in ORRES and these results effectively have the same meaning they could be represented in standard format in STRESC as NEGATIVE PPORRESU yes Original Units Char expo Variable Quallierel Unit for ORRES Examples IN LB kg L ORRES Variable Prefix Variable label Type Core Role Description PPCAT yes Category Char exp Grouping Qualifier Used to define a category of topic variable values Result or Finding in Original we Result of the measurement or finding as originally received or col PPORRES yes Units Char exp Result Qualifier lected Examples 120 lt 1 POS Date Time of Reference Time Be a Date time for a fixed reference time point defined by TPTREF in PPRFTDTC yes Point Char exp Timing Variables ISO 8601 character format Name of Measurement Test or Synonym Qualifier of Long name For TESTCD Examples Platelet Systolic Blood PPTEST yes Pare Char req a nce Examination TESTCD Pressure Summary Min RR Duration Eye Examination y Defines the type of specimen used for a measurement Examples PPSPEC yes Specimen Material Type Char exp Record Qualifier SERUM PLASMA URINE Short character value for TEST used as a column name when Short Name of Measurement
49. represented in standard format in STRESC as NEGATIVE IETEST s Name of Measurement Test Char i Synonym Qualifier of Long name For TESTCD Examples Platelet Systolic Blood y or Examination q TESTCD Pressure Summary Min RR Duration Eye Examination LB Laboratory Test Results Findings General Observation Class Variable Prefix Variable label Type Core Role Description LBCAT yes Category Char exp Grouping Qualifier Used to define a category of topic variable values Date Time of Reference Time _ a Date time for a fixed reference time point defined by TPTREF in LBRFTDTC yes Point Char perm Timing Variables ISO 8601 character format Used to indicate when a question about the occurrence of a pre LBSTAT yes Completion Status Char perm Record Qualifier specified intervention was not answered Should be null or have a v alue of NOT DONE LBREASND yes Reason Not Done Char perm Record Qualifier Reason not done Used in conjunction with STAT when value is NOT DONE Short character value for TEST used as a column name when Short Name of Measurement converting a dataset from a vertical format to a horizontal format po ores Test or Examination char ted Topic Th e short value can be up to 8 characters Examples PLAT SYSBP RRMIN EYEEXAM LBTEST dE Name of Measurement Test or Char re Synonym Qualifier of Long name For TESTCD Examples Platelet Systolic Blood y Examination q TESTCD Pressure Summary Min RR Duration Eye Examina
50. required Input required Rules with condition Hide when Show treatment arm if Freeze casenode if Delete casenode if Display form if Confirm input if Input impossible if Input not required if Input required if Input required or ignore completion status if Input only possible if Hide when Free following forms if Freeze following forms if Free single form if Freeze single form if Form input not possible if Form input only possible if Limit reached if Generate message if Delete patient pseudonyms if Patient deceased if Freeze patient if Delete patient if Close adverse event if Limit value range if Rules with preconditions and execution conditions Take date from Calculate normed score from Calculate score from Calculate score function from Take value from Take value if same visit day from 3 2 Rule types and effects Example Rules may have completely different effects Certain of them only influence the completion status others limit the value range and others in turn trigger actions There are often two rules which de scribe the same result from different points of view e g Input impossible if and Input only pos sible if A check m
51. save the form until he has corrected the input or switches off the check Check of value range This rule functions like Input impossible if but has no effect on the completion status and does not lead to an own input check Generate message if Can be applied to Condition Type Check Form status Casenode status Error message Effect Usage Comments All item components except DB Dummy and Layout Dummy Depending on field type a message can be defined Action Saving revalidation No effect No effect No On meeting the conditions defined via parameters the previously defined message is sent i e is saved in the database and displayed when next logging in Intended for adverse events and serious adverse events or for other important data e g on reaching limits Depending on configuration the pseudonyms used in the project can be selected for displaying in the message Pat ID and or Add ID and or Lab ID The message can include questions of the form The type of sending via internal message or e mail is configured in the AdminTool For further informations on this type of message refer to see chapter 7 Calculate normed score from Can be applied to Condition Score Values from other form fields are linked with the specified operators Which field values are ignored on calculation and the number of meaningless values as of which calculation is to take place can be spec
52. the maximum number of characters are coded via TextArea x y with x number of lines and y number of characters The following options are currently available X 2 y 25 x 3 6 9 y 20 40 60 80 x 4 y 20 General examination Comment r Quer Please describe your y impression of the patient s condition Fig 40 Example of the view of a TextArea3 40 As the evaluation capability of free text inputs is very limited their use should be well considered In addition to the option of saving in the form the general comment function for each item exists in secuTrial for inputting additional comments When using the DDE function you can configure how a text item comparison should be carried out compare ignore case and whitespace ignore completely Format check The input is restricted to the maximum number of defined characters No other check regarding the type of input is carried out Consistency check Can be created in lASStandardGroup lASAlternateStandardGroup lASHorizontalGroup ASUnitGroup and HorizontalUnitGroup Productive Can be changed to TextArea or text field in which the total text length is greater than or equal to the text length of the productive version Lookup Table In the case of a lookup field values from a database lookup table are offered to the user in a selec tion list In the FormBuilder this list is created in advance for a project as a Imnp table Si
53. the first text paragraph for additional informations Context informationen Here the amount of displayed item information on the print page can be configured When selecting the option reduced only information regarding form family form question and item is displayed The information regarding visit respective adverse event and the document ID is then omitted Signature Replace here the label Signature with your own text A short online help explains the respective configuration options 5 7 Icon display This display reveals a summary of all status reports In the header individual status displays can be selected or deselected by clicking on the status type For icon reports you can select whether the report is sorted either by visit type or chronologically For example it may be that the used patient visits differ from each other in different treatment arms and displaying a combined overview would be difficult in the report When sorting by visit type the treatment arms are listed separately When sorting reports chronologically the patient visits are listed in the order of the current pa tient For projects using CPV reports can be sorted chronologically or by visit type ral Participant Dipl biol Susanne Schneider l secuiria Project Study1 31 08 2010 19 56 00 CEST Print Date 31 08 2010 20 13 CEST Close Icon overview Display the following states M Completion status M Review Frozen
54. the randomization button algorithm groups and stratification The stratification factors for Range minimization and Variance minimization can now be edited even if the randomization button has already been set to productive mode The existing stratfication factors can be edited or deleted and new stratification factors can be created Please consider the consequences of any configuration change carefully For every randomization button a message can now be defined that can be triggered directly with the randomization of a patient and independently from or depending on the number of possible ran domization options remaining Different randomization algorithms The available configuration options for the randomization button depend on which algorithm has been selected For implementing the configurable randomization the following algorithms are available The math ematical implementations of algorithms 2 to 7 were carried out by the Swiss Group for Clinical Can cer Research SAKK 1 Extended stratified block without list secuTrial 2 Range minimization 3 Variance minimization Static unstratified single block randomization Static unstratified multi block randomization Static stratified block randomization NO o fs Simple randomization 8 External randomization using list imports In the following the basic statistical principles and the configuration options of the various algorithms are explained Minimization 2
55. variable values Contains the result value for all findings copied or derived from ORRES in a standard format or in standard units STRESC sho uld store all results or findings in character format if results are nu Result or Finding in Standard s meric they should also be stored in numeric format in S TRESN PESTRESO yes Format Ghat xp RESU Quallner For example if various tests have results NONE NEG and NEGATIVE in ORRES and these results effectively have the same meaning they could be represented in standard format in STRESC as NEGATIVE PEDTC yes Date Time of Collection Char exp Timing Variables Collection date and time of an observation represented in ISO 8601 character format Role of the person who provided the evaluation Used only for res PEEVAL yes Evaluator Char perm Record Qualifier ults that are subjective e g assigned by a person or a group Ex amples ADJUDICATION COMMITTEE VENDOR fog a Method of the test or examination Examples ElA Enzyme Im PEMETHOD yes Method of Test or Examination Char perm Record Qualifier munoassay ELECTROPHORESIS DIPSTICK PP Pharmacokinetic Parameters Findings General Observation Class Variable Prefix Variable label Type Core Role Description Contains the result value for all findings copied or derived from ORRES in a standard format or in standard units STRESC sho uld store all results or findings in character format if results are nu Result or Finding in Standard
56. view of an ASHorizontalGroup with two items It is not sensible to integrate many more than approx two to three items per group as a full view is not otherwise guaranteed with all window widths The lASHorizontalGroup should therefore be tested individually and with various browsers In the case of excessively wide ASHorizontalGroups a horizontal scroll bar appears as table structures are not made up Normally the items are distributed evenly according to their number over the width of the page with 3 items each item therefore takes up 1 3 of the width of the page The Flexible column width can be configured instead the items are then arranged directly behind each other and are not distributed over the width of the page Consistency check Non productive Can be changed to lASHeadline items are deleted ASStandardGroup IASAlternateStandardGroup Productive Can be changed to ASStandardGroup IASAlternateStandardGroup Except catalog fields all item types can be created IASRepetitionGroup The lASRepetitionGroup offers the option of creating questions or an entire form in such a way that if necessary it can be repeated any number of times without reserving a high number of empty data base fields for this from the beginning The standard application area is drugs Per default e g a single question for a concomitant drug can be displayed here If more than one concomitant drug is available a More button
57. 1 No The status of the agpatient and casenode is set to To be deleted Further editing in this project is no longer possible A further consequence must be that the agpatient and the medical data of the casenode are deleted For casenode forms in genuine part projects Can be applied to All item components except DB Dummy Layout Dummy and all calculable items without entry Score Date Interval Date section Condition Depending on field type Type Action Check Saving Form status No effect Casenode status No effect Error message No Effect Shows a form deviating from the normal form order in a project In the FormBuilder a follow up form can be defined which is displayed directly afterwards if the rule condition is fulfilled in the DataCapture Usage Visit casenode and image forms When creating the rule in visit casenode and image forms other visit forms and casenode forms can be selected as follow up forms Adverse event forms When creating the rule in adverse event forms fur ther adverse event forms can be specified as follow up forms Take date from Can be applied to Time checked Time Date checked Date Condition The source of the date must be specified as the source The following are possible Visits visit plan date AdverseEvent examination or current date specification of the item as a parameter is omitted Type Value take over Check Initi
58. 725 x 0 7184 Subdivision into parameters should initially be considered Indicated by brackets here surface weight0 425 x height0 725 x 0 7184 The formula can now be implemented with the following parameter as the calculation always starts with the result 0 the first parameter should always be added Parameter 1 Add value read value out from question Weight multiplication factor 0 01 exponential function exponent 0 425 Parameter 2 Multiply by value multiplication factor 0 7184 read value out from question Height exponential function exponent 0 725 Calculate date time lag from When calculating date score fields as numbers or calculating intervals from time date interval fields defined date fields are required in order to perform the calculation To define these date fields select the Calculate date time lag from rule When creating one of the two item types this rule will always be automatically created The two date values used for the calculation will each be created as a new OR condition for the rule Freely defined date time entries the current date the current date plus time entries as well as val ues from items plus time value can be used for the calculation When selecting items only date or time fields are offered which have the same format as the current score date item Handling of NULL When creating rules it must be noted that not inputting values leads to the database NULL valu
59. All item components except DB Dummy Layout Dummy and all calculable items without entry Score Date Interval Date section Depending on field type Value range Saving form prerequisite check revalidation Completion status when the rule is fulfilled the field is regarded as complete otherwise following input No effect Yes default No input allowed A user input in this field is only possible if one of the defined conditions is met The error message is displayed to the user and the user can only save the form if he undoes his input or switches off the check Withdrawing data is not possible in the case of radiobuttons in this case therefore the reset radiobuttons should be used or you should attempt to work with other rules Conditional mandatory fields This rule functions like Limit reached if but has an effect on the completion status and leads to an own input check and this similarly to Input impossible if Free following forms if Can be applied to Condition Type Check Form status Casenode status Error message Effect All item components except DB Dummy Layout Dummy and all calculable items without entry Score Date Interval Date section Depending on field type select date field as cut off date only the 1st condition is evaluated Action Saving revalidation Review status SysFreeze withdrawn No effect in the casenode form in a visit form this
60. CEST 6 2 Medicine mnpprobmedics M M 02 06 2009 13 06 CEST 3 2 P Pet mnpprobpet O M 25 08 2010 11 07 CEST 3 3 Pregnancy mnpprobpregnant Oo M 02 06 2009 12 40 CEST 2 3 P Weeks mnpprobweek O Pregnancy lt Imnpprobpregnant gt M 02 06 2009 12 40 CEST 5 3p Description Favorite activities Database table Imnpprobactivity Lookup type O Extendable Simple hierarchical Created 30 08 2010 17 21 CEST Entries Setup DB 6 Displayed order Value Source o Watching TY Participant o Working in the garden Participant fi Reading FormBuilder Delete 2 Dan FormBuilder Delete B Singing FormBuilder Delete js Kang oo FormBuilder Delete New value Cancel Save and back _ Save top Fig 42 Only the entries input in the FormBuilder can be edited on the editing page for all project lookup tables The values additionally created by participants in the DataCapture can only be viewed When setting projects with lookup tables to productive status only the values entered in the Form Builder are taken over into the productive version of the project from extendable lookup tables Data input by participants in the test environment are ignored Extendibility involves the risk that the participants always simply re enter their value instead of searching for existing entries In the event of even slightly deviating notations e g spelling errors this then quickly leads to multiple entries of what is a
61. Day Month Year Hour Minute J J ttmmiijhh mm Fig 34 Different format displays for the date components top to bottom hide display with op tional fields displayed hide displayed displayed Item time span date time span compare with value Welcome gt Project gt form family gt Form gt Question gt Item gt Rule gt Condition Project Study 1 03 09 2010 12 12 08 CEST Form family Base Examination Form Diagnosis Question sample Item Time of sampling Rule Sequence position 10 Error message Parameter is read from own item this item Compare or Assign Operator equal value g Compare Value current date timespan v Added timespan 20 minutes Cancel Save and back Save top Fig 35 Creation of a condition for a time item In the FormBuilder the condition tem time span can be selected to create conditions for time or date items In this case the time span is always specified in the smallest unit of the item format If the compare with item e g has the format DD MM YYYY the time span is specified in days or if the format is HH MM in minutes The same principle also applies to the Current date time span type The specified time span can be positive or negative and is added to the item value or current date before evaluating the condition Format check The format check is implemented in precisely the same way as for the date
62. ERM yes Reported Term Char req Topic Topic variable for an event observation which is the verbatim or pre specified name of the event DSSCAT yes Subcategory Char perm Grouping Qualifier Used to define a further categorization of CAT values DSCAT yes Category Char exp Grouping Qualifier Used to define a category of topic variable values Standardized or dictionary derived name of the topic variable TRT or the modified topic variable MODIFY if applicable Eq DSDECOD yes Standardized Treatment Name Char req Synonym Qualifier of TRT uivalent to the generic drug name in WHO Drug or a term in SNOMED ICDS or other published or sponsor defined dictionar ies EG ECG Test Results Findings General Observation Class Variable Prefix Variable label Type Core Role Description EGCAT yes Category Char perm Grouping Qualifier Used to define a category of topic variable values Position of Subject During Ob m Position of the subject during a measurement or examination Ex EGPOS Yes servation Chat Dally Becerd Qualifier amples SUPINE STANDING SITTING Description of the fixed reference point referred to by ELTM EGTPTREF yes Time Point Reference Char perm Timing Variables TPTNUM and TPT Examples PREVIOUS DOSE PREVIOUS MEAL Planned Elapsed time in ISO 8601 character format relative to a planned fixed reference TPTREF such as Previous Dose or EGELTM yes Planned lapsed Time mom Char perm Timing Variables Pre vious Meal This va
63. Examples PREVIOUS DOSE PREVI OUS MEAL MBREASND yes Reason Not Done Char perm Record Qualifier E a ionewitiyass Tl Alawheney aE ls MBTPTNUM yes Planned Time Point Number Num perm Timing Variables Numeric version of planned time point used in sorting Variable Prefix Variable label Type Core Role Description Date Time of Reference Time ee Date time for a fixed reference time point defined by TPTREF in MBRFTDTC yes Point Char perm Timing Variables ISO 8601 character format Location of Dose Administra ose Anatomical location of an intervention such as an injection site MBLOG yes tion Ghat Pern Recor Qua MET Example RIGHT ARM for an injection MBCAT yes Category Char perm Grouping Qualifier Used to define a category of topic variable values MBSCAT yes Subcategory Char perm Grouping Qualifier Used to define a further categorization of CAT values Short character value for TEST used as a column name when Short Name of Measurement converting a dataset from a vertical format to a horizontal format NTE SIGO YES Test or Examination Char 184 Topig Th e short value can be up to 8 characters Examples PLAT SYSBP RRMIN EYEEXAM Text description of time when a measurement or observation ee should be taken as defined in the protocol This may be represen MEET yes Planned ms PolntName enar penn Timing vanables ted as an elapsed time relative to a fixed
64. Group lASAlternateStandardGroup or ASHorizontalGroup Only lookup tables not extendable can be included After creating the first lookup table only the lookup tables hierarchically positioned below the first can be selected IASCombinedSelection In content terms virtually the same function as ASMultipleSelection with the sole difference that only the first pull down list is pre loaded when loading the page The layout is vertically beneath each other Highly suitable for the portrayal of large hierarchically structured lookup lists ASCombinedSelection Comment Query Pet lt Please choose gt y Breed i Colour Fig 17 Example of the view of an ASCombinedSelection Without selecting the upper lookup table no entries are yet displayed in the lower lookup tables Consistency check Non productive Can be changed to lASHeadline items are deleted ASHorizCombinedSe lection ASMultipleSelection ASStandardGroup lASAlternateStandardGroup lASHorizontal Group Productive Can be changed to ASHorizCombinedSelection ASMultipleSelection ASStand ardGroup lASAlternateStandardGroup IASHorizontalGroup Only lookup tables not extendable can be created IASHorizCombinedSelection In content terms the same function as ASCombinedSelection but the layout is horizontally next to each other In the case of a high number of items or lookup tables with very long contents this lay out may becom
65. ICOM header and DICOMDIR are pseudonymised Individual DICOM images or entire series can be uploaded these are then stored in a zip file on the server to gether with a newly generated DICOMDIR file The applet viewer is unsuitable for diagnosis When using the DDE function you can configure how an image item comparison should be imple mented Compare text only Compare including hash values or ignore completely The comparison with the hash value takes into account the checksum of the image binary data which is saved when uploading This can be used as a type of image content comparison In a nor mal comparison only a text representation of the image is compared with the image name image size and file size Format check In principle any files can be uploaded although this component has primarily been developed for the portrayal of images Other file types are then symbolised via icons The uploaded im ages are scaled and converted for displaying Editing is carried out either via the integrated Java functions or the external programme ImageMagick Consistency check Use only in saved forms and not in subforms The Image component can also be used outside of Image families but this component can only be configured in these to portray a form thumbnail On use of rules the image item can only be compared with the value NULL Testing can therefore only be carried out to determine whether an image is
66. PC 10 code In contrast to lookup tables or pop up items the selected catalog values are saved verbatim in the form data record This leads to the fact that the form inputs are independent of catalog changes The catalog entries can be changed in the FormBuilder with the aid of catalog reloading Format check On saving a check is carried out to determine whether all inputs are also present in the spe cified location in the catalog A check is also carried out to determine whether the combination is present in precisely this manner Non specified upper layers are additionally added Non specified lower layers can be left free Consistency check Can be created in ASCatalogGroup only Non productive productive Cannot be changed 2 5 Layout note Questions can be created with several items In this case almost any combination of individual types is possible To obtain the most uniform eCRF layout possible it is advisable to formulate the questions and answers on the same layer wherever possible In the example below the formulations Sex Date of the examination and Allergies have been specified on the Question layer The fourth ASStandardGroup contains no displayed question text Only a text which is displayed in the ExportSearchTool to enable the selection of questions has been input in the FormBuilder in this case The questions Dog Cat have been input on the layer of the relevant items All answer o
67. Product Description II FormEngine secuTrial Valid for version 4 8 As of 29 09 2015 interActive Systems Berlin A saa a a aaa aaa a aan a a iaa a G EAN 6 1 1 The FormEngine translator between database and HTML form ceeseeseeeeeeeeeeneeeeeteeeeeees 6 1 2 Page structure of an eCRF in the DataCapture oooooccccccocococcccccnonancncncnnnonnnnnnnnnnonnnnncnnnnnncnnnnnnnnnnns 7 KS FORMSTUCU ardid baxnyaneana ox cetbensax uatictiaemaneh aneeabbedanetinatns 7 1 4 Reports and Statistics ici dnd adas 8 Lo Form Tamily POS viii Idea 9 MiS a di taaan 9 PS DEL ELL y EP POC OOO O O sine eebnebenticd as sicwesntaueshiaddeddaduiveadeannam 9 CASEN ira a A 9 MAJO tia a O e rotondas 9 SUD Micol E E idad 10 FOFM COMPONENES sinoi AAA ARA ARAGAO AR air 11 2 1 Value check in the DataCapture oooocccccccnnnnnnnoonononnncononcnnnncnccnnnnnnnnnnrnnnnnnnnnnnnnnnnnrnninnnnnnnncnnnnnns 11 Format necia daa 11 RU ii e a 11 2 2 Consistency check in the FormBuilder oooooooccnnnnnnccccccccnonoaccnnnnnnnncnnncnnnnnnnnnnnnnnnnnnnnnnononeneneninos 11 A DOS sr eemernetengan A E A E E cat anise Hama AE netratdiauae se emiateanens 12 EEE EC 12 IASAlternateStandardGrouD cccccccceceeeeeeeeeeeeeeeeeeececeacaeeeeeeeeeeeeeeeeeeteeeseecceeeneneceeeeeeeees 12 VAS CAINS icon deci acid 13 IASHorizONtalGrOUP ccccccccnnnnncnonononoccnoncnnnncncnnn cnn nn nn n nn nn nn nn n nn n nn nn nn nr nn EEE EE rra 14 IlASRepetitiONGTOUP ccoc
68. Record Qualifier MedDRA associated with an event Example GASTROINTESTIN AL DISO RDERS CETERM yes Reported Term Char req Topic Topic variable for an event observation which is the verbatim or pre specified name of the event CEREASND yes Reason Not Done Char perm Record Qualifier Reason not done Used in conjunction with STAT when value is NOT DONE Used to indicate when a question about the occurrence of a pre CESTAT yes Completion Status Char perm Record Qualifier specified intervention was not answered Should be null or have a v alue of NOT DONE Used to record whether a pre specified intervention occurred when CEOCCUR yes Occurrence Char perm Record Qualifier information about the occurrence of a specific intervention is s oli cited CEPRESP yes Pre specified Char perm Record Qualifier Used when a specific intervention is pre specified on a CRF Val ues should be Y or null CESCAT yes Subcategory Char perm Grouping Qualifier Used to define a further categorization of CAT values CECAT yes Category Char perm Grouping Qualifier Used to define a category of topic variable values Description or date time in ISO 8601 character format of the spon CEENTPT yes End Reference Time Point Char perm Timing Variables sor defined reference point referred to by ENRTPT Examples 2 003 12 25 or VISIT 2 CM Concomitant Medications Interventions General Observation Class Variable Prefix Variable label Type Core Role Description CMDOSFRM yes Do
69. SAlternateStandardGroup lASVertRBMatrix Productive Can be changed to lASVertRBMatrix lASStandardGroup IASAlternateStandardGroup lASHorizontalGroup Only horizontal radiobuttons can be created TASVertRBMatrix In an IASVertRBMatrix the questions are arranged vertically in columns and the answers horizontally in lines They are suitable for the rarer case of question groups with short questions and longer answer texts as these would not otherwise fit well into the narrow column designations One example is the UPDRS score in which the same questions are asked for various extremities head LU RU LL RL etc whilst the answer options are half sentences The Horizontal radiobutton is also used as an internal item type in this vertical radio matrix as this component s layout is determined by the question type only and not by the item type For the ASVertRBMatrix it is also possible to display a reset option see ASHorizontalGroup It is also possible for the ASVertRBMatrix to influence the table design via the CSS layout settings RIGIDITY Comment Instructions to examiner Rigidity is judged on slow passive movement of major joints with the patient in a relaxed position Query and the examiner manipulating the limbs and neck First test without an activation maneuver Test and rate neck and each limb separately For arms test the wrist and elbow joints simultaneously For legs test the hip and knee joints simultaneo
70. SStandardGroup lASAlternateStandardGroup lASHorizontalGroup ASUnitGroup ASHorizontalUnitGroup Non productive Cannot be changed as long as score rules are created for this item Productive Cannot be changed Date score fields for calculation in numbers With date score fields time interval calculations are carried out between two dates The determined intervals are expressed as numbers for the purposes of further calculation The unit of measurement is the smallest time unit entered If the date value is entered as dd mm yyyy the result is calcu lated in days When this item is created the calculation rule Date and time interval is calculated from is automatically created at the same time For this rule there are then two time fields which must be set up as a condition for making the calculations Seconds M S calculated only Seconds H M S calculated only Minutes H M calculated only Minutes Y M D H M calculated only Days Y M D calculated only Months Y M calculated only Years Y calculated only Note Exception The interval calculation is carried out in the form via the score button just as with the numerical scores The calculated value is displayed as text A search for the interval field is performed by en tering numerical values or value ranges just as with numerical fields Format check Not necessary Consistency check Can be created in lAS
71. StandardGroup lASAlternateStandardGroup lASHorizontalGroup ASUnitGroup lASHorizontalUnitGroup Non productive Cannot be changed as long as score rules are created for this item Productive Cannot be changed Configurable Randomization Button This button makes it possible to randomly distribute patients in one of two or more groups In order to use the configurable randomization button configurable randomization must be set up in the pro ject This option enables multiple randomizations To do this multiple randomization buttons can be created which can then be individually configured with regard to randomization algorithm randomiz ation groups and randomization stratification This item component can be used in two different ways Randomization per button When used in forms without Randomization processing the ran domization is performed in DataCapture by clicking on the button It is saved immediately inde pendent of the form data Randomization by saving In forms with Randomization processing the button will not be displayed on the component Instead the randomization will be performed when the form is saved Even if the randomization button is displayed in multiple visits via one and the same visit form the randomization process can only be performed once for the individual component After the project has been set to productive mode it is no longer possible to change the basic con figuration of
72. T DONE EGSCAT yes Subcategory Char perm Grouping Qualifier Used to define a further categorization of CAT values EX Exposure Interventions General Observation Class Variable Prefix Variable label Type Core Role Description EXENDTC yes End Date Time of Observa Char perm Timing Variables End date time of the observation represented in ISO 8601 charac tion ter format EXSCAT yes Subcategory Char perm Grouping Qualifier Used to define a further categorization of CAT values Description of the fixed reference point referred to by ELTM EXTPTREF yes Time Point Reference Char perm Timing Variables TPTNUM and TPT Examples PREVIOUS DOSE PREVIOUS MEAL Describes reason or explanation of why a dose is adjusted Ex EXADJ yes Reason for Dose Adjustment Char perm Record Qualifier amples ADVERSE EVENT INSUFFICIENT RESPONSE NON MEDICAL REASON EXVAMTU yes oe Mehicle Amount Char perm eves Qualilienot Units for the treatment vehicle Examples mL mg EXVAMT yes Treatment Vehicle Amount Num perm Record Qualifier Amount of the treatment vehicle administered or given A FA Vehicle for administration of treatment such as a liquid in which EXTRTV yes Treatment Vehicle Char perm Record Qualifier the treatment drug is dissolved Example SALINE EXTPTNUM yes Planned Time Point Number Num perm Timing Variables Numeric version of planned time point used in sorting Location of Dose Administra Pe Anatomical location of an intervention such as an injectio
73. Time Point Name Char perm Timing Variables should be taken as defined in the protocol This may be represen ted as an elapsed time relative to a fixed reference point such as time of last dose See TPTNUM and TPTREF Variable Prefix Variable label Type Core Role Description QSTPTNUM yes Planned Time Point Number Num perm Timing Variables Numeric version of planned time point used in sorting Planned Elapsed time in ISO 8601 character format relative to a planned fixed reference TPTREF such as Previous Dose or QSELTM yes Planned Elapsed fang mam Char perm Timing Variables Pre vious Meal This variable is useful where there are repetitive Time Point Ref h x measures Not a clock time or a date time variable but an interva represented as ISO duration Description of the fixed reference point referred to by ELTM QSTPTREF yes Time Point Reference Char perm Timing Variables TPTNUM and TPT Examples PREVIOUS DOSE PREVIOUS MEAL Date Time of Reference Time as Date time for a fixed reference time point defined by TPTREF in QSRFTDTC yes Point Char perm Timing Variables ISO 8601 character format QSSCAT yes Subcategory Char perm Grouping Qualifier Used to define a further categorization of CAT values SC Subject Characteristics Findings General Observation Class Variable Prefix Variable label Type Core Role Description Result or Find
74. XP Recor Sualiticy munoassay ELECTROPHORESIS DIPSTICK Contains the result value for all findings copied or derived from ORRES in a standard format or in standard units STRESC sho uld store all results or findings in character format if results Result or Finding in Standard i are numeric they should also be stored in numeric format in S MESTRESS yes Format Chiat exp Real alme TRESN For example if various tests have results NONE NEG and NEGATIVE in ORRES and these results effect ively have the same meaning they could be represented in stand ard format in STRESC as NEGATIVE MBBLFL yes Baseline Flag Char perm Record Qualifier Indicator used to identify a baseline value Should be Y or null Used to indicate when a question about the occurrence of a pre MBSTAT yes Completion Status Char perm Record Qualifier specified intervention was not answered Should be null or have a v alue of NOT DONE Planned Elapsed time in ISO 8601 character format relative to a Planned Elapsed Time from planned fixed reference TPTREF such as Previous Dose or MBELTM yes Zap Char perm Timing Variables Pre vious Meal This variable is useful where there are repetitive Time Point Ref E A B A measures Not a clock time or a date time variable but an interva represented as ISO duration Description of the fixed reference point referred to by ELTM MBTPTREF yes Time Point Reference Char perm Timing Variables TPTNUM and TPT
75. a are saved one after the other in a list For the stratification via the data of the current patient only the respectively applicable section of the complete list is determined and then assigned Restriction restricted or unrestricted With a restricted list the entered ratio cor relates exactly With unrestricted lists small deviations are possible Group allocation by Accrual or Ratio see below Randomization groups At least 2 Weighting of the groups Accrual specification of the number of patients per group Ratio specification of the ratio of the groups to each other specification of the number of patients when generating the list in the AdminTool Stratification Required Randomization list Required created in the AdminTool 7 Simple randomization This very basic algorithm simply involves the random selection of one of the defined randomization groups It does not take into account any other ancillary conditions ratios or previously conducted randomizations The number of randomizations is only limited if the randomization is blinded Randomization groups At least 2 Randomization lists Only for blinding 8 External randomization using list import 5481 The randomization algorithm is pre defined by the order of the groups in the imported list The ran domization itself then follows the second step of the block list randomization for the stratification via the data of the current patient only the
76. aO Table alias C C Column OB Title Completed O DB function tease when fisformcomplete d completionstatus 1 then Yes else No end Y Variable name Ba Ordered by I lt Please choose gt zj Remove 4 Display C hidden shown I sortable I selectable Y Table nnpprobpersdata O Table alias JN Column OG Title Bnmae amp DB function valueto_datembithdate DDMMYYY O Variable name Wa Ordered by k Please choose gt 5 Display C hidden shown I sortable I selectable Y Table SSCS Table alias en Column E O Title E O DB function value_to_label mnpprobpersdata gender m gender Variable name MSO Ordered by k Please choose gt z Remove L New column Conditions where 1 Left table e Fig 54 Upper part of the editing page of the SQL report from Fig 52 with specification of the portrayed values The validity of an SQL report can be checked from the report overview using the Test status link New column Conditions where fl Left table IP BD Left column fide Predicate Right table pobcasenode si i i Ss S S O OOOO O C Right column pid Right constant gt compare value Remove 2 Left table probcasenode D Left column cnid Predicate Right table probcasevisitplan Right column cnid Right constant Sy compare value Remove 3 Left table probcasevisitplan a Left column evpi
77. ae ibid a aa aia e aa a 65 Limit PEACHES AO 66 Generate message useisiin ena A a aaas 66 Calculate normed score FOM aa a r r a a a ae e a a aaar aai 66 Delete patient pseudonyms if ooo cece cece cece eeeeeeeeeeeeeeeeceeeeeeeeeeeeeeeaaaaeceaeaeaeaeeeeeeeeeeaaeneeeees 67 Patient deceased if cerere sa dt int nee heei 67 EFGOZe Daten if isis aere ea e isa aeaa eain eae ara a eae arnee denan Kata Eaa aaaea es 68 Delete pati nt ista ta dla 68 Calculate Score MOM ies titanio lia di atera de 4h 68 Calculate score function fiom cidde dae ea daare eae aana etd a a Aa anaa 69 Open serious adverse event if ccccccccccceeeeeee eee eeeeeedceceaeaeeeeeeeeeeeeeeeeeeeeeseseeeceeeeeeeeeeaes 69 Close adverse eventif ocre nke aee aeara ria tea a a mahea 69 Open adverse event i a a css ea a E at ind 70 ake Value fromi Are enai ltda aar a aa o e aa aaa 70 Take value if same visit day frOIM ce eeceeeceeeeeeeneeeeeeeeeeaeeeeeseeenaeeeeeseeenaeeeeeeeeeeeeeeeeeeeeeeteeeess 71 Limitvalle tange iia lb id geese 71 o O 71 Calculate score MOM aros 73 Calculate normed Score from ooooccccccnninnnnnnnonononnncnnnnnnnnnnnnnnnnnnnnnnnn nn nn nnnnnnnnnnnnnnnnrnninnnnnnnnnnnnes 73 Calculate score function from ooooooccccccccnnconnnnnnononnnononnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnneninicnns 73 Calculate date time lag from ooonoocccccnnnoccccccnonanancncnonnnoncnnnnnnnononcnnnnnnnnnnnnn naar nn cn cr NRE ninas 74 Handling NOL ee o oca
78. aken over into the current field if the date of the form visit is the same as the date from the origin value Sensible for taking over information with a high probability of re maining identical from previous visits e g date of birth sex With the as signment operator take value add value a value is specified which will then be added to the adopted value in the form Visit forms as a convenience method Number Date checked Date Time checked Time Horizontal vertical Radiobutton Popup Depending on field type specification of a max and min value Action Saving revalidation Completion status after input No effect Yes default Limit reached On meeting one of the defined conditions and non adherence to the specified value range the error message is displayed to the user and he is unable to save the form until he has adapted the value or switched off the check Conditional check of value range A score is a value which is calculated from various user data in other items Simple scores can be used to simply count answers If e g an entire question catalog always has the answer options Yes No whereby yes is saved with 1 and no with O in the database the number of questions answered Yes can be quickly determined by totalling all database values Scores are defined via rules The calculation of a score is specified by the execution conditions of the rule The execution of a score rule can be restric
79. alisation of unsaved forms or new repetition groups Form status No effect Casenode status No effect Error message No Effect The date is taken over from the corresponding meta information and the field is pre assigned With the assignment operator take value add value a value is specified which will then be added to the adopted value in the form Usage Date fields convenience rule Calculate date time interval from Can be applied to Date Time Interval nur berechnet Date Time section as a digit nur berechnet Condition Fields from which the value is to be calculated Type Action Check Calculation of button click and during saving revalidation Form status Completion status on saving Casenode status No effect Error message No Effect When calculating date score fields or intervals from date time interval fields defined date fields are needed to perform the calculation For defining these date fields the rule calculate date time interval from has to be chosen and the two date fields have to be specified as the rule conditions Usage For calculating time intervals Confirm input if Can be applied to Condition Type Check Form status Casenode status Error message Effect Usage Ignore for completion Can be applied to Condition Type Check Form status Casenode status Error message Effect Usage Ignore for completion Can be applied to C
80. alue is fed back in the specified format The item value will only be reformatted and not be converted into a real date sorting alphanumeric The following formats are possible YYYY YYYY MM YYYY MM YYYY HH MI DD MM YYYY HH MI DD MM YYYY HH MI SS DD MM YYYY HH MI SS HH MM HH MM SS HH MM DD MM YYYY HH MM DD MM YYYY YYYY MM DD YY MM DD YYYY MM DD HH MI STANDARD_DATE value format language For complete date only form items the language has to be supplied as third parameter for month names possible values DE EN FR The following date formats are possible DDMMYYYY DDMONYYYY YYYYMMDD YYYYMONDD VALUE_TO_LABEL table column value For radiobutton and pop up items After specifying the form table and the field column the specified numerical value is converted into the corresponding label Table and column name has to be given in lower case and enclosed by single quotation marks The parameter list of this function is increased by the system With little response options the use of the SQL standard function CASE is recommended due to the faster execution IS_OVERDUE date For marking exceeded visit date values If the transferred real date is NULL or already exceeded an exclamation mark with HTML marking red bold is fed back otherwise a forced blank ISFORMCOMPLETE completionstatus For checking the form s completion status If the complete flag is set
81. articipient ptnid TPXcasevisitplan cv pid TPXcasenode cnid v TPXadverseevent aeid A A E A AA TPXaefollowup fuid oo HS TPXdocument mnpdid A a yi TPXdiscre pancy atTPX sdv K2 Customer DB prefix TPX Project DB schema to 1 relation to N relation Database schema user The primary key is displayed after the table name Renamed foreign keys are displayed at the relations Form data K2 Customer DB prefix TPX Project DB schema y i mae RRS TE to7 relation Centre ctrid Patient pid Participient ptnid gt to N relation i Database schema al user devTPX TPX The primary key is displayed after the table name Renamed foreign keys are displayed at the relations TPXcasevisitplan cv pid TPXcasenode cnid TPXdocument mnpdid a ptopdid parentdig AtT PXdocument mnpatdid atTPX subdocument ETES er J H Form formid t J J H Casenode forms x w 3 Se gt oO
82. atient deceased if Can be applied to Condition Type Check Form status Casenode status Error message All item components except DB Dummy Layout Dummy and all calculable items without entry Score Date Interval Date section Depending on field type Action Saving revalidation No effect Yes mnpcs0 is set to 1 No Initially none in the own form On meeting one of the defined conditions the patient status is set to Inactive Alls forms are frozen for further editing When logging in next the patient can no longer be edited at all he is no longer listed or found As a consequence the patient s pseudonym can be deleted in the AdminTool Patients with the status Inactive are also no longer found by the ExportSearchTool Casenode forms if the patient partially withdraws his consent Anonymisation All item components except DB Dummy Layout Dummy and all calculable items without entry Score Date Interval Date section Depending on field type Action Saving revalidation No effect Yes mnpcs4 is set to 1 No Effect Usage Freeze patient if Can be applied to Condition Type Check Form status Casenode status Error message Effect Usage Delete patient if Can be applied to Condition Type Check Form status Casenode status Error message Effect Usage Usually none in the own form On meeting one of the defined conditions the patient statu
83. ause of references The references can be viewed in detail by opening the references popup linked to the undeletable note 3 1 Rule types and conditions One or more rules can be created for each database field i e for each item The rules which can be used are often restricted by the type of item or the database field The Hide when rule can be created also for all question types including headlines I ASHeadline A rule usually describes the effect which is to occur on fulfilment of the rule Further conditions which describe the prerequisites under which the rule is fulfilled are usually required to fulfil the rule These rules are marked in the text with f The following generally applies Rules are linked by AND conditions by AND and OR Rule condi tions are evaluated in the order they were created and logically linked When setting or conditions only one condition must be met to fulfil the rule In contrast in order for a question check to be suc cessful and enable saving all and conditions and rules must be fulfilled Rules and conditions are checked independently of each other For value adoptions and scores preconditions and execution conditions can be defined Precondi tions describe the situation in which the rule is applied only definition similar to the rule Input re quired if Execution conditions describe the value to be adopted or the value calculation Rules without condition Input not
84. be configured Incorrect inputs lead to error messages including the incorrect input The input field is reset to the previous value Format checks are only implemented for item types with free input of course such a check is not necessary in the case of types with specified answer options e g radiobuttons It is impossible to save an incorrectly formatted input The catalog items are an exception to this In this case it is possible to ignore a datum s deviation from the current catalog by means of the Check data check box and to still save the values which are not present The deviation is then evaluated as an error Rules The limit value and plausibility checks and the execution of actions are defined via the item rules defined in the FormBuilder The calculation algorithm for score items is also created as a rule This then defines the sequence and origin of the form values to be calculated with each other The item value therefore only results from the evaluation of the rules 2 2 Consistency check in the FormBuilder Consistency checks are carried out in the FormBuilder when creating and editing form descriptions They determine which types are offered on the question item and rule layers Which conversions to other types are possible when and which other elements can be created are listed beneath the description for each component type in this section The consistency check serves two objectives Prevention of data loss
85. can be used to load one or more further empty fields with the same layout With an lASRepetitionGroup an empty shell for the fields to be repeated is simply created in the main form The contents themselves all questions and items in the repetition area must be created in a separate form of the Subform type This subform is then selected in the surrounding repetition question Concomitant Medication Please enter all additional medications Medication 1 Medicine Dose Ingesting time Comment CIL mg H hh mm Query Delete Nore Fig 8 Example of the view of an IASRepetitionGroup with an initial display of a subform repeti tion a further question group subform can be displayed via MORE The number of initial and maximum repetitions can be defined The More button can be replaced by another one it must then already be present on the web server If nothing is specified the standard icon is used Whether a DELETE button is to be displayed is defined for each IASRepetitionGroup A button other than the standard button can also be defined here attention This button must be present on the web server too Concomitant Medication Please enter all additional medications Medication 1 Medicine Dose Ingesting time Comment CH mg W hh mm Query Delete Medication 2 Medicine Dose Ingesting time Comment E mg CH hh mm Query Delete Medication 3 Medicine Dose Ingesting time Comment E mg CH hh mm Su r Delete Nore Fig
86. catalogue field from the catalogue compon ent and the conversion numeric field from the UnitGroup components 2 4 Item types The item types are described in the sequence in which they are offered in the FormBuilder Non productive items can normally be changed to any item unless The external type prescribes a specific item type The item is referenced by a rule Other restrictions are described under the corresponding types On conversion of items all captured test data are usually lost as the corresponding column is de leted and recreated on changing the data type Horizontal radiobutton The so called radiobuttons can be used very well to operate questions which are answered accord ing to the scheme Yes No or Little medium a lot Only one option can ever be selected with these types In this case the number of selectable options with yes no e g two and the text of the individual answer options e g Yes no not applicable must be specified This type is easy to im plement and operate resulting in a low error possibility good data quality Many questions can be implemented in such an option form In the medical data record the selected option is saved as an integer which is specified as DB value on creation of the radiobutton label This principle also applies to pop up items which is why switching between these types can usually be carried out Whilst lookup tables in contrast are als
87. cel each other but are both executed Caution Freeze single form if Can be applied to All item components except DB Dummy Layout Dummy and all calculable items without entry Score Date Interval Date section Condition Depending on field type Type Action Check Saving revalidation Form status No effect Casenode status No effect Error message No Effect If a rule condition is fulfilled the form which has been specified in the rule will be frozen everywhere that it is displayed Is it a visit form it will be frozen in all previously created visits However if the form is to be dis played in visits which have not yet been created it can be filled in after these visits have been newly created Usage Selective premature cancelling of data capture in a defined form Caution with the combination with Free single form The rules do not cancel each other but are both executed Form input not possible if Can be applied to All item components except DB Dummy Layout Dummy and all calculable items without entry Score Date Interval Date section Condition Depending on field type specification of the item as a parameter is omitted Type Action Check Form prerequisites check Form status No effect Casenode status No effect Error message No Effect This rule has no effect whatsoever in the form in which it is created It is intended to be selected as a prerequisite in other forms E g Hea
88. ch month In the case of the statistics Patients over visits three results are always portrayed The first result represents the number of all patients The second result represents the number of patients which have stored forms in this visit The third result represents the number of patients with a specific visit status see Evaluated status In the case of this statistics type cumulative portrayal means that the first result also contains the patients from the two other results and the second result those from the third Statistics Study 1 3 Recruitment statistics gt f Patients over time Remove Vv 2 Title Patients according centres over time Remove Category Recruitment Time configuration Month time period MM YYYY gt label x axis Created evaluated date patient in project Evaluation Cumulative frequency Label x axis Label y axis Chart type line chart z Generation per project y Fig 73 Example Statistics with completion status selected as Evaluated status and Cumulat ive frequency as Evaluation In the same statistics type absolute portrayal means that the first result contains only those patients which have been created but not yet saved forms The second result represents all patients which have been saved but are not yet complete The third result represents only the completed visits see Fig 73 On portrayal of data statistics over al
89. changed Score only calculated For a more detailed description see Scores at the end of the document Scores are saved as num ber fields in the database The accuracy or pre and post decimal places arises from the fields and formulae used for the calculation If a value is read out from a radiobutton or pop up item to calculate a score the entered conversion factor is used if one has been defined instead of the DB value of a label label answer option In the case of e g evaluations this can be used to evaluate just one of several possible answers as correct 1 and all others as incorrect 0 in order to then count all correct answers Configuration of the post decimal places The number of post decimal places can be configured in the FormBuilder If no configuration is carried out in the FormBuilder the number is determined as follows Ifa division operator is used at least two post decimal places are calculated Atleast the number of post decimal places in the used number input fields are used In the case of a simple score at least 0 post decimal places are used in the case of the normed score or the score function at least two post decimal places The highest number from the upper three specifications is taken If O has been determined as the number of post decimal places all calculated post decimal places are displayed precisely as they are calculated necessary on use of a point conversion factor w
90. changed form values has been configured from you for this message type this will always exclusively be used for questions from the current message form Only with these questions it is possible to compare the current values with the last entries in the audit trail For all other questions the time of the message dispatch does not correlate with the date of saving the data in the audit trail Note Dispatched form questions Markup of changed form values Displayed order Form Question Source Visit Attach images 110 lt same form gt 10 Frage 1 current visit 20o lt same form gt 30 Subform current visit 30 Statistics lt mnpnSform3 gt 20 HRBM current visit O Form questions add Form Question Casenode lt mnpn5cnform1 gt 10 Frage O Add images as attachments Source Visit Casenode Y Fig 77 Adding form questions specifying the visit and selecting the attach image option on the message editing page For questions that are included in the message and contain image items you can also select wheth er saved image files are to be attached to the message If an image attachment has been selected for at least one question the message will be automatic ally set to HTML and can no longer be changed For messages that are only sent internally within secuTrial no images can be attached even if this has been specified in the message definition Only images smaller than 5 MB can be sent When creating me
91. cified with the label corresponds to the column number into which the check box is assigned Format check Not necessary Consistency check Can be created in lASStandardGroup lASAlternateStandardGroup lASHorizontalGroup IASCheckboxMatrix ASUnitGroup and lASHorizontalUnitGroup Non productive Cannot be changed in a IASCheckboxMatrix Productive Can no longer be changed Time The time field is used to enable time data to be input There are three different variants which differ depending on which time units are to be specified In these variants H stands for hours M for minutes and S for seconds In the database time is saved in the same format as date J oe Quer Time of sampling hh mm i Date of sampling LU g dd mm yyyy Fig 33 Example of the view of a time and a checked date item After selecting the item type you can define whether the formatting display should be shown next to the entry fields The following options can be selected display hide display with optional fields With the last option all not mandatory fields in the format will be placed in brackets This option is not available for checked time components Only last option is mandatory Comment Hour Minute Second PY Jl at Day Month Year HH th mm Ji Day Month Year Hour Minute Tu Y WW tt mm jjj hh mm All options mandatory Comment Hour Minute Second CHH aan Day Month Year HWH tt mm jj
92. cnid 608 centre Test randomgroup B test assigndate 2012 04 04 12 30 53 Etc GMT 4 cnid 609 centre Test randomgroup A test assigndate 2012 04 04 12 43 00 Etc GMT 5 cnid 610 centre Test randomgroup A test assigndate 2012 04 04 12 52 08 Etc GMT predicates item strata mnpiasOdemographie sex 2 mnpiasOdemography year of birth gt 1960 randomgroup list of strata 1 A test randomgroup count A test gt 1 B test gt 0 Format check Not necessary because no user entries or selections are made Consistency check Can be created in ASStandardGroup lASAlternateStandardGroup and lASHorizontalGroup Productive With the exception of the randomization messages the names of the randomization groups and the import identifier for stratification factors are all important configuration settings for randomization and cannot be changed after the item has been set to productive In addition there are also a number of tests beforehand to ensure that the overall configuration remains consistent When copying or importing forms with randomization buttons between projects where different randomization configurations have been selected or in form families where randomization is not permitted the randomization buttons may not be copied or imported as well Project the project settings for simple and configurable randomization with optional blinding cannot be changed if a corresponding ra
93. cted in the following content breakdown Form number form name plus form description Intermediate number intermediate header Question number question plus description and help text Item number item Possible answers e g labels for radiobutton Project EuroPa Country Germany Welcome Help Logout euroPa Date 13 03 2003 14 43 Center Test Berlin 1 r Sebastian W ltz Patient qwn582 Back D Current Drug Treatment For general help on completing this form see the first Help window at Current Form description p 7 Current treatment of parkinsonism Intermediate header Current treatment of parkinsonism Help Comment O yes no Query Levodopa preparations Question text Comment if YES specify below Query e null yes C no 1 L Dop null yes no Comment Ce C Query 2 L Dopa Slow Release null yes C no 3 L Dopa Soluble null yes C no O O O Answer lebel L Dopa Dual Hem null yes no 6 L Dopa Others null C yes C no vite acess ie Unit annotation 7 Date of initiation of Levodopa I I ETE Fig 3 Nomenclature and localisation of the various form elements on an eCRF This clearly shows that a content breakdown with a maximum of three layers can be portrayed within secuTrial forms The location of the specified elements in the HTML form is shown in the above figure 1 4 Reports and statistics To obtain an overview of the medical data which have already been captured entrie
94. cter format Ex QSEVLINT yes Evaluation Interval Char perm Timing Variables ample P2M to represent a period of the past 2 months as the evaluation interval for a question from a questionnaire such as SF 36 QSSTAT yes Completion Status Char perm Record Qualifier Used to indicate when a question about the occurrence of a pre Variable Prefix Variable label Type Core Role Description specified intervention was not answered Should be null or have a v alue of NOT DONE QSREASND yes Reason Not Done Char perm Record Qualifier Reason not done Used in conjunction with STAT when value is NOT DONE Short character value for TEST used as a column name when Short Name of Measurement converting a dataset from a vertical format to a horizontal format GOT ES EDT es Test or Examination Ghar 1189 MOple Th e short value can be up to 8 characters Examples PLAT SYS BP RRMIN EYEEXAM QSTEST s Name of Measurement Test or Char REQ Synonym Qualifier of Long name For TESTCD Examples Platelet Systolic Blood y Examination P TESTCD Pressure Summary Min RR Duration Eye Examination Result or Finding in Original se Result of the measurement or finding as originally received or col QSORRES yes Units Char exp Result Qualifier lected Examples 120 lt 1 POS QSORRESU yes Original Units Char perm ete AN of Unit for ORRES Examples IN LB kg L Contains the result value for all f
95. ctually the same value This may make evalu ation unnecessarily difficult Format check The input permits a maximum of 150 characters whose format is not checked Before a new entry is created a check is carried out to determine whether the input value already exists and this is then selected Consistency check Can be created in IASStandardGroup ASUnitGroup and ASHorizontalUnitGroup Productive Cannot be changed ASAlternateStandardGroup lASHorizontalGroup Lookup Table not extendable In the case of a lookup field values from a database lookup table are offered to the user in a drop down list This list is edited in the FormBuilder It is created as a Imnp table As in the case of pop up items the contents are saved as references The advantage of lookup tables in comparison with pop up items is that they can be interlinked Pet lt Please choose gt y Family pet Fig 43 Example of the view of a lookup table not extendable The datum Family pet is read out from the Unit format field Format check Not necessary Consistency check Can be created in ASStandardGroup lASAlternateStandardGroup lASHorizontalGroup IAS UnitGroup ASHorizontalUnitGroup ASCombinedSelection ASHorizCombinedSelection and ASMultipleSelection Non productive Cannot be changed to ASCombinedSelection ASHorizCombinedSelection or ASMultipleSelection Productive Cannot be
96. d Predicate Right table d Right column cvpid Right constant compare value o Remove 4 Left table E Left column mnpdid Predicate Right table m Right column mnpdid Right constant compare value I Remove _ New condition Highlighted rows New highlighting SOL SELECT p pseudonym V1 to_char mnpdate yyyy mm dd V2 case when isformcomplete d completionstatus 1 then Yes else No end V3 value_to_date m birthdate DD MM YYYY V4 value_to_label null mnpprobpersdata gender m gender V5 FROM iasdevadm patient p devprob probdocument d devprob mnpprobpersdata m devprob probcasenode devprob probcasevisitplan WHERE p pid DEVPROB probcasenode pid AND DEVPROB probcasenode cnid DEVPROB probcasevisitplan cnid AND DEVPROB probcasevisitplan cvpid d cvpid AND d mnpdid m mnpdid Fig 55 Lower part of the editing page of the SQL report from Fig 52 with specification of the table joins and the emerging SELECT statement DB functions DB functions which encapsulate a higher SELECT statement complexity or convert values into a legible form are often required here The usual Oracle or the following secuTrial functions can be used as functions BOOLEAN_TO_LABEL value yes no For check box items If the check box is clicked value 1 the text specified in Yes is fed back otherwise No VALUE_TO_DATE value format For date or time items The v
97. d with lt br gt at the end of the line Attention Contrary to the rule a break must never be closed lt br gt Paragraph Alternatively enclosed paragraphs can be identified with a lt p gt before and a lt p gt after the paragraph lt p gt lt is best to compare the result in the preview at an early stage lt p gt References References to static sites outside of secuTrial can be inserted using the following specification lt a href http www example com class underline gt Reference text lt a gt Specifying class is optional References are never portrayed underscored by the secuTrial standard design if you would like to insert the classic underscore here this can be achieved using the above specification Important Example The FormBuilder is used to create the form description for the DataCapture This not only enables the creation of the design and the assignment to the database fields data input can be checked using an extensive and complex set of rules This leads to a significant improvement in data quality However the diverse options for determining rules can also lead to undesired effects if these are not configured correctly The intention of this document is therefore to attempt to describe the effects of the individual rules in greater detail Rules can be subdivided according to various aspects both according to the necessity of conditions and also according to their effects The rules
98. dard format or in standard units STRESC sho uld store all results or findings in character format if results are numeric they should also be stored in numeric format in S TRESN For example if various tests have results NONE NEG and NEGATIVE in ORRES and these results effect ively have the same meaning they could be represented in standard format in STRESC as NEGATIVE PCEVLINT yes Evaluation Interval Char perm Timing Variables Evaluation interval associated with an observation such as a find ing TESTCD represented in ISO 8601 character format Ex ample P2M to represent a period of the past 2 months as the evaluation interval for a question from a questionnaire such as SF 36 PCDRVFL yes Derived Flag Char perm Record Qualifier Used to indicate a derived record e g a record that represents the average of other records such as a computed baseline Should be Y or null PCREASND yes Reason Not Done Char perm Record Qualifier Reason not done Used in conjunction with STAT when value is NOT DONE PCTPT yes Planned Time Point Name Char perm Timing Variables Text description of time when a measurement or observation should be taken as defined in the protocol This may be represen ted as an elapsed time relative to a fixed reference point such as time of last dose See TPTNUM and TPTREF PCSCAT yes Subcategory Char
99. depends on whether a date is specified and the current form is included Visit plan closed is cancelled again No In a casenode form this rule has no effect in a visit form this depends on whether a date is specified and the current form is included The intention of this is to cancel freezes which have been created due to the contrary rule see rule Freeze following forms if again The form status in the tpxdocument is reset to Editable Manually frozen forms remain manually frozen Caution Caution Caution Usage Visit or casenode forms withdraw the premature cancelling of data capture Caution with the combination with Freeze following forms The rules do not cancel each other but are both executed Freeze following forms if Can be applied to Condition Type Check Form status Casenode status Error message Effect Usage All item components except DB Dummy Layout Dummy and all calculable items without entry Score Date Interval Date section Depending on field type select date field as cut off date only the 1st condition is evaluated Action Saving revalidation Review status SysFreeze no effect in the casenode form in a visit form this depends on whether a date is specified and the current form is included Visit plan closed No In a casenode form this rule has no effect on the form itself in a visit form this depends on whether a date is specif
100. displayed in a separate window The validation report only lists entries for which the current participant has at least reading rights for the main form and if the form is also visible not hidden in DataCapture The report is displayed page by page in the DataCapture configuration in the FormBuilder default 100 rows per page and each error message is listed in a separate row The following information can be displayed The display can be selected via the options at the top of the page Patient pseudonym by project configuration and role rights Centre Visit AE visit or adverse event label Form Table Completion status Form status review freeze Date of the error message Version of the project at the time of validation Item Column Query status of the validation message item Value of the item Message Rule brief description at the time of validation Type type of error message for example rule error rule confirmation The report can be sorted and filtered by the majority of the displayed information The selected method of sorting is indicated by a small arrow next to column name The report can be downloaded as an Excel file All of the filtered entries in the report are listed in a table not divided into pages If the reports consists of more than 10 000 lines the reports will be split up into multiple table sheets with 10 000 lines per sheet T
101. ditions is immediatly done during data entry if the conditions have been defined over the current form items No server contact is ne cessary for this as the evaluation is implemented in Javascript and done directly in the Browser For this rule evaluation extensible Javascript functions have been implemented If you want to use own Javascript function you have to ensure that this functionality is not impaired This particulary re gards to the overwriting of any Javascript event handler Calculation of the form completion status Hide when Ignore for completion status Ignore for completion status if Input impossible if Input only possible if Input required or ignore completion status if If these rules are fulfilled or an entry is prevented by these rules the respective items won t be con sidered for the calculation of the completion status Value range check Input impossible if Input required Input required if Input only possible if Limit reached if Limit value range if As long as these rules are not fulfilled the form cannot be saved This check can only be bypassed using the Check data check box which can be configured for each project The form is then saved with the additional completion status With errors The Confirm input rule is a special case here If this rule is fulfilled the form can still be saved after displayin
102. e This is not comparable with the explicit specification of No or False This leads to complications particularly in the case of radiobuttons and check boxes if the input is to be compelled or prevented IASCheckBoxes are programmed in such a way that they convert an unclicked status into a NULL A rule which is intended to state that a check box should be answered actively with No is not therefore possible The reset option is available to enable resetting to NULL in the case of radiobuttons The standard label of the NULL option is not applicable specified via the LanguageBundle However a deviating label can also be specified for each item 3 5 Compare value text format The compare with value Text format can be selected in the FormBuilder to create conditions for text items When completing the form only the text which corresponds or does not correspond depending on the condition definition to the defined format can be input The TEST button is used to open a pop up in which you can test whether the text format which you have configured meets your requirements The question mark opens an overview of the different configuration options Sequence position 10 Error message wrong format Parameter is read from own item C this item Compare or Assign Operator equal value X Compare Value text format x Compare Value a format LLLLL Test Fig 51 Example of the condi
103. e should sto re all numeric test results or findings Variable Qualifier of Standardized units used for STRESC and STRESN Example LBSTRESU yes Standard Units Char exp STRESC and STRESN mol L Normal Range Lower Lim Variable Qualifier of Lower end of normal range or reference range for standardized LBSTNRLO yes it Standard Units Num exp STRESC and STRESN results e g STRESC STRESN represented in standardized units STRESU Description of toxicity quantified by TOXGR such as NCI CTCAE LBTOX es Toxicit Char Srm Variable Qualifier of TOX Short Name Examples HYPERCALCEMIA HYPOCALCEMIA y y p GR Sponsor should specify which scale and version is used in the Sponsor Comments column of the Define xml document Records toxicity grade using a standard toxicity scale such as the i qe NCI CTCAE Sponsor should specify which scale and version is EE TOXG Yes excl Orage A Repor auaina used in the Sponsor Comments column of the Define xml docu ment EN x Upper end of normal range or reference range for standardized LESTNRA yes Noma Range Upper Lim ium jexp Y ailable Qualifier ot results e g STRESC STRESN represented in standardized it Standard Units STRESC and STRESN units STRESU i in Normal range or reference range for results stored in STRESC LBSTNRC yes oral mangeron Character Char perm Mavlable Gualiigndt that are character in ordinal or categorical scale Example Negati Results STRESC ve
104. e C selectable Column is O simple value pseudonym document ID Y Title Patient 0 Variable name Pl Ordered by ASC x Remove Highlighted rows Fig 56 Free text field for entering the SQL statement and separate definition of the displayed columns 7 For this SQL report type it is likewise possible to define row highlighting based on the variable name of the column description 5 3 Single field A single form value for all visits is portrayed in this report If the selected form is not displayed in all visits this visit is skipped or omitted in the portrayal 31 08 2010 19 34 CEST Print E e Dipl biol Susanne Schneider Secu ria Study 1 31 08 2010 19 34 11 CEST Excel Weight Y Centre A No patients included Y Centre B Pat1D 1 visit 2 visit ick371 A I pxe146 os 75 4 kg xkx764 76 0 kg xyx219 B 63 8 kg 70 0 kg feu zpu285 Fig 57 Example of the view of a single field report in the DataCapture in this case the portrayal of the patients weight Numerical fields offer the additional option of particularly emphasising values above or below a spe cified limit value In the case of fields with a defined unit a check box can be used to select whether these are to be displayed in the report No 8 Name Weight Type CSOL e Single field Single field per visit Status Queries details Icon display Image forms M Show reports of all Centre EF di
105. e case of date specifica tions it must be noted that sorting is carried out on a text basis The value Saved is read out from the saving time stamp here whilst the value Birthdate represents a form item If a form as in this case is available in several visits a patient may also be listed several times in this report type The parts of a SELECT statement are defined individually for an SQL report whereby the basic framework is specified by secuTrial Nesting is therefore only possible to a limited extent The fol lowing parts can be defined SELECT columns WHERE condition GROUP BY grouping HAVING group limitation The statement is executed in the participant administration scheme of the relevant current custom er Access is therefore only possible to the tables for which the corresponding DB user has read rights In the secuTrial database this includes all tables for the project belonging to this customer from the corresponding DB area the project setup tables SRTSetup setadm and the general look up tables SRTLibrary libadm This means that only the test project tables can be accessed in the setup DataCapture and only the productive project tables in the productive DataCapture The test area is always used in the FormBuilder the statement and execution in the DataCapture are then adapted to the current area To do this the corresponding user is automatically added in front of the referenced tables
106. e for TRT TERM or ORRES is modified for coding MEMO yes Mediied Mane Chal Perm eGo op purposes then the modified text is placed here Variable Prefix Variable label Type Core Role Description MHREASND yes Reason Not Done Char perm Record Qualifier Reason not done Used in conjunction with STAT when value is NOT DONE Used to indicate when a question about the occurrence of a pre MHSTAT yes Completion Status Char perm Record Qualifier specified intervention was not answered Should be null or have a v alue of NOT DONE Used to record whether a pre specified intervention occurred MHOCCUR yes Occurrence Char perm Record Qualifier when information about the occurrence of a specific intervention is s olicited a a Used when a specific intervention is pre specified on a CRF Val MHPRESP yes Pre specified Char perm Record Qualifier ues should be Y or null MHSCAT yes Subcategory Char perm Grouping Qualifier Used to define a further categorization of CAT values Description or date time in ISO 8601 character format of the MHENTPT yes End Reference Time Point Char perm Timing Variables sponsor defined reference point referred to by ENRTPT Ex amples 2 003 12 25 or VISIT 2 Standardized or dictionary derived name of the topic variable Standardized Treatment TRT or the modified topic variable MODIFY if applicable Eq MHDECOD yes Name Char perm Synonym Qualifier o
107. e for all findings copied or derived from ORRES in a standard format or in standard units STRESC sho uld store all results or findings in character format if results are nu Result or Finding in Standard meric they should also be stored in numeric format in S TRESN VOS TRESS Yes Format Char exp Result Qualifier For example if various tests have results NONE NEG and NEGATIVE in ORRES and these results effectively have the same meaning they could be represented in standard format in STRESC as NEGATIVE f PEON Used for continuous or numeric results or findings in standard VSSTRESN yes Aumene Besulb ringing y Num exp Result Qualifier format copied in numeric format from STRESC STRESN Standard Units qe should sto re all numeric test results or findings VSSTRESU yes Standard Units Char req Variable Qualifier of Standardized units used for STRESC and STRESN Example STRESC and STRESN mol L Variable Prefix Variable label Type Core Role Description VSBLFL yes Baseline Flag Char exp Record Qualifier Indicator used to identify a baseline value Should be Y or null Used to indicate a derived record e g a record that represents VSDRVFL yes Derived Flag Char perm Record Qualifier the average of other records such as a computed baseline Shoul d be Y or null VSDTC yes Date Time of Collection Char exp Timing Variables Collection date and t
108. e of the field defined in the condition is taken over into the current field Sensible for taking over information with a high probability of remaining identical from previous visits e g date of birth sex With the assignment operator take value add value a value is specified which will then be added to the adopted value in the form All forms as a convenience method Value take over only ever takes place once When saving the initial form for a second time the value in the take over form is not overwritten It is also additionally possible to manually change the taken over value This may lead to the fact that the values no longer correspond Take value if same visit day from Can be applied to Condition Type Check Form status Casenode status Error message Effect Usage Limit value range if Can be applied to Condition Type Check Form status Casenode status Error message Effect Usage 3 4 Scores All item components except DB Dummy Layout Dummy and all calculable items without entry Score Date Interval Date section Specification of the item as a parameter is omitted Action Initialisation of unsaved forms or new repetition groups No effect No effect Error message if adopted value Wert added value does not match the defined item format and can not be displayed e g value 10 in a 1 0 number field The value of the field defined in the condition is t
109. e unclear IASHorizCombinedSelection Comment Query Colour lt Please choose gt y Pet Persian Fig 18 Example of the view of an IASHorizontalCombinedSelection with selection of the upper lookup table left The middle table then contains only the possible entries for selection The right lookup table does not yet contain any entries These are only offered following selection of the middle lookup table z Normally the items are distributed evenly according to their number over the width of the page with 3 items each item therefore takes up 1 3 of the width of the page A Flexible column width can be configured instead the items are then arranged directly behind each other and are not distributed over the width of the page Consistency check Non productive Can be changed to lASHeadline items are deleted IASCombinedSelection IASMultipleSelection ASStandardGroup lASAlternateStandardGroup or lASHorizontalGroup Productive Can be changed to lASCombinedSelection IASMultipleSelection ASStandard Group IASAlternateStandardGroup or ASHorizontalGroup Only lookup tables not extendable can be created After creating the first lookup table only the lookup tables hierarchically positioned below this can be selected TASUnitGroup The IASUnitGroup consists of at least two items whose types are firmly specified It is intended to be able to specify data on measured values in various previous
110. e view of a report on single fields per visit Three different fields have been selected for the first visit a single field for the other visits Visits or casenode forms can be selected Several fields can be defined for each visit Exceeded lim it values can also be emphasised for numerical values in this report type see Single field section The sequence of the items can be explicitly specified Use the SORT VIEW button to carry out changes to the sorting Your sorting changes can be accepted in this way 5 5 Status The status information for all visit forms can be displayed via the visits There are different types of status Review ompletion status query and comments In the case of status reports the data are listed in separate tables sorted by centre To shorten the loading times the user can specify that the different centres are only to be displayed individually Only the list of patients in the first centre is then initially displayed the other centre can then be displayed via the If the participant is only in one centre the data from this centre are displayed immediately For status reports you can select whether the report is sorted by visit type or chronologically For example it may be that the used patient visits differ from each other in different treatment arms and displaying a combined overview would be difficult in the report When sorting by visit type the treatment arms are listed separately Wh
111. ected as the type It is also not possible that the HELP COMMENT and Query buttons do not appear next to an lASHeadline Attention Checkbox Matrix Comment Query column 1 Row1 OT Row2 OT Headline Horizontal Group Comment Radiobutton Reset Radiobutton Popup Group Query Cred green black not C red green black O lt Please choose gt applicable Fig 6 Example of the view of an ASHeadline between two other types If another type is converted into an lASHeadline all items contained therein are deleted without warning Consistency check Non productive productive Can be changed to all other types can always be deleted No items can be created IASHorizontalGroup This type is a standard type comparable with the ASStandardGroup but arranges the items hori zontally next to each other and not beneath each other It is recommended when the texts and fields are very short e g small radiobutton item and a date item and you wish to save space less scrolling A HorizontalGroup can be used good subforms when many repetitions are expected 2 lASHorizontalGroup Comment This is the first description text The formatting is predefined here Query This is the second description text The text here can be formatted with HTML tags e g the text can be set bold or italic a Horizontal Radiobutton with reset option b Textfield not applicable yes Cno unit Fig 7 Example of the
112. ed situations The purpose of this procedure is to achieve a certain distribution within a block and within the entire patient set The advantage is that randomiza tion lists can be created in advance Procedures 4 and 5 differ in the number of blocks to be specified within a list and are used in un stratified situations If a new patient is being randomized that patient will be assigned to the next available list element treatment arm of the current block To avoid predictability it is therefore advis able to select different block sizes procedure 5 also permits random generation of block sizes Procedure 6 is a stratified situation A randomization list is created for each combination of the strati fication factor levels of the patients When a new patient is randomized the list which corresponds to the patient s stratification factors will be selected first Next the patient is assigned to the next avail able list element treatment arm as in method 4 and 5 If there is a large number of stratification factor level combinations the risk arises that only a few patients from certain lists will be processed which can lead to an increased risk of incomplete lists and unbalanced relationships within the treat ment arm Simple Randomization 7 is simplest mode of randomization Patients are randomly assigned to a treatment arm By selecting external randomization 8 it is possible to also use any additional algorithms of your cho
113. eeeeeeeeeeeeeaes 119 IE Inclusion Exclusion Criteria Not Met Findings General Observation Class 120 LB Laboratory Test Results Findings General Observation Class 0 ccccceeeeeeereeeeeeees 121 MB Microbiology Specimen Findings General Observation Class oooocnnninnccncnnnicaccccnnnnnn 123 MH Medical History Events General Observation Class c ccceceeceeeeeeeenteeeeeeeeenneeeeeees 125 MS Microbiology Susceptibility Findings General Observation Class 0 eeee 127 PC Pharmacokinetic Concentrations Findings General Observation ClasS 128 PE Physical Examination Findings General Observation Class 0 ecteee eee 130 PP Pharmacokinetic Parameters Findings General Observation Class cceeeeee 131 QS Questionnaires Findings General Observation ClasS ooooooccccccinnnnncconnoncnccccnnccnnnnons 132 SC Subject Characteristics Findings General Observation Class 134 SU Substance Use Interventions General Observation ClasSS oooononncccnncnccnnccinnncnnncnnns VS Vital Signs Findings General Observation Class Since 4 8 In the current version the following new function has been introduced New rule Input required or ignore completion status if New rule Display form if Multiple query messages 1 1 The FormEngine translator between database and HTML form n secuTrial only generates forms eCRF d
114. efined by a discrete starting point and a discrete ending point represented by RFS TDTC and RFENDTC in Demographics Identifies the start of the observation as being before during or Start Relative to Reference after the sponsor defined reference period The sponsor define d CESTRF yes Period Char perm Timing Variables reference period is a continuous period of time defined by a dis crete starting point and a discrete ending point represented by RF STDTC and RFENDTC in Demographics Study Day of Visit Collec os Actual study day of visit collection exam expressed in integer days GEDY YES tion Exam NUS yoni Ma Vanaples relative to the sponsor defined RFSTDTC in Demographics CEENDTC yes la Date Time of Observa Char perm Timing Variables len of the observation represented in ISO 8601 character CESTDTC yes el Date Time of Observa Char perm Timing Variables ees of an observation represented in ISO 8601 character A i mar Collection date and time of an observation represented in ISO 8601 CEDTC yes Date Time of Collection Char perm Timing Variables character t rmiat CESEV yes Severity Intensity Char perm Record Qualifier The severity or intensity of the event Examples MILD MODER Variable Prefix Variable label Type Core Role Description ATE SEVERE Body System or Organ Body system or system organ class from a standard hierarchy e g CEBODSYS yes e y 9 Char perm
115. egory Char req Grouping Qualifier Used to define a category of topic variable values Short character value for TEST used as a column name when Short Name of Measurement converting a dataset from a vertical format to a horizontal format MOTESTEO yes Test or Examination Char red Topig Th e short value can be up to 8 characters Examples PLAT SYSBP RRMIN EYEEXAM Text description of time when a measurement or observation MSTPT yes Planned Time Point Name Char perm Timing Variables should be taken as defined n the protocol This may be reprgsenz ted as an elapsed time relative to a fixed reference point such as time of last dose See TPTNUM and TPTREF MSREASND yes Reason Not Done Char perm Record Qualifier E dora sedi CONUN OVR TAE yale MSTPTNUM yes Planned Time Point Number Num perm Timing Variables Numeric version of planned time point used in sorting Used to indicate when a question about the occurrence of a pre MSSTAT yes Completion Status Char perm Record Qualifier specified intervention was not answered Should be null or have a v alue of NOT DONE MSELTM yes Planned Elapsed Time from Char perm Timing Variables Planned Elapsed time in ISO 8601 character format relative to a planned fixed reference TPTREF such as Previous Dose or Time Point Ref Pre vious Meal This variable is useful where there are repetitive measures Not a clock time or a date time variable but an in
116. elled here for purposes of clarity Format check Not necessary as no user inputs or selection take place Consistency check Can be created in ASStandardGroup IASAlternateStandardGroup IASHorizontalGroup IAS UnitGroup ASHorizUnitGroup Non productive Can be changed to all item types which are permitted in the question Productive Cannot be changed but deleted Image This component consists of a display area for the image file symbol whose size can be defined from 48x48 to 2000x2000 pixels A link button for uploading files is available The file last saved is portrayed beneath the display area with original file names and information of file and image size Picture Upload an image Fig 47 View of an image component in the DataCapture before an image was uploaded Arbitrary files can be uploaded in the image component If this involves standard image formats e g jpg png gif these are stored in triplicate on the server Original file can be downloaded again in this form Web view for displaying in the form scaled to the size defined for the item Thumbnail for displaying in the AuditTrail and as a form icon size 48x48 pixels All other formats are stored only as original files on the server and are symbolised by an icon in the other locations An applet is available for both uploading and displaying when processing DICOM images On up loading the personal data in the D
117. en sorting reports chronologically the patient visits are listed in the order of the current pa tient For projects using CPV reports can be sorted chronologically or by visit type Close Date 31 08 2010 19 53 CEST Print 2 p articipant Dipl biol Susanne Schneider secu ria Project Study1 31 08 2010 19 53 38 CEST Excel Completion status Y Centre A No patients included Y Centre B Pat ID 1 visit 2 visit 3 visit Patient status Adverse Event ick371 A Fig 60 Example of the view of a status report on the completion status this is made clear here using coloured style sheets light blue empty medium blue partly filled midnight blue complete On creation of a new status report completion status query comments and review all status checks possible for the selected status field are already created in the correct sequence Review Here all forms which can be saved must be reviewed again so that the entire visit has the status Review An individual review is not displayed here The various statuses can be marked via text specifications and the selection of a style sheet A preview clarifies the effect of the style sheet in this case s sec ulria ate 31 08 2010 19 56 CEST Participant Dipl biol Susanne Schneider Logout Welcome gt Project Project Study 1 31 08 2010 19 56 00 CEST PROB Registry No 2 Development Edit reports Study 1 9 Copy No Report Status Type Delete f
118. ention observation usually the verbatim EXTRT yes Name of Treatment Char req Topic name of the treatment drug medicine or therapy given during th e dosing interval for the observation EXDOSE yes Dose Num exp Record Qualifier ay of TRT given Not populated when DOSTXT is popu Planned Elapsed time in ISO 8601 character format relative to a Planned Elapsed Time from planned fixed reference TPTREF such as Previous Dose or EXELTM yes Aap Char perm Timing Variables Pre vious Meal This variable is useful where there are repetitive Time Point Ref E measures Not a clock time or a date time variable but an interva represented as ISO duration Text description of time when a measurement or observation EXTPT yes Planned Time Point Name Char perm Timing Variables should be taken as defined m the protocol This may be rEPrTESen ted as an elapsed time relative to a fixed reference point such as time of last dose See TPTNUM and TPTREF Collected duration of an event intervention or finding represented EXDUR yes Duration Char perm Timing Variables in ISO 8601 character format Used only if collected on the C RF and not derived EXSTDTC yes Start Date Time of Observa Char exp Timing Variables Start date time of an observation represented in ISO 8601 charac tion ter format IE Inclusion Exclusion Criteria Not Met Findings General Observation Class Variable Prefix Variable label Type Core Role Description IECAT yes Category Cha
119. equally frequently 1 1 Possible only the patients from the same stratum are used for determin ing the randomized patients of the last incomplete block Only for blinding or with centre assignment This algorithm evaluates all of the previously randomized patients from the same stratum for the ran domization of the current patient The distribution of the groups can be configured Optionally the maximum number of patients to be randomized in the selection can be limited The ratio of the vari ous randomization groups to each other must remain within this number Probability Randomization groups Weighting of the groups Stratification Randomization list 3 Variance minimization Probability of 0 1 with which the randomization group determined by the algorithm will not be selected With this random element the predictabil ity is minimized At least 2 Entry possible as ratio Necessary All randomized patients from all strata are required to de termine the randomization Only for blinding or with centre assignment 7 This algorithm evaluates all of the previously randomized patients from the same stratum for the ran domization of the current patient The distribution of the groups can be configured The maximum number of patients to be randomized can be optionally limited in the selection The ratio of the vari ous randomization groups to each other must remain within this number Probability Probability of 0 1 with w
120. eration in the relevant statistics If the statistics include the evaluation of form datasets only compared datasets will be evaluated when using the DDE function All other datasets including previously entered datasets are treated as Not saved 6 1 Chart type The type of portrayal can be selected via a drop down list on configuration of the statistics The graphics types each possible for the number of information dimensions are offered The pie chart can only be used for two parameters whilst the staggered bar charts are only used for three parameters Line chart Patients over time Patients according centres over time 11 6 10 07 2010 08 2010 09 2010 07 2010 08 2010 09 2010 M Patients M Benin W Hamburg W M nchen 01 09 2010 15 06 01 09 2010 15 06 Fig 67 Examples of the view of statistics as a line chart for two parameters left and three para meters right Bar chart 3D Patients according centres Patients according centres el 6 5 5 4 all a AN 2 2 ee e E gt 5 z gt 5 E E z 3 z 3 E Patients M Patients 01 09 2010 15 06 01 09 2010 15 11 Fig 68 Examples of the view of statistics as a simple bar chart and a 3D bar chart for two para meters Patients according centres over time 1 o El E a Patients according centres over time 2 6 w 5 4 3 o l l J N y 1
121. ervation Class Variable Prefix Variable label Type Core Role Description f na Defines the type of specimen used for a measurement Ex PCSPEC yes Specimen Material Type Char perm Record Qualifier amples SERUM PLASMA URINE PCORRESU yes Original Units Char exp eee ne of Unit for ORRES Examples IN LB kg L PCSPCCND yes Specimen Condition Char perm Record Qualifier Defines the condition of the specimen Example CLOUDY a Variable Qualifier of Standardized units used for STRESC and STRESN Example PCSTRESU yes Standard Units Char exp STRESC and STRESN mol L Pa en Method of the test or examination Examples EIA Enzyme Im PCMETHOD yes Method of Test or Examination Char perm Record Qualifier munoassay ELECTROPHORESIS DIPSTICK PCSTRESN yes Numeric Result Finding in Num exp Result Qualifier Used for continuous or numeric results or findings in standard Standard Units format copied in numeric format from STRESC STRESN Variable Prefix Variable label Type Core Role Description should sto re all numeric test results or findings PCFAST yes Fasting Status Char perm Record Qualifier Indicator used to identify fasting status Valid values include Y N U or null if not relevant PCSTRESC yes Result or Finding in Standard Format Char exp Result Qualifier Contains the result value for all findings copied or derived from ORRES in a stan
122. es not match the to be ignored value This calculation can be used e g to determine the mean value Functions such as Ignore following value on calculation or Only calculate with a maximum of so many uncounted values see Calculate score from can also be used in the case of this score The calculated value e g mean value can also be multiplied by an arbitrary factor This multiplica tion is used e g to portray estimated sums if not all values to be included for a sum can be specified and the sum of all required values is still to be calculated result result number of sensible answers factor SumA 1 SumB 2 Sum C NULL Result 4 5 Result sum of A and B 2 sensible answers 3 Calculate score function from The function score which offers even more options is additionally available to achieve even greater flexibility when calculating scores A multiplication factor if none is specified multiplication by 1 is carried out and a function can additionally be selected for each parameter The functions implemented are simple multiplication without function selection a x item value natural logarithm a x In item value power function a x item valueexponent exponential function a x basisitem value natural exponential funktion a x eltem value If you then have e g the following function for calculating the body surface in m from the height in cm and weight in kg surface weight 425 x height0
123. estions from other forms and or other visits can be added in the mes sages Which forms and sources are available to choose from depends on the message form and the selec ted form for the question which is to be added In the case of visit forms both relative visits similar to the definition of rule conditions and defined visits from the project visit plan can be selected If the visit defined here has been created multiple times in a patient the first visit of this type will be used for the message You can mark in addition the resending of messages through an additional template text which can be entered accordingly This information will then be displayed before the message if the message was previously triggered with the current settings in the audit trail of the form This indicates that the result has already been reported e g in the case of an automatic Adverse Event message Content Email format HTML O Adverse Event occured This event has already been reported Please check for red marked changes q Ladies and gentlemen lt br gt lt br gt please inspect the included information Note for multiple dispatch End of message Best regards lt br gt lt br gt Your Study Team Dispatched form questions Markup of changed form values FO 0 erapie Remove Form questions lt Please choose gt X Add Fig 76 Configuration of marked up changes in the message template If the option Markup of
124. f TRT uivalent to the generic drug name in WHO Drug or a term in SNOMED ICDS9 or other published or sponsor defined dictionar les MHCAT yes Category Char perm Grouping Qualifier Used to define a category of topic variable values End Relative to Reference Identifies the end of the observation as being before or after the MHENRTPT yes Time Point Char perm Timing Variables sponsor defined reference time point defined by variable ENTP T Identifies the end of the observation as being before during or End Relative to Reference after the sponsor defined reference period The sponsor defined r MHENRF yes Period Char perm Timing Variables eference period is a continuous period of time defined by a dis crete starting point and a discrete ending point represented by RFS TDTC and RFENDTC in Demographics MHENDTC yes End Date Time of Observa Char perm Timing Variables End date time of the observation represented in ISO 8601 charac tion ter format MHSTDTC yes Start Date Time of Observa Char perm Timing Variables Start date time of an observation represented in ISO 8601 charac tion ter format MHDTC yes Date Time of Collection Char perm Timing Variables Collection date and time of an observation represented in ISO 8601 character format MS Microbiology Susceptibility Findings General Observation Class Variable Prefix Variable label Type Core Role De
125. f a date field Date DD MM YYYY Format check Only numbers from permissible calendar ranges may be input whereby the smaller fields can be left empty In the case of a day month year field only specifying the year and the month and omitting the day is permissible Specifying the day and year and omitting the month is not permitted Consistency check Can be created in lASStandardGroup lASAlternateStandardGroup lASHorizontalGroup ASUnitGroup and IASHorizontalUnitGroup Note Non productive as long as an item has not been set to productive mode it is possible to change the component type between Date and checked Date even if the item has been assigned rules Productive Can be changed to date or checked date in which the information content is at least as large as in the productive version l e Date MM YYYY can still be changed to Checked date DD MM YYYY but no longer to Checked date YY YY Checked Time Identical to the normal time field the difference involves the check of completion Operates in line with the checked date Format check See checked date Consistency check Can be created in lASStandardGroup lASAlternateStandardGroup lASHorizontalGroup ASUnitGroup and ASHorizontalUnitGroup Non productive as long as an item has not been set to productive it is possible to change the component type between Time and checked Time components even if the item has been assi
126. fied parameters from the selected fields This rule is exclusively intended for score fields The score is calculated on request button click and on saving the form In the case of groups of labels the multiplication factors are used for calculation purposes if these are set Otherwise the DB value is used See Scores section for the precise function For calculating sum values from other questions Scores are calculated on score fields with rules which usually consist of several conditions When defining multiple score rules on an item they will be calculated in the defined sequence and only with fulfilled preconditions The value calculated last will then be saved event if All item components except DB Dummy Layout Dummy and all calculable items without entry Score Date Interval Date section in an adverse event form Depending on field type Action Saving revalidation No effect No effect No AdverseE vent status is set to Is SAE The first available SAE form is offered opened as the subsequent form AE forms for creating an SAE form for converting from AE to SAE via rules Close adverse event if Can be applied to All item components except DB Dummy Layout Dummy and all calculable items without entry Score Date Interval Date section in a adverse event form Note Condition Type Check Form status Casenode status Error message Effect Usage Depending on type Action Sav
127. for the project administration and project set up tables The description corresponds with the documentation contained in the project dossier and the DB documentation that can be downloaded in the CustomerAdminTool By clicking on a table or column name you can append the name to the end of the statement gt deun5 Form and meta tables of patient data Y b4975devadm Participant administration and general patient information Table name Column name Data type Description gt ADMINLOG Log table for the A4dminToo An unitary incremental audit trail for all objects is written gt ADMIHLOGOBJECT Each single database object changed from within the AdminTool is logged here with it s changes Some values Passwords medical data are masked thereby gt ATCENTRE Information about a centre 4 centre could represent a clinic a topically work group or a practice The main information is the name 4 centre is the basic access unit to the patient pool All members of a centres have the same according role rights to all patients in the centre Prior to each save a copy of the original data is stored in this table Y CENTRE Information about a centre A centre could represent a clinic a topically work group or a practice The main information is the name 4 centre is the basic access unit to the patient pool All members of a centres have the same according role rights to all patients in the centre ADMINISTRATIVE NUMBER Flag if set t
128. g the error message by saving again In this case the completion status is always addition ally marked With warnings This rule relaxation can additionally be activated for the following rules by means of the ONLY AS CONFIRMATION check box Defined actions Hide when Show treatment arm if Freeze casenode if Delete casenode if Display form if Take date from Confirm input if Free following forms if Freeze following forms if Free single form if Freeze single form if Generate message if Calculate normed score from Delete patient pseudonyms if Patient deceased if Deactivate patient if Freeze patient if Delete patient if Open serious adverse event if Calculate score function from Close adverse event if Open adverse event if Take value if same visit day from Take value from If these rules are fulfilled a defined action is triggered Form initialisation Take date from Take value from Take value if same visit day from These rules are only evaluated during form initialisation and only when the form is opened for the first time and has not yet been saved These rules are used to enhance comfort The participant no longer has to input certain data manu ally On the other hand however these rules are
129. ge used For empty visit messages you can additionally configure the time period for the messages To do this enter the start and end time of the message and the interval in days with regard to the planned visit date When configuring messages for the trigger Empty visits you can define multiple messages e g for different message time periods In this way different reminders can be sent before and after a planned visit date see fig 75 If a project uses the bundled message dispatch is therefore determined by the defined project mes sages Not bundled messages With the project messages another message can be defined for the trigger Patient created This message is not sent as a bundled message dispatch but immediately when a patient is created Message dispatch Notification at 5 internal title New notification Empty visit 1 day after to 2 days after Leere Visite 1 Tag nach Delete amp Empty visit 1 day before to O days after Leere Visite 1 Tag vor Delete Empty visit 2 days before to 1 day before Leere Visite 2 Tage vor Delete Query asked Query gestellt Delete SDV reset Nachricht bei SDV Delete Fig 75 Overview of all project messages on the project configuration page Bundled message dispatches are indicated with a clock icon 7 3 Form messages For all form and rule messages in addition to the general settings questions can be dispatched from the current form or qu
130. ges are carried out in all usages Unclear compilations may particularly arise with subsequently changing the DB value In the case of lists the ID is always specified as the last numerical value to identify the various individual labels Format check Not necessary Consistency check Can be created in ASStandardGroup lASAlternateStandardGroup lASHorizontalGroup IAS UnitGroup HorizontalUnitGroup IASVertRBMatrix and I ASHorizRBMatrix The group of labels is checked as regards the clarity of the assigned sequence DB values and texts distinction between capital and lower case letters The check for unambiguousness of the text are only made as a warning Non productive Cannot be changed in ASHorizRBMatrix or ASVertRBMatrix Productive Can be changed to vertical radiobutton and pop up Vertical Radiobutton Lieblingsfarbe O keine Angabe C blau C grin C rot Fig 29 Example of a vertical radiobutton with reset option The conditions which apply to the vertical radiobutton are the same as those for the horizontal radiobutton However the layout is vertical Pop up Certain questions in an eCRF may have a limited and previously defined selection of possible answers In this case space may be saved by arranging them in a pop up field so that the user merely has to select the correct answer from the list during data input In basic status only one answer can ever be selected otherwise an lASRepetit
131. gned rules Productive Can be changed to time or checked time in which the information content is at least as large as in the productive version l e Time HH MM can be changed to Checked time HH MM SS but no longer to Checked time MM SS Checked Date Identical to the normal date field the difference involves the check of completion The user cannot instantly distinguish between the simple date fields and the checked date time fields Format check The difference involves the check of completion In the case of a checked date all displayed fields must also be completed In contrast the relevant smaller fields e g omit month but specify year can be omitted in the case of a normal date field Checked date and normal date fields can only be compared via the set of rules if the date and or time format matches Consistency check Can be created in lASStandardGroup lASAlternateStandardGroup lASHorizontalGroup ASUnitGroup and lASHorizontalUnitGoup Non productive as long as an item has not been set to productive it is possible to change the component type between Date and checked Date even if the item has been assigned rules Productive Can be changed to date or checked date in which the information content is at least as large as in the productive version l e Date MM YYYY can still be changed to Checked date DD MM YYYY but no longer to Checked date YY YY Number The number
132. he centre will be ignored in the generation of reports and statistics O null normal centre 1 administrative centre AGNAME VARCHAR2 100 Unique name in whole setup of customer and area setup productive AIDPREFIX VARCHAR2 15 Project unique centre prefix for the additional patient ID AID if configured in project CID NUMBER Foreign key to B4975devadm COUNTRY CID CTRID NUMBER Primary key EMAIL VARCHAR2 100 Email address of person in charge LOCID NUMBER Foreign key to B4975devadm LOCATION LOCID MAXPATIENTS NUMBER If set the value limits the maximal possible number of patients in the centre PROJECTID NUMBER Foreign key to setadm PROJECT PROJECTID During creation the centre is assigned to a project This assignment can not be changed Fig 53 Excerpt from the database description of the project devioas0 and administration tables iasdevadm The database description is opened via the i icon Click on the table or column name in the pop up window to insert the table or column name from which the pop up was opened into the text field If the pop up for one of the elements was opened the pop up will close after the selection is made this is necessary because the corresponding text field is determined by opening the pop up As an additional report property you can set the number of simultaneously displayed rows in DataCapture If you make an entry here the result of the SELECT will be displayed page by page with t
133. he configured number of rows per page in DataCapture This setting should be used if a large number of results is expected It is possible to download SQL reports as MS Excel files In the file all of the displayed datasets will be listed taking into account any previously set dataset filters The number of datasets will be listed in the information at the beginning All of the datasets in the file will be listed below each other even if they are displayed page by page in the report Any highlighting of datasets will not be displayed in the Excel file No F Name sac Report Type esa c Single field Single field per visit Status Queries details C Icon display Image forms Style definition of the odd rows Please choose gt Please choose gt Preview rows even rows lt Please choose gt z Preview Columns select Please supply either a table column or a db function not both 1 Display Chidden shown I sortable M selectable Y Table patient amp Table alias b Column sedan e Title Pa O DB function D Variable name MOTTO Ordered by k Please choose gt Remove 2 Display C hidden shown M sortable I selectable Y Table odeme O Table alias o Column CO BD Title Saved O DB function to_charmnpdate wyymmedd O Variable name 2 OS Ordered by lt Please choose gt zj Remove B Display C hidden shown M sortable I selectable Y Table a
134. he description is to be defined according to the attributes of the previous SQL report A new attrib ute that can be entered in the description is whether a patient can be accessed via the column column includes one of the pseudonyms or a form column includes the document ID This report will also be automatically extended with the corresponding DB users in the table To limit the report to the centres of the current participant the place holder lt CENTRES gt can be used to ref erence all centre IDs of the current participant These will then be bundled as a set IDs listed in brackets e g 125 5 7 13 In FormBuilder all centres in the project are used instead of the centres of the current participant In the free text statement the parameter list of the function VALUE_TO_LABEL is also extended by the current project version To enable the statement to be checked for forbidden commands the window for checking the SQL status is only active once the report has been saved For this reason when saving an SQL report a message will be displayed only once that saving will reset the SQL status SELECT statement SELECT patient pseudonym P1 centre agname ZENTRUM FROM centre patient nScasenode WHERE patient pid n5casenode pid AND centre ctrid nScasenode ctrid AND centre ctrid IN lt CENTRES gt GROUP BY pseudonym agname Columns Y 10 _ Display O hidden shown O sortabl
135. he report can also be printed as displayed page by page Close 29 01 2013 14 35 CET Print j Dipl biol Susanne Schneider secu ria Example Study 29 01 2013 14 31 00 CET Excel Validation report 63 lines M O M M O D O O O E m E O M r M Patient Visit AE Form Message Type lt Please choose gt lt Please choose gt lt Please choose gt lt Please choose lt Please choose gt dhz086 1 Adverse Event Adverse Event Eingabe erforderlich rule error dhz086 2 Adverse Event Adverse Event Eingabe erforderlich rule error dhz086 1 visit DST Test Eingabe erforderlich rule error dsu877 2 visit DST Test Eingabe erforderlich rule error gnt320 1 visit Components Input required rule error gnt320 1 Adverse Event Adverse Event The description must be given if the event type is other rule error gnt320 1 Adverse Event Adverse Event Therapy must be specified if yes is ticked rule error gnt320 1 Adverse Event Adverse Event Input required rule error ige813 1 visit DST Test Eingabe erforderlich rule error ige813 2 visit Komponenten Eingabe erforderlich rule error ige813 2 visit ITM Test Form Bitte Angabe machen rule error Fig 66 Example of an validation report The form overview of the listed patients can be accessed via the patient details pseudonym centre The corresponding form can be directly accessed via the details for each validation mes sage e g form
136. hich the randomization group determined by the algorithm will not be selected With this random element the predictabil ity is minimized Randomization groups At least 2 Weighting of the groups Entry possible as ratio Stratification Necessary All randomized patients from all strata are required to de termine the randomization Randomization list Only for blinding or with centre assignment 4 Static unstratified single block randomization This algorithm is based on a two step procedure first a randomization list is generated which is then simply processed in sequence during the actual randomization For the distribution of the groups in the list various entries must be made The distribution is only guaranteed within the list Restriction restricted or unrestricted With a restricted list the entered ratio cor relates exactly With unrestricted lists small deviations are possible Group allocation by Accrual or Ratio see below Randomization groups At least 2 Weighting of the groups Accrual specification of the number of patients per group Ratio specification of the ratio of the groups to each other specification of the number of patients when generating the list in the AdminTool Stratification Not possible Randomization list Required created in the AdminTool 5 Static unstratified multi block randomization This algorithm is based on a two step procedure first a randomization list is gene
137. ice by importing lists accordingly 1 Extended stratified block without list secuTrial This is a block algorithm without a predefined list which guarantees an even distribution of the ran domization groups All previously randomized patients are taken into account if applicable only pa tients from the same stratum These patients are evaluated in the order of their randomization to de termine the sequence of the previous random groups The number of possible randomizations is only restricted if the randomization is carried out in blinded form or with the help of a centre assignment Fig 44 gorithm Block size Randomization groups Weighting of the groups Stratification Randomization list 2 Range minimization Groups A B X Block size n number A B X max number of one group maxNum n Vv Sort all randomized patients of the stratum by date of randomization y Collect only the randomized patients of the last incomplete block y num A number A in the last block num X number X in the last block y Possible groups A B X delete all groups with num maxNum v result random choice of the remaining groups A X Determination of randomization with Extended Stratified Block without list secuTrial al Only multiple totals of the number of randomization groups can be defined At least two All groups
138. ied and the current form is included All forms as of the selected date are frozen for input by setting the form status in the toxdocument to sysfreeze even if the form has already been manually frozen when one of the defined conditions is met As the patient status is not changed the patient as such is classified as active The rule Free following forms if can be used to cancel the frozen status again see rule Free following forms if Casenode forms for the departure of patients or inclusion and exclusion criteria premature cancelling of data capture Caution with the combination with Free following forms The rules do not cancel each other but are both executed Free single form if Can be applied to Condition Type Check Form status Casenode status Error message Effect Usage All item components except DB Dummy Layout Dummy and all calculable items without entry Score Date Interval Date section Depending on field type Action Saving revalidation No effect No effect No Selective cancelling of freezes in a defined form When the rule condition is fulfilled the form which has been specified in the rule will be opened everywhere that it has been frozen before Is it a visit form it will be opened in all created visits Selective withdraw the premature cancelling of data capture in a defined form Caution with the combination with Freeze single form The rules do not can
139. ient lt LAB ID gt Lab ID of the patient lt RANDOM gt Randomization s of the patient in a blinded randomization the randomization number of the patient will be shown in a unblinded randomization the randomization group of the patient For all message types it is possible to select the included information individually Content Email format HTML Title Message from Visite 1 lt RANDOM gt Ke Notes Text for automatic delivery Start of message Dear Mr Contains Patient Pat ID Add ID Lab ID URL to patient Form URL to form Centre Name Email Participant Name Role Address Email End of message Best regards Fig 74 Selecting the standard information for the content of a message The available selection options differ according to the message type this example shows the configuration of a follow up form message The following options can be selected Note regarding automatically generated e mail To prevent users from trying to answer automatically generated e mails the note This is an automatically generated e mail Please do not reply to this message can be placed at the be ginning of the e mail Note regarding multiple messages Note Only configurable for form messages If a message is defined as a form follow up action this may be triggered and sent multiple times if a form is edited more than once The defined notific ation text will be placed above the message if the mes
140. ified The value for calculation is read out from the conversion factor if this is set in the case of fields with groups of labels Otherwise the normal DB value is used Type Check Form status Casenode status Error message Effect Usage Comments Action Saving revalidation item or form button Completion status following calculation Attention further rules for completion checks should be placed after the calculation rule No effect No The field values are linked with the specified operators normally addition The total value is divided through the number of calculated values and multiplied with the given normalization factor 1 if not specified If the field values do not specify any greater accuracy the normed score is specified to two decimal places The score is calculated on request button click or on saving the form In the case of groups of labels the conversion factors are used for calculation purposes if these are set Otherwise the DB value is used Standard scores Scores are calculated on score fields with rules which usually consist of several conditions When defining multiple score rules on an item they will be calculated in the defined sequence and only with fulfilled preconditions The value calculated last will then be saved Delete patient pseudonyms if Can be applied to Condition Type Check Form status Casenode status Error message Effect Usage P
141. ig TPX document mnpdid TPX subdocument childdid B ptopdid emnpT PX mnpTPX Anno cer cw cece sce O Pm e _ To enable simplified SQL statements for reports the structure of the medical project database schemes has been extended New columns have been intro duced to allow the shortening of joins light blue lines The following tables have been extended TPX is the placeholder for the project scheme name TPXdocument pid NUMBER NULL Foreign key to Patient in the corresponding participant administration Value corresponds to the value in the related TPXcasenode Will only be set for main outer forms ctrid NUMBER NULL Foreign key to Centre in the corresponding participant administration Value corresponds to the value in the related TPXcasenode Will only be set for main outer forms TPXquery TPXcomment mnptopdid NUMBER NULL Foreign key to the outer TPXdocument of the query or comment If the query comment has been set for a main form this is the same value as in mnpdid Due to the double storage of the foreign keys to the patient and centre in the central TPXdocument table it is now much easier to retrieve summarised form in formation for a specific patient or centre for example the date of the last saved form There is no need to distinguish between casenode visit or adverse event forms in this case Thanks to the additional storage of the main form in queries and comments it is easier to list all queries or
142. ime of an observation represented in ISO 8601 character format Text description of time when a measurement or observation VSTPT yes Planned Time Point Name Char perm Timing Variables should be taken as defined in the protocol This may be LGpITESEnE ted as an elapsed time relative to a fixed reference point such as time of last dose See TPTNUM and TPTREF VSTPTNUM yes Planned Time Point Number Num perm Timing Variables Numeric version of planned time point used in sorting Planned Elapsed time in ISO 8601 character format relative to a planned fixed reference TPTREF such as Previous Dose or VSELTM yes Planned lapsed Tine non Char perm Timing Variables Pre vious Meal This variable is useful where there are repetitive Time Point Ref i A measures Not a clock time or a date time variable but an interva represented as ISO duration Description of the fixed reference point referred to by ELTM VSTPTREF yes Time Point Reference Char perm Timing Variables TPTNUM and TPT Examples PREVIOUS DOSE PREVIOUS MEAL VSSCAT yes Subcategory Char perm Grouping Qualifier Used to define a further categorization of CAT values
143. indings copied or derived from ORRES in a standard format or in standard units STRESC sho uld store all results or findings in character format if results are nu Result or Finding in Standard Se meric they should also be stored in numeric format in S TRESN mon RES yes Format phar ERD y RESU Guaimar For example if various tests have results NONE NEG and NEGATIVE in ORRES and these results effectively have the same meaning they could be represented in standard format in STRESC as NEGATIVE SS Used for continuous or numeric results or findings in standard QSSTRESN yes Numeric Result Finding m Num perm Result Qualifier format copied in numeric format from STRESC STRESN Standard Units eet should sto re all numeric test results or findings E Variable Qualifier of Standardized units used for STRESC and STRESN Example QSSTRESU yes Standard Units Char perm STRESC and STRESN mol L QSBLFL yes Baseline Flag Char exp Record Qualifier Indicator used to identify a baseline value Should be Y or null Used to indicate a derived record e g a record that represents the QSDRVFL yes Derived Flag Char perm Record Qualifier average of other records such as a computed baseline Shoul d be Y or null QSDTC yes Date Time of Collection Char exp Timing Variables Collection date and time of an observation represented in ISO 8601 character format Text description of time when a measurement or observation QSTPT yes Planned
144. ing revalidation No effect No effect No The status of the adverse event AE SAE to which the form belongs is set to Closed The further creation of examinations follow ups in this AE is therefore no longer possible Adverse event forms Open adverse event if Can be applied to Condition Type Check Form status Casenode status Error message Effect Usage Take value from Can be applied to Condition Type Check Form status Casenode status Error message Effect Usage All item components except DB Dummy Layout Dummy and all calculable items without entry Score Date Interval Date section in a adverse event form Depending on type Action Saving revalidation No effect No effect No The status of the adverse event AE SAE to which the form belongs is set to open The further creation of examinations follow ups in this AE is therefore again possible Adverse event forms reverse rule for Close adverse event All item components except DB Dummy Layout Dummy and all calculable items without entry Score Date Interval Date section Specification of the item as a parameter is omitted Action Initialisation of unsaved forms or new repetition groups No effect No effect Error message if adopted value Wert added value does not match the defined item format and can not be displayed e g value 10 in a 1 0 number field The valu
145. ing in Original oe Result of the measurement or finding as originally received or col SCORRES lyes Units Char exp Result Qualifier lected Examples 120 lt 1 POS Name of Measurement Test or Synonym Qualifier of Long name For TESTCD Examples Platelet Systolic Blood See Yes Examination Ghat red TESTCD Pressure Summary Min RR Duration Eye Examination Short character value for TEST used as a column name when Short Name of Measurement converting a dataset from a vertical format to a horizontal format SG TESTER yes Test or Examination Ghar eq hopie Th e short value can be up to 8 characters Examples PLAT SYS BP RRMIN EYEEXAM SCSCAT yes Subcategory Char perm Grouping Qualifier Used to define a further categorization of CAT values Used to indicate when a question about the occurrence of a pre SCSTAT yes Completion Status Char perm Record Qualifier specified intervention was not answered Should be null or have a v alue of NOT DONE SCORRESU yes Original Units Char perm ae a Unit for ORRES Examples IN LB kg L SCREASND yes Reason Not Done Char perm Record Qualifier Reason not done Used in conjunction with STAT when value is NOT DONE SCDTC yes _ Date Time of Collection Char perm Timing Variables Collection date and time of an observation represented in ISO 8601 character format Variable Qualifier of Standardized units used for STRESC and STRESN Example SCSTRESU yes Standard Units Char perm STRESC and STRESN
146. ionGroup must be created for repeated selection Diagnosis Comment H Query How often does the symptoms lt Please choose gt y y occur sometimes dail Fig 30 Example of the view of a pop up item The question Diagnosis is answered by selecting an option in the selection list The DataCapture view shows the selection list folded down Creation and editing are carried out as for the radiobutton The text for not selected options data bank value NULL Default lt Please choose gt can be configured per item as well Format check Not necessary Consistency check Can be created in ASStandardGroup lASAlternateStandardGroup lASHorizontalGroup IAS UnitGroup automatic and ASHorizontalUnitGroup automatic Non productive Cannot be changed or deleted in ASUnitGroup and lASHorizontalUnitGroup Productive Can be changed to horizontal or vertical radiobutton except in ASUnitGroup and ASHorizontalUnitGroup where it cannot be changed Conversions between horizontal and vertical radiobuttons and pop up items are possible as long as the external question component does not prescribe any restriction for the item types contained e g only horizontal radiobuttons are allowed in radiobutton matrix components The group of labels is checked as regards the clarity of the assigned sequence DB values and texts distinction between capital and lower case letters The check for unambiguousness
147. isfied you are at this time Comment Please answer each item even if you do not currently participate in an activity or have a relationship You can be satisfied or Query dissatisfied with not doing the activity or having the relationship A Mostly Mostly DIEE Terrible Delighted Pleased Satisfied Mixed Dissatisfied Unhappy rri i Material comforts home food C C C C C c C conveniences financial security 2 Health being physically fit and C C C C C C C vigorous Relationships with parents 3 siblings amp other relatives C C C C C C O communicating visiting helping 4 Having and rearing children 5 Close relationships with spouse or C significant other Fig 10 Example of the view of an IASHorizRBMatrix consisting of five items On creating and editing the group of labels of a radiobutton in a RB matrix the changes are always transferred to all groups of labels of all radiobuttons for the question For the lASHorizRBMatrix it is also possible to display a reset option This option can be added as the first or last option to the other answer options The button text can also be edited When saved changes made to one radio button in a matrix will be transferred to all other radio buttons within the matrix Layout settings IASHorizRBMatrix To influence the table design for a radio button matrix CSS classes have been introduced for the table elements To edit the CSS a layout assistant can be opened in a separate window
148. item can be used to query numerical values of any size Both the number of places in front of the point and those after the point must be defined in advance In this case Number x y means Number field with x places before and y places after the point Measure of blood pressure Comment systole mm Hg Query diastole mm Hg Fig 37 Number fields with the format Number 3 0 Year of first diagnosis yyyy Dose J number of pills per day Fig 38 Number field with the format Number 2 1 The unit in which the input is to be interpreted can be portrayed behind the number field For all number items it can be configured whether thousands should be displayed in text format with or without a thousands separator This applies to the print view for forms numbers displayed in the audit trail and in reports During exports all numbers will be exported without a thousands separator as was the case in the past Format check Only the input of numbers is permissible The number s pre and any post decimal places are input in separate fields with the result that the format of the decimal point is irrelevant The only Non numerical character which is permitted is a single minus symbol in the pre decimal field Ifthe input of negative numbers is to be anticipated it must be noted that the minus symbol is also counted as a number digit If necessary the pre decimal field must then be selected one digit larger Consistency check Can
149. ith a score via radiobuttons Format check During calculation division by 0 is checked and an error message is displayed instead Consistency check Can be created in ASStandardGroup lASAlternateStandardGroup lASHorizontalGroup IAS UnitGroup and lASHorizontalUnitGroup Non productive Cannot be changed as long as score rules are created for this item Productive Cannot be changed Time Interval Date Interval The time date interval field can be used to calculate time intervals On creation of such an item the calculation rule Calculate date time interval from is also automatically created Precisely two time fields between which the interval is to be calculated must then be created as a condition for this rule The following interval formats are available for selection Time interval H M calculated only Time interval H M S calculated only Time interval M S calculated only Date interval Y calculated only Date interval Y M calculated only Date interval Y M D calculated only Date time interval Y M D H M calculated only Calculation of the interval is carried out in the form via a score button as in the case of the numerical scores The calculated value is portrayed in text form The search for interval fields is carried out by inputting individual values per interval field Format check Not necessary Consistency check Can be created in lA
150. l visits absolute values in the relevant visit are always portrayed Evaluated status The user can choose between the two different types completion status and Review In the case of completion status you have the option of choosing between the values Completely filled and data entry complete in the drop down list In the case of Review you may choose between the values medical review A data review B review A B and manual freezing in the drop down list Visit As visit forms may be displayed multiple times in various visits and the medical data records are stored in the same table the visit from which the data record for the statistics is to be taken additionally has to be specified in the case of certain statistics types so that each patient is only counted once The data record saved first or last can be selected to do this On creation of the statistics for a specific visit the visit type which this involves visit 1 visit 2 etc must be specified in the drop down field This step is omitted in the case of statistics on all visits and casenode Item On creation of statistics on discrete items radiobuttons and popup items or numerical items the item from which the value is to be read out must also be specified in addition to the above described data To do this select the form in which the item is found from the front drop down list The item can now also be selected in the rear drop down list
151. lter option enables only queries with certain properties to be called up 31 08 2010 20 13 CEST Close j Dipl biol Susanne Schneider secu ria Study 1 31 08 2010 19 56 00 CEST Print Queries lt All gt z lt All gt HEE z lt All gt z lt All gt z lt All gt lt All gt z lt All gt x gt M 1213 xyx219 Centre B Dr Jonas 31 08 10 Personal Data Date of birth Y 1214 xyx219 Centre B Dr Jonas 31 08 10 Personal Data Picture 2 Dr Ulrike Jonas 31 08 2010 20 07 CEST The picture is still missing Dipl biol Susanne Schneider 31 08 2010 20 12 CEST Sorry answer to wrong query Picture has been added lately v M 1215 xyx219 Centre B Dr Jonas 31 08 10 Diagnosis How often does the symptoms occur Dr Ulrike Jonas 31 08 2010 20 08 CEST This value is unlikely with the diagnosis above Dipl biol Susanne Schneider 31 08 2010 20 12 CEST No this was exactly measured gt M 1216 jqj789 Centre B Dr Jonas 31 08 10 Personal Data Weight Fig 62 Example of the view of a query report The portrayal is roughly comparable with that of an SQL report The queries can be sorted using the grey title bars and filtered via the drop down lists Clicking onto the triangles at the start of the line enables the questions and answers to be shown and hidden The patient can be called up via the pseudonym clicking onto the form and question text immediately calls up the corresponding form This enables a rapid overvie
152. lthy control persons do not have to fill in any further forms Usage Visit forms to generate dependencies between forms Form input only possible if Can be applied to All item components except DB Dummy Layout Dummy and all calculable items without entry Score Date Interval Date section Condition Depending on field type specification of the item as a parameter is omitted Type Action Check Form prerequisites check Form status No effect Casenode status No effect Error message No Effect This rule has no effect whatsoever in the form in which it is created It is intended to be selected as a prerequisite in other forms E g Healthy Usage Limit reached if Can be applied to Condition Type Check Form status Casenode status Error message Effect Usage Comment control persons do not have to fill in any further forms This rule is the pendant to Form input not possible if which of the two is more sensible has to be checked in the individual case Visit forms to generate dependencies between forms All item components except DB Dummy Layout Dummy and all calculable items without entry Score Date Interval Date section Depending on field type Value range Saving revalidation Completion status according input No effect Yes default Limit reached On meeting one of the defined conditions the error message is displayed to the user and the user cannot
153. ly defined units which are converted into a reference unit for saving in the database The first question is a number field for inputting the measured value the second consists of a pop up which contains the units Welcome gt Project gt form family gt Form gt Question gt Item Project Study 1 25 08 2010 11 52 52 CEST Form family Laboratory forms Form Laboratory measurements Question ASUnitGroup Type Popup Beschr Gruppe Edit group of labels Displayed Label DB Conversion factor order value ID 1 mg 2 1000 0 5157 2 g 1 1 0 5156 3 kg 3 0 0010 5158 Database column ugm D D CDISC ODM export annotations Containing rules 2 Displayed order Name Type Following action Delete from database gt fio Please select a unit Input required if Delete gt fr Input not required if Delete Cancel Save and back Save top Fig 19 Editing page for the unit pop up of an ASUnitGroup in the FormBuilder Conversion is carried out via the conversion factor of the pop up s group of labels Prior to saving in the database each number field is calculated using the conversion factor In this case the reference unit must be given the conversion factor 1 and is taken over unchanged into the database Other wise the input measured value is divided by the conversion factor and the result is saved in the database For portrayal purposes the database value is then multiplied by the conversion fac
154. ment Four defined statistics which are listed in the following and for which additional parameters have to be selected are available for displaying information on the status of recruitment Patients over time Patients according to centres Patients according to centres over time Patients over visits Data fields Six statistics which are listed in the following for which the item from normal visit or casenode forms has to be specified besides additional parameters and from which the data are read out are available for displaying information from specific data fields Discrete items one visit Discrete items all visits Discrete items casenode Numeric items one visit Numeric items all visits gt Numeric items HA A Sa Sa a casenode Discrete items refers to the group of items which are stored in the database with a firmly defined value e g radiobuttons and pop ups n Numeric items refers to number fields One visit means the portrayal of the number of patients with a specific item content from a specific visit All visits means the portrayal of the number of patients with a specific item content over all of a visit plan s visits Casenode means the portrayal of the number of patients with a specific item content from a casen ode form a There are no statistics regarding adverse event forms 6 3 Configuration options Categor
155. message will be sent for each individual query In addition you can assign HTML tags to the definition of beginning and end texts by selecting the configuration HTML Format This also means vice versa that simple line breaks within the tem plates will be ignored With HTML formatted messages the automatically included information from form questions will also be formatted similar to the way in which messages copies are displayed in DataCapture The preset question texts will be displayed in bold face and the data entered by the user will be displayed with normal formatting Project messages Bundled messages Bundled messages in secuTrial are messages which are generated when processing queries on automatic reset of a SDV status or at empty visits These are not dispatched directly but are initially collected and dispatched at the defined point in time and interval The point in time and interval are set in the AdminTool whereas the message content is set in the FormBuilder In this case identical message types are summarised If e g 10 queries are submitted when monitoring a single patient these are summarised to form one message see note for bundled message dispatch above Multiple messages can be defined in a project for the different triggers in the query work flow For example this makes it possible to define a message for a new query in different languages This can then be sent to different roles according to the langua
156. milar to the pop up items the contents are saved as references In the case of extendable lookup tables the user in the DataCapture can subsequently add values Unlike pop up items the values in the lookup table itself are also saved in the project s medical data base scheme and not in the multi project scheme of all project setups Please describe a normal day of life Comment mo a Favorite activity Reading z Query Other Usual activity watching TV D gt lt Please choose gt gt Selection Note Fig 41 Example of the view of an extendable lookup table with the list of specified entries top and the view with the option of creating new entries bottom The drop down lists show the correspondingly filtered selections In the DataCapture the specified entries and the values input by the participants are offered in two different lists Switching is carried out via the SELECTION OTHER button In the FormBuilder the entries are marked on the editing page of the lookup table with FormBuilder or Participant Project Study 1 30 08 2010 17 30 46 CEST Lookup tables Study 1 7 Description Database table Extendable Parent table Created Date Entries Usage Breed mnpprobbreed O Pet lt Imnpprobpet gt M 25 08 2010 11 07 CEST 6 3 Colour mnpprobcolour O Breed lt Imnpprobbreed gt m 25 08 2010 11 12 CEST 14 3 Favorite activities Imnpprobactivity M 30 08 2010 17 21
157. mization buttons and catalog fields can be created as additional items The two unit items cannot be deleted even when they are non productive In the sequence the unit pop up is always positioned directly behind the unit number field IASCatalogGroup An ASCatalogGroup enables the usage of large hierarchical structured catalogs to be used as ref erence books The catalog must first be created within the customer see the FormBuilder manual On creation of an ASCatalogGroup the catalog from which the values are to be subsequently read out must be specified in addition to the standard data such as question text and sequence If an ASCatalogGroup with items has been created the user is able to open a window in which he can search for and select the desired value in the DataCapture by clicking onto the CATALOG but ton field marked in colour on the outer left Following selection the available values are transferred from the catalog to the form and the catalog window is closed The values are copied from the cata log as independent text and not only referenced from the catalog If the assigned catalog is changed and catalog items have already been created these are deleted following one warning notice Possible fixed catalogs At present automatically created in secuTrial versions prior to 3 3 only 9 catalogs are firmly imple mented in secuTrial these each form an excerpt of the cardiovascular diseases from the overall EPCC
158. n Char perm Record Qualifier Denotes the indication for the intervention e g why the therapy was taken or administered CMDOSU yes Dose Units Char perm Variable Qualifier of Units for DOSE DOSTOT or DOSTXT Examples ng mg DOSE mg kg CMREASND yes Reason Not Done Char perm Record Qualifier Reason not done Used in conjunction with STAT when value is NOT DONE Collected duration of an event intervention or finding represented CMDUR yes Duration Char perm Timing Variables in ISO 8601 character format Used only if collected on the C RF and not derived CMSTDTC yes Start Date Time of Observa Char perm Timing Variables Start date time of an observation represented in ISO 8601 charac tion ter format CMENDTC yes na Date Time of Observa Char perm Timing Variables A of the observation represented in ISO 8601 character Variable Qualifier of Text description of the intended schedule or regimen for the Inter SOMPE ROM yas jntenided Dose Regimen ANa Pm DOSE vention Examples TWO WEEKS ON TWO WEEKS OFF CMSCAT yes Subcategory Char perm Grouping Qualifier Used to define a further categorization of CAT values CMDOSTOT yes Total Daily Dose Num perm Record Qualifier Total daily dose of TRT using the units in DOSU Used when dosing is collected as Total Daily Dose Dosing Frequency per Inter Variable Qualifier of Usually expressed as the number of doses given per a specific in EMDOSERQUVES gt al Shar pem DOSE terval Examples
159. n asides iiiaae a a aaa ai aE aaa aaia a dep aAA a a 33 Checked Date ica id ENa aA da adas 33 NUM DE iiaia A id 33 Vox Mel iii A ad 34 VOX ii a AA A din i 35 LOOKUP Table iii ii 35 Lookup Table not extendable jacini eaaa E 37 Score only calculated icono EEE a a 37 Time Interval Date Interval ooooooonnnnciccccocccccccccnnncnnccnonnnnnnnnnnononnnncnnnnnnnnnncnnnnnnnnnr nana ana nncnnnnns 38 Date score fields for calculation in NUMbEeTS oooonnncccccocccococonocononcccnnncnnnnnnnnnnnnnnncnnnnonnnnnnnnnnnnns 38 Configurable Randomization BUttON sssri sisien nni ienn ai 39 Simple Randomization Button ccccccccccceeeeeeeeeeeeeceeeececaneeceeeeeeeeeeeeeeseeeeeeeeaaneeeeeeeeeeea 47 DB DUMMY cirein ieia da deed dine eee 48 Layout DUMMY a A E 48 nare gt A EE E E E I E AE EE diaienldeaandeiesd 49 catalogo ideene aa E ad 50 20 Layout NOl it E T eee ane 51 RUE PES ii se eth rate eek aaah E 54 3 1 Rule types and conditons oceania litis 54 Rules without A 54 RULES WITH conditions ane a aaa 55 Rules with preconditions and execution CONCItIONS ccccccceeeeeeeeeeeeeeeeeeeeeeeaneeeeeeeeeeas 55 3 2 Rule types and eleccion 55 Generic Assembling of Input Interface ooooncinnoncccnnnnnoccccccconananccnnnonnan cnc nn nono nc cnn nn nnnn nn cnn 56 Calculation of the form completion statuS ccccccceceeeeeeeeeeeeeeeeeeccacaeeeeeeeeeeeeeereeeeeesaas 56 Wale rane Che CK ici tasa ia ace cli iia
160. n site RATOS YES tion Ghar y per Record Qualifier Example RIGHT ARM for an injection EXLOT yes Lot Number Char perm Record Qualifier Lot number for the intervention described in TRT EXROUTE yes Route of Administration Char perm Variable Qualifier of TRT Route of administration for the intervention Examples ORAL IN TRAVENOUS Variable Qualifier of Text description of the intended schedule or regimen for the In EADOSROMives Inonded ROSE REJIMEN Chal tipem BOSE tervention Examples TWO WEEKS ON TWO WEEKS OFF E so Total daily dose of TRT using the units in DOSU Used when EXDOSTOT yes Total Daily Dose Num perm Record Qualifier dosing is collected as Total Daily Dose Dosing Frequency per Inter Variable Qualifier of Usually expressed as the number of doses given per a specific in EXDOSPRA Yes val Char perm DOSE terval Examples QD BID TID QID Variable Prefix Variable label Type Core Role Description EXDOSFRM yes Dose Form Char exp ee Qualifier or Dose form for the treatment Examples TABLET CAPSULE q Variable Qualifier of Units for DOSE DOSTOT or DOSTXT Examples ng mg EXDOSU yes Dose Units Char exp DOSE mg kg a wes Dosing information collected in text form Examples lt 1 per day EXDOSTXT yes Dose Description Char perm Record Qualifier 200 400 Not populated when DOSE is populated The topic for the interv
161. natively copy the URL in the browser s address line and the usual login page for DataCapture will be initially displayed The participant signs in with their usual user name and password After successful authentication the participant will be directly taken to the form overview of the patient with patient URL or form view with form URL If the participant does not have the rights to edit that patient or form after successfully logging in an error page will be displayed and the participant will remain on the Welcome page The URLs are also contained in internal messages for example in sent messages Clicking on the URL will likewise open the DataCapture login page even though the participant has already logged In Centre Name Note 7 2 E mail Participant If Name and Role are selected they will be summarised in one row If only one option is se lected then Participant for Name or Role will be put first Name Role Address E mail When defining messages for bundled message dispatch please bear in mind that the more specific the content the more messages will be sent This is because bundling is based on a comparison of the message content For example if only the centre and the patient are contained as general information in a query mes sage only one message will be sent for each of the patients within the dispatch interval If the query text is also included a separate
162. ndomization button still exists in the project Form it is not possible to simultaneously configure a form as a DDE form and a randomization form Ina randomization form stratification factors can only be specified if no relative or absolute visit has been entered The factors for the current patient are always taken from the current entry in the randomization form Button The stratification factors for a randomization button in a form which has not been additionally defined as a randomization form can only be taken from other forms This guarantees that the randomization is implemented on the basis of saved stratification factors Randomization lists If a randomization button is deleted any randomization lists which have already been uploaded will also be deleted Randomizations which have already been executed for test patients will also be deleted This is only possible in the setup area If only individual stratification factors or levels are deleted from a randomization definition the corresponding references to these stratification factors in the randomization list will also be de leted In this case previously executed randomizations in test patients will not be deleted Simple Randomization Button If you only require a simple randomization without the additional options of the configurable random ization button this button enables you to distribute patients randomly into one of two groups To use the simple
163. ng in Original Les Result of the measurement or finding as originally received or col DAORRES yes Units Char exp Result Qualifier lected Examples 120 lt 1 POS DAORRESU yes Original Units Char perm a en Unit for ORRES Examples IN LB kg L Contains the result value for all findings copied or derived from ORRES in a standard format or in standard units STRESC sho uld store all results or findings in character format if results are nu Result or Finding in Standard m meric they should also be stored in numeric format in S TRESN PAGERE SG YES Format enar exp Resu Quelle For example if various tests have results NONE NEG and NEGATIVE in ORRES and these results effectively have the same meaning they could be represented in standard format in STRESC as NEGATIVE Numeric Result Finding in Used for continuous or numeric results or findings in standard DASTRESN yes q 9 Num perm Result Qualifier format copied in numeric format from STRESC STRESN Standard Units e should sto re all numeric test results or findings Variable Qualifier of Standardized units used for STRESC and STRESN Example DASTRESU yes Standard Units Char perm STRESC and STRESN mol L DADTC yes Date Time of Collection Char exp Timing Variables Collection date and time of an observation represented in ISO 8601 character format DM Demographic Special Purpose
164. ntion further rules for completion checks should be placed after the calculation rule No effect No The score is calculated from the selected fields or and a defined decimal number This rule is exclusively intended for score fields The score is calculated on request button click or on saving the form In the case of Usage Comments groups of labels the multiplication factors are used for calculation purposes if these are set Otherwise the DB value is used Please refer to the Scores section for the precise function For calculating sum values from other questions Scores are calculated on score fields with rules which usually consist of several conditions When defining multiple score rules on an item they will be calculated in the defined sequence and only with fulfilled preconditions The value calculated last will then be saved Calculate score function from Can be applied to Condition Type Check Form status Casenode status Error message Effect Usage Comment Open serious adverse Can be applied to Condition Type Check Form status Casenode status Error message Effect Usage Score Fields from which the value is to be calculated Action Saving revalidation button Completion status following calculation Attention further rules for completion checks should be placed after the calculation rule No effect No The score is calculated via the speci
165. o stored as a number in the database they are genuine references and are also portrayed differently in the internal secuTrial data model This item type is portrayed horizontally Allergies C dog cat C house dust Fig 25 Example of the view of a horizontal radiobutton There are two ways to reset a radiobutton A radiobutton component without a reset option can be completely reset to NULL by double clicking on a selected answer option This will then deselect all options in the radiobutton A radiobutton component with a reset option can also be reset by selecting the radiobutton re set option Double clicking on a selected answer option will automatically select the reset op tion The position of the reset option can be placed at the beginning or the end of the defined options Sex not applicable C female C male Fig 26 Example of the view of a reset radiobutton with the answer options female male and the reset option at the beginning The position of the reset option can also be set for the horizontal radio buttons as the first or last option In the case of the radiobutton a group of labels must be compiled in the FormBuilder The item type and the relevant database column must be specified first plus a relevant question text if desired This must be saved and the group of labels can then be edited Type Horizontal Radiobutton M with reset option Edit group of labels Displayed DB Value for sc
166. of the text are only made as a warning CheckBox As a non answer the check box is not clicked is also a valid statement in the case of check boxes the rule Input not required is also created as specified so that the completion status takes this into consideration If desired of course this rule can be removed again or edited Welcome gt Project gt form family gt Form gt Question gt Item Project Study 1 25 08 2010 18 30 32 CEST Form family Base Examination Form Diagnosis Question sample Type CheckBox zl Displayed order 10 shown no Item Unit format HTML yes Database column blood D gt CDISC ODM export annotations Containing rules 1 Displayed order Name Type Following action Delete from database fio Input not required Delete New rule _ Cancel Save and back _Save top Fig 31 Editing page for a check box in the FormBuilder Blood sample taken I yes Comment Query Fig 32 Example of the view of a check box the text behind the check box originates from the field Unit format Special feature of an ASCheckboxMatrix The same question text must be specified as the question text for all check boxes within a row in this case In the second step each box is then assigned with the corresponding label text All boxes in a matrix which are contained in the same column must have the identical same ID label text The value of the sequence which is spe
167. of the number field not for the redisplay of the user input value in the number field No rules can be created on a DB Dummy component Rules for checking the reference values can be created on the number field of the UnitGroup It is recommended to use a DB Dummy component in all UnitGroups to store the user entered input directly Format check Not necessary as no user inputs or selection take place Consistency check Can be created in IASUnitGroup and IASHorizontalUnitGroup Productive Cannot be changed Layout Dummy This component contains no data input and is used to structure the layout in the form as a place holder If you always have three items and two items in only one question e g in several lASHori zontalGroups lying beneath each other this component can be created there as an additional 3rd item The alignments are therefore maintained in the form layout This component can be labelled and a desired width in pixels can be specified On use as a pure place holder however this is not necessary Note Nutrition habits 1 Comment What do you normaly eat at breakfast Query Main drink Do you at at home Enter major part of food C tea coffee C juice T yes AAA Nutrition habits 2 Comment What do you normaly eat at lunch Query Main drink At work Enter major part of food Ctea coffee C juice Di Fig 46 View of two IASHorizontalGroups the lower one with integrated layout dummy Lab
168. ondition Type Check Form status Casenode status Error message Effect Usage Input impossible if Can be applied to Condition Type Check All item components except DB Dummy and Layout Dummy Depending on field type Action Saving revalidation No effect No effect Yes default Please confirm this entry On meeting one of the defined conditions the user is presented with an error message After confirming again saving the form is saved For improbable but permissible inputs e g age of the patient with Alzheimer s disease lt 40 status All item components except DB Dummy and Layout Dummy None Form status Saving revalidation Completion status complete No effect No A user input in this field is irrelevant to the completion status of the form All forms Additional information status if All item components except DB Dummy and Layout Dummy Depending on field type Form status Saving revalidation Completion status when the condition is met the field is regarded as complete otherwise following input No effect No A user input in this field is irrelevant to the completion status of the form if one of the defined conditions is met All forms Additional information All item components except DB Dummy Layout Dummy and all calculable items without entry Score Date Interval Date section Depending on field type Value range Saving form
169. ooncccccccconoocccccncnnnncncnnnnnnnnnn non nnnnnnnnnn nn nn nn errar nan nn nn nn nn nnnnrnnn rn nrr rra 14 AS O seisein nso nirennaan iiaeaae iakin anae aa ieie iaaa ia anaiai iaat 16 IAS Vert B Matrix senenin aiian i eaa Eaa aaa aiena inienn 17 IASCheckboxMatrix cccccccccceeeeeeeeeeeeteceeeeaaaaeeeceeeeeeeeeeeesesaaaaccsaaaaeaeeceeeeeeeeeeeeeeeeseaaaaees 18 IASMultipleSelection cccccccccccceeeeeeeeeeeeeeeeneeceeeaeeeeeeeeeeeeeeeeeeeaaaaaaeaeaaaeeeeeeeeeeeeeeeeeeeeeees 19 IASCombinedSele ction ccccccccccceeeeeeeeeeeeeeccenneneaeeeeeeeeeeeeeeeeeeesececeeceaneaeeeeeeeeeeeeeeeeeeeeees 20 IASHorizCombinedSelection cccccccccccceeeeeeeeeeeeeeeeececeeeeeeeeeeeeeeeeeeeeteseececceeeeeeeeeesaaeeeeeees 21 VAS UNG FOU Pc iteraci n 21 IASHorizontalUnitGrouD 2 eccecceceeeeeeeeeeeeeeeeeeeeeceaaaeeeeeeeeeeeeeeeeeeedeseceeceneceeeeeeeeeesaaaeeees 23 IAS Catalog Group icccedccvinyesdccinesdetey onedeaccoyshities adi 0a bended ue cea ead galas sas Wiles A anentddadebaaanaane 23 WAS er A dead ds anactinaabsend dacav boas ddgaatiodawsaveh he besadeavhnsaannunhgeibanduaddesshaptaccpdecaacaumidaniee 25 2 4 MOM TYPOS acaricia fede el ahead iia aa 26 Horizontal radiobDutton s in nsa inni nan a annaia aaea anaa aE Eai 26 Vertical Radiobutton ceiien ae ar a ia aeaiia ea aiaa akaa Eaa aaa Da 29 O 29 CHECKBOX ve econo rra Ae E 29 NMG A E EAE snes T E E O 30 DAG A E T E TAE A T E 32 Checked TG scie
170. or defined reference point referred to by ENRTPT Examples 2 003 12 25 or VISIT 2 SUROUTE yes Route of Administration Char perm Variable Qualifier of TRT Route er SOI ao me ORAR TRAVENOUS SUSTDTC yes Start Date Time of Observation Char perm Timing Variables es Obamobsensalion represented noU Badi charag SUENDTC yes End Date Time of Observation Char perm Timing Variables lab Oi ine oral e presented TOU 8001 Chatac Collected duration of an event intervention or finding represented SUDUR yes Duration Char perm Timing Variables in ISO 8601 character format Used only if collected on the C RF and not derived Identifies the start of the observation as being before during or after the sponsor defined reference period The sponsor define d SUSTRF yes etait Ralatvenolssloionce Char perm Timing Variables reference period is a continuous period of time defined by a dis Period f p f crete starting point and a discrete ending point represented by RF STDTC and RFENDTC in Demographics SUENRF yes End Relative to Reference Peri Char perm Timing Variables Identifies the end of the observation as being before during or od after the sponsor defined reference period The sponsor defined r eference period is a continuous period of time defined by a dis crete starting point and a discrete ending point represented by Variable Prefix Variable label Type Core Role De
171. ore Label order value calculation ID 0 not applicable Default 2 NULL 1 female 1 598 2 male 2 602 Displayed order 50 shown no Item Sex Database column gender a Fig 27 Excerpt from the editing page of a horizontal radiobutton item with reset option in the FormBuilder The answer option labels can be created and or edited via Edit group of labels An alternative text other than Not applicable can be entered directly for the item in the corresponding field this NULL option is always displayed first in the option list If another text has been entered the default text can be restored using the Default button In con trast to the default labelling an entered text will only ever be displayed in the entered language re gardless of the currently selected user interface language Important Welcome gt Project gt form family gt Form gt Question gt Item Project Study 1 25 08 2010 15 19 59 CEST Form family Base Examination Form Personal Data Question Patient description 1 Item Sex Edit group of labels Patient description 1 Sex lt gender gt Inscriptions already used should not be changed contentwise text DB value Conversion factor ID Delete from Compilation No 1 female 1 598 Remove ES 3 al 2 602 Remove New label Existing Labels Multiple choice with CTLR Unused labels in this project cat 2 599 standard 1 1 0 5155 daily 2 5136
172. ory Char perm Grouping Qualifier Used to define a further categorization of CAT values MB Microbiology Specimen Findings General Observation Class Variable Prefix Variable label Type Core Role Description MBNAM yes Laboratory Vendor Name Char perm Record Qualifier dc mente gy oa povided Variable Prefix Variable label Type Core Role Description MBORRESU yes Original Units Ghat pen peewee co Unit for ORRES Examples IN LB kg L Variable Qualifier of Used to categorize the result of a finding Example MALIGNANT MBRESSAD yes Resull Calegory Chat B ORRES or BENIGN for tumor findings Pa Defines the type of specimen used for a measurement Examples MBSPEC yes Specimen Material Type Char perm Record Qualifier SERUM PLASMA URINE Variable Qualifier of Standardized units used for STRESC and STRESN Example MBSTRESU yes Standard Units Char perm STRESC and STRESN mol L MBSPCCND yes Specimen Condition Char perm Record Qualifier Defines the condition of the specimen Example CLOUDY Numeric Result Finding in Used for continuous or numeric results or findings in standard MBSTRESN yes 9 Num perm Result Qualifier format copied in numeric format from STRESC STRESN Standard Units f A should sto re all numeric test results or findings Method of Test or Examina A Method of the test or examination Examples EIA Enzyme Im MBMETHOD VES lign Gnam E
173. ould refer to Collection of Race m and Ethnicity Data in Clinical Trials FDA September 2005 for RACE no Race Char exp Qualifier Variables guidance regarding the collection of race http www fda gov cder guidance 5656fnI htm The ethnicity of the subject Sponsors should refer to Collection of ee a Race and Ethnicity Data in Clinical Trials FDA September 2005 ETEME aS Emily Shar pets ral variables for guidance regarding the collection of ethnicity http www f da gov cder guidance 5656fnl htm ARMCD i Planned Arm Code Char req Qualifier Variables ARMCD is limited to 20 characters and does not have special char acter restrictions ARM no Description of Planned Arm Char req Qualifier Variables Name of the Arm to which the subject was assigned DS Disposition Events General Observation Class Variable Prefix Variable label Type Core Role Description DSDTC yes Date Time of Collection Char perm Timing Variables Collection date and time of an observation represented in ISO 8601 character format Study Day of Start of Observa Actual study day of start of observation expressed in integer days DSSTOX yes tion Pu J Pena Miming Wallabies relative to the sponsor defined RFSTDTC in Demographics DSSTDTC yes Start Date Time of Observa Char exp Timing Variables Start date time of an observation represented in ISO 8601 charac tion ter format DST
174. ps However the above described procedure almost always guar antees equal distribution even in the case of a low basic population of test persons Each patient can only be assigned to a group once as the result of random subdivision is saved im mediately As long as the relevant form has not yet been saved the note Not saved is output be Note hind the portrayal of the randomisation group The name of the randomisation group is additionally stored in the form in a text field with a length of 5 The allocated group is displayed in brackets in the DataCapture behind the patient s pseudonym Format check Not necessary as no user inputs or selection take place Consistency check Can be created in ASStandardGroup lASAlternateStandardGroup and lASHorizontalGroup Productive Cannot be changed DB Dummy This component can only be created in an UnitGroup question component and will be created auto matically as a third item during creation of a new UnitGroup This component contains no input field or user interface at all only a database column In this column the user entry of the number input field of the UnitGroup is stored If a UnitGroup contains a DB Dummy component with a stored user input value this value is directly displayed in the number input field without any recalculation The calculation into the reference value of the UnitGroup is only done for the storage of the reference value in the database column
175. ptions have been specified on the items layer Horizontal Radiobutton female male E Date DD MM YYYY J J dd mmyyyy oe lf YES please specify below Demographic Data Sex Date of examination Allergies Horizontal Radiobutton with Reset not applicable yes no Dog not applicable yes C no Cat not applicable yes C no Others Textfield 40 Fig 49 Structure of a form with the aid of a combination of various item types HTML formatting Only pure text can be input in normal input fields in the FormBuilder In this case and source mater ial formats cannot be taken over In contrast German umlauts are automatically accepted In certain fields which require frequent formatting above all help texts text can be formatted with HTML tags The fields are marked with HTML behind the field designation However knowledge of these tags is required for this The most important of these will be presented in the following Special characters A amp Auml amp auml O amp Ouml 6 amp ouml 8Uumi amp uuml B amp szlig lt amp lt gt amp gt amp amp amp ld amp quot Font markups In the case of the following tags it must be noted that they must usually have one code at the beginning lt x gt and one at the end lt x gt of the marked section hence the notation lt b gt Bold lt b gt lt i gt talics lt i gt Paragraphs Break A return is activate
176. r req Grouping Qualifier Used to define a category of topic variable values IESCAT yes Subcategory Char perm Grouping Qualifier Used to define a further categorization of CAT values Short character value for TEST used as a column name when Short Name of Measurement converting a dataset from a vertical format to a horizontal format IETES TED 1988 Test or Examination Shar rey Topig Th e short value can be up to 8 characters Examples PLAT SYSBP RRMIN EYEEXAM IEDTC yes Date Time of Collection Char req Timing Variables Collection date and time of an observation represented in ISO 8601 character format Variable Prefix Variable label Type Core Role Description Result or Finding in Original Le Result of the measurement or finding as originally received or col IEORRES yes Units Char req Result Qualifier lected Examples 120 lt 1 POS Contains the result value for all findings copied or derived from ORRES in a standard format or in standard units STRESC sho uld store all results or findings in character format if results are Result or Finding in Standard as numeric they should also be stored in numeric format in S IESTRESC yes Format enar reg Result Qualiticr TRESN For example if various tests have results NONE NEG and NEGATIVE in ORRES and these results effectively have the same meaning they could be
177. rated which is then simply processed in sequence during the actual randomization For the distribution of the groups in the list various entries must be made Depending on the configuration the distribution is only guaranteed within a block Block size determination fixed or variable Block size Entry required for fixed determination Multiplier Entry required for a variable determination Here the block sizes are selected randomly with the size between block size and multiplier block size Restriction restricted or unrestricted With a restricted list the entered ratio cor relates exactly With unrestricted lists small deviations are possible Group allocation by Accrual or Ratio see below Randomization groups At least 2 Weighting of the groups Accrual specification of the number of patients per group Ratio spe cification of the ratio of the groups to each other specification of the number of patients when generating the list in the AdminTool Stratification not possible Randomization list required created in the AdminTool 6 Static stratified block randomization This algorithm is based on a two step procedure first a randomization list is generated which is then simply processed in sequence during the actual randomization For the distribution of the groups in the list various entries must be made The distribution is only guaranteed within the list The lists for the different strat
178. re Y and N Records toxicity grade using a standard toxicity scale such as the Ne i NCI CTCAE Sponsor should specify which scale and version is PEVORGE yes MOMCIN Tade Char i PENN REGO Anal used in the Sponsor Comments column of the Define xml docu ment AESTDTC yes nA Date Time of Observa Char exp Timing Variables de a of an observation represented in ISO 8601 character AEENDTC yes End Date Time of Observa Char exp Timing Variables End date time of the observation represented in ISO 8601 character tion format Collected duration of an event intervention or finding represented AEDUR yes Duration Char perm Timing Variables in ISO 8601 character format Used only if collected on the C RF and not derived Identifies the end of the observation as being before during or after End Relative to Reference the sponsor defined reference period The sponsor defined r efer AEENRF yes Beriod Char perm Timing Variables ence period is a continuous period of time defined by a discrete starting point and a discrete ending point represented by RFS TDTC and RFENDTC in Demographics AEENRTPT yes End Relative to Reference Char perm Timing Variables Identifies the end of the observation as being before or after the Variable Prefix Variable label Type Core Role Description Time Point sponsor defined reference time point defined by variable ENTP T
179. reference point such as time of last dose See TPTNUM and TPTREF MBTEST ee Name of Measurement Test char le Synonym Qualifier of Long name For TESTCD Examples Platelet Systolic Blood y or Examination q TESTCD Pressure Summary Min RR Duration Eye Examination snd A Collection date and time of an observation represented in ISO MBDTC yes Date Time of Collection Char exp Timing Variables 8601 character format Result or Finding in Original ae Result of the measurement or finding as originally received or col MBORRES yes Units Char exp Result Qualifier lected Examples 120 lt 1 POS Used to indicate a derived record e g a record that represents MBDRVFL yes Derived Flag Char perm Record Qualifier the average of other records such as a computed baseline Shoul d be Y or null Synonym Qualifier of Logical Observation Identifiers Names and Codes LOINC code MBECING ves LOIN Gods Soar pen TESTCD for the topic variable such as a lab test MH Medical History Events General Observation Class Variable Prefix Variable label Type Core Role Description Body system or system organ class from a standard hierarchy MHBODSYS yes Body System or Organ Class Char perm Record Qualifier e g MedDRA associated with an event Example GASTROINTESTINAL DISO RDERS Topic variable for an event observation which is the verbatim or MHTERM yes Reported Term Char req Topic pre specified name of the event Synonym Qualifier of ia ee If the valu
180. respectively applicable section of the complete list is determ ined and then assigned Randomization groups At least 2 Stratification Possible If stratification factors are entered only the corresponding sec tion of the imported randomization list will be used for the randomiza tion Randomization lists Required imported in the AdminTool Stratification factors The use of stratification factors differs according to the algorithm Stratifications factors can only be defined from visit forms or casenode forms Evaluation of the current patient only With external randomization and the static stratified block randomization the stratification is only evaluated for the current patient With these algorithms for randomization buttons in a simple form a relative visit must be entered as the source for the stratification factors just like with rule condi tions This is only necessary if the stratification factor is determined from a visit form With a randomization button in a randomization form the stratification factors are always evaluated from the current form regardless whether the form is contained within a visit and which visit Evaluation of all randomized patients For the algorithms extended stratified block without lists secuTrial range minimization and vari ance minimization the stratification factors for all other patients are required in addition to the strati fication factors for the current patient It is no
181. riable is useful where there are repetitive Time Point Ref measures Not a clock time or a date time variable but an interva represented as ISO duration EGTPTNUM yes Planned Time Point Number Num perm Timing Variables Numeric version of planned time point used in sorting Text description of time when a measurement or observation EGTPT yes Planned Time Point Name Char perm Timing Variables should be taken as defined in the protocol This may be represen ted as an elapsed time relative to a fixed reference point such as time of last dose See TPTNUM and TPTREF EGDTC yes Date Time of Collection Char exp Timing Variables Collection date and time of an observation represented in ISO 8601 character format Role of the person who provided the evaluation Used only for res EGEVAL yes Evaluator Char perm Record Qualifier ults that are subjective e g assigned by a person or a group Ex amples ADJUDICATION COMMITTEE VENDOR Variable Prefix Variable label Type Core Role Description Used to indicate a derived record e g a record that represents EGDRVFL yes Derived Flag Char perm Record Qualifier the average of other records such as a computed baseline Shoul d be Y or null EGBLFL yes Baseline Flag Char exp Record Qualifier Indicator used to identify a baseline value Should be Y or null EGMETH ate we Method of the test or examination Examples EIA Enzyme Im OD ye
182. rms are then listed in three rows patient visits AE SAE in the sequence of their creation The image family forms are not displayed automatically but only if they are created explicitly see above However selection of the possible forms is determined by the assignment of rights Subform The subforms which can be used in ASRepetitionGroups are created in this help family An optional qualification test can also be created in this family Any number of subform families with any number of forms can be created Subform forms are not displayed directly the assignment of rights also always occurs via the external main forms An entire range of diverse form components is available in secuTrial for both the question layer and the item layer The questions are mainly responsible for the layout of the form whilst the item types determine the type of data which are captured However there is also a range of types which allows only specific item types or makes special functions available 2 1 Value check in the DataCapture A set of rules also called plausibility check edit check FormLogic is the sum of all checks to which the DataCapture subjects the incoming data It can be subdivided into Format check Limit values Plausibility in the stricter sense Actions Format check Format checks are carried out prior to saving when values are input in the DataCapture These checks are firmly implemented for each item and cannot
183. rom database c fi Completion status Ok Status Print Delete C 2 Image overview Ok Image forms Print Delete C fs Queries Ok Queries details Print Delete mo IIE Incorret definition Single field Print Delete C B Height Ok Single field Print Delete c E Icon overview Ok Icon display Print Delete C F SQLReport Check status SQL Print Delete C B Weight Ok Single field Print Delete c 8 Multiple values Ok Single field per visit Print Delete Copy report New report No fi Name Completionstatus Type CSQL Single field C Single field per visit Status C Queries details C Icon display Image forms F Show reports of all Centre immediately Display count display all pseudonyms Style definition of the odd rows lt Please choose gt E Please choose gt el Preview rows even rows lt Please choose gt Preview Statusfield completion status Display Y fT Text if data ent complete 22 isset 2 style areena 2 2 Text if Pcompletelyfiled isst style buebbo A o fs Text if partyfiled Je isst z style buedbo PRO ve a Text if empty is set z style blue2bg Preview Delete Empty column Cancel Save and back Save top Fig 61 Editing a status reports in this case the completion status see Fig 60 The upper part of the page lists all reports created for this project Clicking onto a name loads the report into the lower part of the page
184. s The arithmetic operator of the first AND condition is used as the arithmetic operator arith metic operator for the OR group Example Type Calculate score from Rule name Sequence position 10 Parameters for the calculation ignore this value during calculation calculate only when maximum number of this uncounted values post decimal positions D Rule conditions 3 Position Error message Operator Comparison value Question Delete from database 10 10 add value ltem lt zal gt or 20 10 and subtract value Item lt za2 gt Fig 50 Definition of a score calculation with bracketing via an AND group The above definition produces the calculation A B Calculate score from This function only enables the execution of simple additions subtractions multiplications and divi sions Which number is not to be taken into consideration in the calculation e g don t know 9 can be defined in advance so that only sensible answers are used So that a minimum number of input values can be demanded for the calculation the number of un counted values only for which the calculation is to be carried out can additionally be specified This specification will be treated analogously to possible preconditions Calculate normed score from On calculation of the normed score the result of all operations is automatically divided by the num ber of calculated values calculated values are all values which do
185. s Method of Test or Examination Char perm Record Qualifier munoassay ELECTROPHORESIS DIPSTICK EGNAM yes __Laboratory Vendor Name Char perm Record Qualifier Dr S ore vendor 8 9 laboratory tat provided the EGXFN yes External Filename Char perm Record Qualifier Filename for an external file such as one for an ECG waveform or a medical image Variable Qualifier of Standardized units used for STRESC and STRESN Example EGSTRESU yes Standard Units Char perm STRESC and STRESN mol L aerate Used for continuous or numeric results or findings in standard EGSTRESN yes RUMENE PESUWUP IDANE n Num perm Result Qualifier format copied in numeric format from STRESC STRESN Standard Units Fass should sto re all numeric test results or findings Contains the result value for all findings copied or derived from ORRES in a standard format or in standard units STRESC sho uld store all results or findings in character format if results are nu Result or Finding in Standard De meric they should also be stored in numeric format in S TRESN ESPTIRESO Ves Format opar 18 p Result Qualiter For example if various tests have results NONE NEG and NEGATIVE in ORRES and these results effectively have the same meaning they could be represented in standard format in STRESC as NEGATIVE EGOR im a Variable Qualifier of f RESU yes Original Units Char perm ORRES Unit for ORRES Examples IN LB kg L Result or Finding in Original pus
186. s in a form generic reports and statistics which depict individual statuses or values from several patients togeth er can be created in secuTrial Like the form description the reports and statistics are also defined for each project in the Form Builder whilst the data are displayed in the DataCapture As the forms are compiled generically via variable definitions it is also necessary to create the evaluating reports and statistics generically Reports and statistics differ in four ways as regards the evaluation and portrayal of the data 1 Summarisation of patients 3 Patient sums are always displayed in the case of statistics Reports list each patient individu ally 2 Filtering patients Statistics always evaluate all patients from all centres reports usually filter the centres limita tion possible with SQL reports according to the current participant s access rights The patient status is disregarded in statistics i e patients which have been marked as To be deleted or have already been anonymised are also evaluated These patients are not displayed in reports Exception Patients entered in an administrative centre AdminTool are disregarded in the re ports and statistics 3 Display Statistics are displayed as graphics Reports usually consist of text based lists of data excep tion Icon report image form report 4 Up to dateness Statistics are generated once per night configuration of the generation
187. s is set to Deceased The forms are frozen for editing Casenode forms All item components except DB Dummy Layout Dummy and all calculable items without entry Score Date Interval Date section Depending on field type Action Saving revalidation No effect Yes mnpcs2 is set to 1 No None in the own form On meeting one of the defined conditions the patient status is set to Freeze The forms can no longer be edited Casenode forms All item components except DB Dummy Layout Dummy and all calculable items without entry Score Date Interval Date section Depending on field type Action Saving revalidation No effect Yes mnpcs1 is set to 1 No Initially none in the own form On meeting one of the defined conditions the patient status is set to To be deleted The forms are frozen for further editing When logging in next the patient can no longer be edited at all he is no longer listed or found Further consequences should be Deletion of the patient including all medical data Patients with this status are also no longer found or exported by the ExportSearchTool Casenode forms if the patient has completely withdrawn his consent Calculate score from Can be applied to Condition Type Check Form status Casenode status Error message Effect Score Fields from which the value is to be calculated Action Saving revalidation button Completion status following calculation Atte
188. sage is triggered more than once Note because the sending action itself is not recorded the currently defined trigger will be searched for in the Audit Trail If this already exists the message will be considered to have been sent out again Patient The availability of pseudonyms depends on the project and customer configuration Pat ID Only configurable when using the Pat ID in the project Add ID Only configurable when using the Add ID in the project Lab ID Only configurable when using the pseudonym display in the customer URL for the patient If this option is selected a URL for directly accessing the patient is included in the mes sage Form The form entries can only be selected if the message is triggered during form editing SDV items Only configurable for SDV messages By selecting this option items which reset the SDV status when edited are also listed in the message Query item Only configurable for query messages This option includes the queried item in the mes sage Query text Only configurable for query messages The current query entry is included in the mes sage URL for the form Cannot be configured when creating a patient or empty visit messages By selecting this option a URL for directly accessing the form is included in the message By clicking the URL in a message for directly accessing patients or forms the URL is called up in the browser e mail programme function alter
189. scription Method of Test or Examina Ed Method of the test or examination Examples EIA Enzyme Im MSMETHOD Yes lien Shay EXP BEER QUITE munoassay ELECTROPHORESIS DIPSTICK MSNAM yes Laboratory Vendor Name Char perm Record Qualifier Name or identifier of the vendor e g laboratory that provided the test results MSBLFL yes Baseline Flag Char perm Record Qualifier Indicator used to identify a baseline value Should be Y or null Result or Finding in Original des Result of the measurement or finding as originally received or col MSORRES yes Units Char exp Result Qualifier lected Examples 120 lt 1 POS Used to indicate a derived record e g a record that represents MSDRVFL yes Derived Flag Char perm Record Qualifier the average of other records such as a computed baseline Shoul d be Y or null MSSCAT yes Subcategory Char perm Grouping Qualifier Used to define a further categorization of CAT values Name of Measurement Test Synonym Qualifier of Long name For TESTCD Examples Platelet Systolic Blood MIES YES or Examination enat g TESTCD Pressure Summary Min RR Duration Eye Examination MSDTC yes Date Time of Collection Char perm Timing Variables Collection date and time of an observation represented in ISO 8601 character format Description of the fixed reference point referred to by ELTM MSTPTREF yes Time Point Reference Char perm Timing Variables TPTNUM and TPT Examples PREVIOUS DOSE PREVI OUS MEAL MSCAT yes Cat
190. scription RFS TDTC and RFENDTC in Demographics Description or date time in ISO 8601 character format of the spon SUSTTPT yes Start Reference Time Point Char perm Timing Variables sor defined reference point referred to by STRTPT Examples 2 003 12 15 or VISIT 1 a Identifies the end of the observation as being before or after the SUENRTPT yes S gt RICO Te Char perm Timing Variables sponsor defined reference time point defined by variable ENTP E SUDOSFRM yes Dose Form Char perm Variable Qualifier of DOSE Dose form for the treatment Examples TABLET CAPSULE SUDOSU yes Dose Units Char perm Variable Qualifier of DOSE E vP OSE DOSTOT oo DOS VAT Examples ngmg ae A Dosing information collected in text form Examples lt 1 per day SUDOSTXT yes Dose Description Char perm Record Qualifier 200 400 Not populated when DOSE is populated oe Synonym Qualifier of TRT If the value for TRT TERM or ORRES is modified for coding SUMS yS Mecca Name Char perm TERM or ORRES purposes then the modified text is placed here The topic for the intervention observation usually the verbatim SUTRT yes Name of Treatment Char req Topic name of the treatment drug medicine or therapy given during th e dosing interval for the observation SUDOSE yes Dose Num perm Record Qualifier oe of TRT given Not populated when DOSTXT is popu SUCLASCD yes Class Code Char perm Variable Qualifier of TRT Used to represent code for CLAS SUCLAS yes Class
191. se Form Char perm nee Ghalingr or Dose form for the treatment Examples TABLET CAPSULE Standardized or dictionary derived name of the topic variable i TRT or the modified topic variable MODIFY if applicable Eq CMDECOD yes atl hac Treatment Char perm Synonym Qualifier of TRT uivalent to the generic drug name in WHO Drug or a term in SNOMED ICD9 or other published or sponsor defined dictionar ies E qe Dosing information collected in text form Examples lt 1 per day CMDOSTXT yes Dose Description Char perm Record Qualifier 200 400 Not populated when DOSE is populated n Synonym Qualifier of TRT If the value for TRT TERM or ORRES is modified for coding CMMDPIPY DES Modtled Name Char perm TERM or ORRES purposes then the modified text is placed here CMTRT yes Name of Treatment Char req Topic The topic for the intervention observation usually the verbatim Variable Prefix Variable label Type Core Role Description name of the treatment drug medicine or therapy given during th e dosing interval for the observation CMDOSE yes Dose Num perm Record Qualifier stl of TRT given Not populated when DOSTXT is popu CMCLASCD yes Class Code Char perm Variable Qualifier of TRT Used to represent code for CLAS CMCLAS yes Class Char perm Variable Qualifier of TRT eee medication or treatment often obtained from a coding CMINDC yes Indicatio
192. ses Groups together expressions to force a sequence of evaluation For example the expression 1 2 3 yields the result 7 whereas the expression 1 2 3 yields the result 9 Additional arithmetic operators are x y addition Add x and y x y subtraction Subtract y from x x y multiplication Multiply x and y x y division Divide x by y x y exponential pow Raise x to the exponent y e x y modulo Produces the remainder of the division of x by y Examples Level for the item Gender which is coded with male 0 and female 1 value 0 value 1 Level for a measurement value item which is entered as a number with 3 decimal places value 2 value gt 3 14 Level for the item year of birth which is entered as a year value lt 1950 value gt 1950 AND value lt 1960 value gt 1960 Information on the randomization basis For randomizations using a minimization algorithm or the extended stratified block without lists sec uTrial algorithm the randomization information used as the basis for the randomization is now addi tionally saved as an entry in the database Tpxrandomize randominfo Displaying this information has not yet been implemented Example minimization with omission of the tuple list Parameter stratification factors Age Age gt 27 AND Age lt 32 Age gt 33 AND Age lt 38 Age gt 39 AND Age lt 44
193. si n 74 3 5 Compare value textforMat oooooccccccococccccononcnnccconncnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnenenininns 74 MISIU TYPOS eii a dc dla 77 AN O A a AA O 77 Az ICXIDIGSVIS tii e Oe ect tale as Aas ANd ai y ate 17 43 Pee MiS is dd ore wt 77 AA Unscheduled visit ressens tia ita ios tats 77 Report PES teclado dd dica tera 78 Di SOU eck eect EEA AT eee Sentosa eet ede sear eden ed eevee her ite cine Gietenaat ss 78 DB functions lb ld deeds diia 82 02 HEPES SOL a A A a E LA A A aa id ca 84 Did Simge Tela A A ai 85 5 4 Single field per VISTE arcilla dalla 86 AMS it o A A A A 87 O O O E 87 Commipletion SAUS A ri 88 a cA ca BN tet cat agate 88 COMME Si iS O e A A 89 Source Data Verification SDV reregedan E AE ATOA 89 9 6 Query detal snina a AE EA EE R E E E E idas 89 o Endep a a E E EEA AS Gap eeescnne ee a Neate 90 De maga OIME oss a a a EEE OEA A A AE E E 91 DF Malidation Error Tepe a it aN EE 92 Dlatistics POS A AEEA OE 94 Oi E ON 94 6 2 Evaluated NIOM a O a a a E aE Ne iaa EEs Aaa aa TE 96 REAREN E EE E E A T A E E ace E A 96 Datamelds tr a a a a E r eS 96 6 3 ConfiguratiOn OPTIONS estoicos EEA E O EAE R 97 Message S iaa 99 7 1 Types General setings arnei eaaa a AE E A EAr NA AR ARTTA 99 Li2 Project massage Sea a E E ERO T 101 Bundled Messages iii A aE Er OSE 101 Not bundled Messages oce ondre e AR E adn Lavine REA 101 13 PONMMESSAGCS ii A ATER 102 7 4 Randomization Messages enre eoan r a a n
194. splay all pseudonyms Style definition of the odd rows arayba rows even rows lt k Please choose gt choose gt y Preview Form Personal Data lt mnpprobpersdata gt Item Patient description 1 Weight lt weight gt display unit Style definition of the lt Please choose gt gt Preview column if gt z 100 0 then use redbg style Preview Empty column Fig 58 Configuration of the single field report from Fig 57 in the FormBuilder To do this the form field and the limit value are additionally selected after specifying the Single field report type For this report the limit value has been specified as 100 All values above this are emphasised in red The defined unit is displayed in this report 5 4 Single field per visit As a refinement of the Single field report a different field for portrayal can also be selected for each visit In this case the same data can be input as in a single field report A heading can additionally be defined for each field Close 31 08 2010 19 46 CEST Print 7 e rticipant Dipl biol Susanne Schneider SOCUINAL cee nets isa exa Multiple values Y Centre A No patients included Y Centre B 1 visit 2 visit 3 visit Pat ID Birthdate Sex Weight Weight Weight ick371 A 12 02 1982 female jqj789 17 06 1964 male 123 2 kg E ee ee A pxel46 xel012 01 05 1976 female 75 4 kg xkx764 76 0 kg Fig 59 Example of th
195. ssages please note that both the sending and receiving e mail servers may have restrictions on the size of e mails This limit can soon be reached even when sending multiple small image files You can define multiple messages as a follow up action This enables different messages to be con figured for different form actions e g when entering form data select completion status as the trig ger or for monitoring select form status as the trigger Conditions Messages Message Nachricht aus Visite Folgeaktion lt completion status gt Message Interner Titel lt completion status gt New notification Fig 78 List of all form messages on the form editing page 7 4 Randomization messages In addition you can define a message inside the Configurable Randomization Button item as another message type You can set the message to be triggered directly with the randomization of a patient or depending on the number of possible randomization options remaining The message will then be sent if the exact amount of entries is available for each randomization group with necessary centre affiliation also per centre 7 5 Rule messages As with form messages additional questions and pictures from the actual form or questions and pic tures from other forms and or visits can be included and sent in this message type see Form mes sages 8 1 secuTrial database structure Essential project tables Centre ctrid Patient pid P
196. ssibility to enter html e g bold a Horizontal Radiobutton with not applicable C yes Cno reset option b Textfield co Fig 4 Example of an ASStandardGroup with two items Consistency check Non productive Can be changed to IASUnitGroup or lIASHorizontalUnitGroup as long as there are no items on saving the two mandatory fields number field and unit list are then created automatically lASStandardGroup with only one radiobutton or check box can be changed to a RB matrix or check box matrix lASStandardGroup with lookup fields only not with extendable lookup fields can be changed to an IASMultipleSelection ASCombinedSelection or ASHorizontalCombined Selection Productive Can be changed to lASHorizontalGroup lASAlternateStandardGroup Except catalog fields all item types can be created IASAlternateStandardGroup The IASAlternateStandardGroup offers a slightly different design than the IASStandardGroup The portrayal of the items which are contained begins directly behind the question s number label the item text is displayed above the item input fields All of the question s items are portrayed beneath one another on the whole E This component can be used e g if a very large image see below or items with very wide input fields are to be displayed in the form This component extends the option of structuring the layout of forms Image form Please upload the
197. t family forms are displayed according to the assignment of rights and the configured work flow The AE SAE work flow is explained in greater detail in the FormBuilder user manual For the labelling of adverse event forms all contained form items which do not originate from a repetition group can be selected The corresponding item value of the saved form will then be displayed in the overview instead of the form name If no value has been entered for an item the form name will continue to be displayed Casenode The casenode family contains all forms which have to be completed once for each patient irrespective of date e g final reports It can be created exactly once The family is displayed on the patient form overview behind the AdverseEvent tab if available the family name serves as the tab label in this case The family forms are displayed according to the assignment of rights and are all listed below one another Image The image family contains forms which can be optionally created As it has been created to display images larger icons with a form thumbnail are displayed instead of the normal form icons This family can be created exactly once The family is displayed as the last tab in the patient form overview the family name is also used as the tab label in this case Like AEs SAEs image forms are created via a New image form link and can then be assigned to either a patient a visit or an AE SAE examination The fo
198. t possible to enter a relative visit because no currently edited visit exists for the other patients With these algorithms for the stratification factors an absolute visit must be selected from the project visit templates If the visits can be created multiple times the first chronological visit of the selected type will always be evaluated for the stratification If the stratification factor for a randomization button is determined in a randomization form it will not be possible to enter the visit For the current patient the factors will then always be determined by the current entry in the current form For all other patients the value will be evaluated from the first chronological visit of the current visit type Factor level definition For item stratification factors at least one factor level must be defined The levels are formed from logical expressions and each current value of the patient is represented in the expression by the term value Capitalizations of value and empty spaces before or after the operator are ignored The database equivalents of each item are to be entered as comparative values Radiobuttons and pop up items for example are to be entered with the DB values Fixed comparative texts are to be enclosed in single apostrophes or double quotation marks With numbers decimal points are to be entered with a period secuTrial date items are saved as text in the format YYYYMMDDHHMMSS Empty spaces must be entered
199. te a derived record e g a record that represents LBDRVFL yes Derived Flag Char perm Record Qualifier the average of other records such as a computed baseline Shoul d be Y or null a ate Collection date and time of an observation represented in ISO LBDTC yes Date Time of Collection Char exp Timing Variables 8601 character format LBENDTC yes End Date Time of Observation Char perm Timing Variables ee pl mieronee Wallon TEPES EMEN INSO BENI aras Text description of time when a measurement or observation i iea should be taken as defined in the protocol This may be represen al yes FATE ine Folie name nal Berar biming Mariables ted as an elapsed time relative to a fixed reference point such as time of last dose See TPTNUM and TPTREF LBTPTNUM yes Planned Time Point Number Num perm Timing Variables Numeric version of planned time point used in sorting Planned Elapsed time in ISO 8601 character format relative to a Planned Elapsed Time from planned fixed reference TPTREF such as Previous Dose or LBELTM yes i AD Char perm Timing Variables Pre vious Meal This variable is useful where there are repetitive Time Point Ref e E s measures Not a clock time or a date time variable but an interva represented as ISO duration Description of the fixed reference point referred to by ELTM LBTPTREF yes Time Point Reference Char perm Timing Variables TPTNUM and TPT Examples PREVIOUS DOSE PREVI OUS MEAL LBSCAT yes Subcateg
200. ted by the preconditions However score rules will be evaluated in a preliminary step before evaluating the data check rules regardless their se quence and display in the form This ensures that the rules for checking the calculated score values can always be correctly evaluated When defining multiple score rules for an item all these rules will be executed but only the value cal culated last will be saved If according to the preconditions no value can be calculated for score rules the score value will be reset to NULL Scores can be calculated via number items fixed decimal places or also radiobuttons and pop ups as the DB values are then used as data If the conversion factor is also set in the case of a label in addition to the DB value this is used for calculation instead of the DB value Scores are calculated with the accuracy which can also be input by the user in the evaluated items If the user is able to specify three post decimal places the score is also calculated to three post decimal places A normed score and a function score however are always calculated to an accuracy of two decimal places see Score only calculated When defining the score rules you can also specify the accuracy by entering the number of decimal places The calculation will then be rounded to this number of decimal places When defining multiple score rules with different accuracies on an item the maximum size of the minimum and maximum precision of
201. terva represented as ISO duration Contains the result value for all findings copied or derived from ORRES in a standard format or in standard units STRESC sho uld store all results or findings in character format if results Result or Finding in Standard e are numeric they should also be stored in numeric format in S MSSTRESE yes Format Ghat Esp Result Qualities TRESN For example if various tests have results NONE NEG and NEGATIVE in ORRES and these results effect ively have the same meaning they could be represented in standard format in STRESC as NEGATIVE a ae Used for continuous or numeric results or findings in standard MSSTRESN yes unete Resul naing n Num exp Result Qualifier format copied in numeric format from STRESC STRESN Standard Units ware should sto re all numeric test results or findings A Variable Qualifier of Standardized units used for STRESC and STRESN Example MSSTRESU yes Standard Units Char exp STRESC and STRESN mol L Synonym Qualifier of Logical Observation Identifiers Names and Codes LOINC code MSLOING YSS BOING Code Char perm TESTCD for the topic variable such as a lab test Variable Qualifier of Used to categorize the result of a finding Example MALIGNANT MORESCAT yes i ResulbGalegory Char xP ORRES or BENIGN for tumor findings MSORRESU yes Original Units Char exp E of Unit for ORRES Examples IN LB kg L PC Pharmacokinetic Concentrations Findings General Obs
202. the calculation is calculated for the entire via all of the score rules for that item The mathematical portrayal of the desired functions and processing in the programme deviate slightly The score always operates according to the following pattern result result op parameter whereby op refers to one of the following operators Add value Subtract value Multiply by value and Divide by value This operation is carried out for each parameter This results in a type of bracketing start with result 0 result 0 op parameter1 op parameter2 op parameter3 Parameter refers to the value which is read out from the specified field Assume that we have the following questions Is the sky blue yes 1 no 0 Is the sun shining yes 1 no 0 Are the flowers in bloom yes 1 no 0 And the score is intended to provide a type of assessment of how good the weather is by calculating the sum of the questions from Number of Yes in sky sun flowers A simple score with three parameters would then be created Parameter 1 Add value read out value from question Is the sky blue Parameter 2 Add value read out value from question Is the sun shining Parameter 3 Add value read out value from question Are the flowers in bloom For the calculation of scores the AND conditions can be used as a bracketing level When calculat ing scores all of the AND conditions in a group will first be applied before the application of the OR group
203. the function feeds back ss A For the following functions the tpxdocument has to be replaced with the name of the corresponding project table The other labels in single quotes are examples and can be replaced VISIT_COMPLETION tpxdocument cvpid visitid empty partial complete Summarizes the completion status of the visit defined by cvpid and visitid As a result one of the given labels is returned VISIT_DEC_COMPLETION tpxdocument cvpid visitid empty partial complete finished Summarizes the completion status of the visit defined by cvpid and visitid As a result one of the given labels is returned If the status DEC is set in all forms the finished label will be re turned regardless of the stored completion status of the forms VISIT_FAMILY_COMPLETION tpxdocument cvpid visitid form family empty partial complete Summarizes the completion status of the visit formfamily defined by cvpid visitid and family name As a result one of the given labels is returned VISIT_FAMILY_DEC_COMPLETION tpxdocument cvpid visitid form family empty partial complete finished Summarizes the completion status of the visit formfamily defined by cvpid visitid and family name As a result one of the given labels is returned If the status DEC is set in all forms the finished label will be returned regardless of the stored completion status of the forms
204. the visit date The option of inserting unscheduled visits between the normal scheduled visits also exists A patient s scheduled visits are numbered in the sequence of their creation The unscheduled visits are numbered individually by type also in the sequence of creation If permitted the chronological sequence may deviate from the numbering 7 All visits are always displayed in chronological sequence in the patient s form overview 4 1 Fixed visit In the case of fixed visits the point in time of the visit is calculated from the specified data The participant cannot input a date The calculation is based on the date which was input in the reference visit All of a visit plan s initial visits must be fixed or flexible visits 4 2 Flexible visit In the case of flexible visits the possible deviation upwards and downwards from the calculated point in time must be specified in addition to the planned interval 4 3 Free visit m In the case of free visits there is no planned interval from other visits and therefore also no preced ing visit However the visit date can be restricted by specifying a time span this is not then com pared with the calculated date but with the current date 4 4 Unscheduled visit Unscheduled visits can be created outside of the specified visit plan They are skipped on calcula tion of the next scheduled visit even if Preceding has been entered as the reference visit for the next scheduled
205. time per installation Reports are created in the case of the current display and therefore show the respective data status at the point in time of the view 1 5 Form family types Forms are organised in form families In this case the form family type defines the display and function of the forms which are contained Each family may contain any number of forms Only precisely one copy of certain family types can be created Visit This is the standard type for normal study eCRFs Any number of families can be created for this type Visit families are displayed in the patient form overview on the first tab in this case the families are depicted beneath each other to form the verticalaxis The family names are displayed on the outer left The display of forms which are contained is determined apart from the assignment of rights by the forms inclusion in the visit plan AdverseEvent This family contains the forms for the AE SAE work flow It can be created exactly once the AE SAE work flow for this project is only configurable if an AdverseEvent family exists The AdverseEvent family is displayed on the patient form overview on the second tab The family name is used as the tab label in this case In the case of created AEs the tab is emphasised in colour in the case of a created SAE the coloured marking is more intensive and the patient form overview is always opened in this tab when calling the patient up The AdverseEven
206. tion Result or Finding in Original es Result of the measurement or finding as originally received or col LBORRES yes Units Char exp Result Qualifier lected Examples 120 lt 1 POS LBORRESU yes Original Units Char exp e ot Unit for ORRES Examples IN LB kg L Normal Range Lower Limit Ori Variable Qualifier of Lower end of normal range or reference range for results stored in LBORNRLO yes ginal Units Char jexp I ORRES ORRES LBORNRHI yes Normal Range Upper Limit Ori Char exp Variable Qualifier of Upper end of normal range or reference range for results stored in Variable Prefix Variable label Type Core Role Description ginal Units ORRES ORRES Contains the result value for all findings copied or derived from ORRES in a standard format or in standard units STRESC sho uld store all results or findings in character format if results are Result or Finding in Standard numeric they should also be stored in numeric format in S EBS TRESS Yes Format Char Exp Pesut curalimgr TRESN For example if various tests have results NONE NEG and NEGATIVE in ORRES and these results effectively have the same meaning they could be represented in standard format in STRESC as NEGATIVE Numeric Result Finding in Used for continuous or numeric results or findings in standard LBSTRESN yes 9 Num exp Result Qualifier format copied in numeric format from STRESC STRESN Standard Units
207. tion for a specified text format of 5 lower case letters The format for permissible text inputs can be defined here When completing the form only the text which corresponds or does not correspond depending on the condition definition to this format can be input The needed format is added automatically to the specified error message The format defines how long the text may be and how it is compiled from capital or small letters and numbers The format is specified via individual characters The characters stand for the following in this case Character Letters and numbers c 1 arbitrary letter L 1 small letter U 1 capital letter N 1 individual number A 1 letter or a number As before but optional c 0 1 letters l 0 1 small letters 0 1 capital letters 0 1 individual numbers 0 1 letters or numbers v5 c Place holder 1 or more arbitrary characters Special characters 1 hyphen 1 point 1 underscore 1 colon and other special characters Format examples CCCCCC 6 arbitrary letters LLLLLL 6 small letters LLLNNN 3 small letters followed by 3 numbers CAAAAA 6 letters or numbers no number is permitted at the beginning UNNnnn 1 capital letter followed by 2 5 numbers UU Nnn 2 capital letters followed by 1 hyphen followed by 1 3 numbers C 1 letter followed by arbitrary characters z A project s visit plan can be compiled from different visit types which differ as regards the calculation and flexibility of
208. to Trace Used to indicate the value is outside the normal range or refer LBNRIND Es Normal Reference Range In Ghar lex Variable Qualifier of ence range May be defined by ORNRLO and ORNRHI or oth y dicator p ORRES er object ive criteria Examples Y N HIGH LOW NORMAL AB NORMAL LBNAM yes Laboratory Vendor Name Char perm Record Qualifier Name or identifier of the vendor e g laboratory that provided the test results Variable Prefix Variable label Type Core Role Description Synonym Qualifier of Logical Observation Identifiers Names and Codes LOINC code EELOING aves ERING Code Char pen TESTCD for the topic variable such as a lab test 7 a Defines the type of specimen used for a measurement Examples LBSPEC yes Specimen Material Type Char perm Record Qualifier SERUM PLASMA URINE LBSPCCND yes Specimen Condition Char perm Record Qualifier Defines the condition of the specimen Example CLOUDY po a Method of the test or examination Examples EIA Enzyme Im LBMETHOD yes Method of Test or Examination Char perm Record Qualifier munoassay ELECTROPHORESIS DIPSTICK LBBLFL yes Baseline Flag Char exp Record Qualifier Indicator used to identify a baseline value Should be Y or null P Indicator used to identify fasting status Valid values include Y N LBFAST yes Fasting Status Char perm Record Qualifier Uor null ithotrelevant Used to indica
209. to indicate the pattern of the event over time Examples IN AEPATT yes Pattern of Event Char perm Record Qualifier TERMITTENT CONTINUOUS SINGLE EVENT sl Description of the outcome of an event Examples AEOUT yes Outcome of Event Char perm Record Qualifier RECOVERED RESOLVED FATAL del Was the event associated with the development of cancer Valid AESCAN yes Involves Cancer Char perm Record Qualifier values are Y and N Congenital Anomaly or Birth a Was the event associated with congenital anomaly or birth defect AESCONG yes Defect Char perm Record Qualifier Valid values are Y and N AESDISAB yes Persist or Signif Disability In Char perm Record Qualifier Did the event result in persistent or significant disability incapacity capacity Valid values are Y and N AESDTH yes Results in Death Char perm Record Qualifier Did the event result in death Valid values are Y and N AESHOSP yes Requires or Prolongs Hos Char perm Record Qualifier Did the event require or prolong hospitalization Valid values are pitalization Y and N 9 j i Ww AESOD yes Occurred with Overdose Char perm Record Qualifier No aren An E E A AN AESMIE yes Other Medically Important Char perm Record Qualifier Do additional categories for seriousness apply Valid values are Serious Event Y and N Concomitant or Additional a Was another treatment given because of the occurrence of the PECONTRE YES Trtmnt Given Ghar penn Record QUANG event Valid values a
210. tor again and displayed in the input field IASUnitGroup Comment Measured value 5 ko 5 000 000000 g Query Measure done Cyes Cno Time of measure J hh mm Fig 20 Example of an IASUnitGroup with the three units mg g reference unit and kg and two additional items So that the user knows what he is actually saving the database value is also additionally displayed in the reference unit if he has not selected the reference unit Due to this type of handling the data base values are all directly comparable without further conversion On creation of an IASUnitGroup the two necessary items and a supplementary set of rules are already created during the first save The database columns are designated with a standard value and a standard reference unit is created The units then have to be correspondingly exchanged and supplemented according to the relevant requirements The columns can be renamed following cre ation These items are created even if another empty question is converted into an IASUnitGroup Due to possible rounding errors the IASUnitGroup should only be used with reservation an E sig nature should generally be used here with care Additional items can also be defined in any sequence in an IASUnitGroup in turn their types can be freely selected from text fields date fields check boxes or radiobuttons Further options include Attention lookup tables and score fields However deleting the individual pop
211. type see below Consistency check Can be created in lASStandardGroup lASAlternateStandardGroup lASHorizontalGroup ASUnitGroup and lASHorizontalUnitGoup Non productive as long as an item has not been set to productive it is possible to change the component type between Time and checked Time even if the item has been assigned rules Productive Can be changed to time or checked time in which the information content is at least as large as in the productive version l e Time HH MM can be changed to Checked time HH MM SS but no longer to Checked time MM SS Date The date field is required e g in the question regarding the date of birth Which scope and which format the date is to have are specified in the type selection with the letters Y M and D for year month and day As with time fields you can define with this item type whether the formatting display should be shown next to the entry fields The following options can also be selected here display hide display with optional fields In the database date formats are handled as texts with a length of 14 characters with the format YYYYMMDDHHMMSS year month day hour minute second There are therefore no text fields with a length of 14 Non input fields are filled with blanks On export the output is usually shortened to the input format Personal Data Date of birth i J dd mm yyyy Comment 5 Query Birth place Fig 36 Example o
212. up or number items is not pos sible even after creating new items in an ASUnitGroup and the question is not productive Consistency check Non productive Productive Can only be changed to lASHorizontalUnitGroup All items except number popup randomization buttons and catalog fields can be created as additional items The two unit items cannot be deleted even when they are non productive In the sequence the unit pop up is always positioned directly behind the unit number field IASHorizontalUnitGroup Operates precisely like the IASUnitGroup with the difference that several elements are arranged next to each other and not beneath each other Additional items are portrayed in the specified sequence in front of or behind the two unit fields ASHorizontalUnitGroup Comment Quer Measure done Measured value Time of measure y Cyes Cno lt Please choose gt Y hh mm Fig 21 Example of the view of an IASHorizontalUnitGroup with two additional items Normally the items are distributed evenly according to their number over the width of the page with 3 items each item therefore takes up 1 3 of the width of the page A flexible column width can be configured instead the items are then arranged directly behind each other and are not distributed over the width of the page Consistency check Non productive Productive Can only be changed to IASUnitGroup All items except numbers popup rando
213. us is OK the SELECT statement has been correctly edited by the database If an error occurred the error message generated by the database is displayed beneath the listed report and the data can be corrected accordingly As additional information the contained number of lines is specified in the wait window on completion of the SQL query The test result will be saved until the next time the report is edited If you change the report or simply save it again then you must repeat the status test When designing an SQL report make sure that valid table links are created An unintentional cross product may block the whole database The validity check for SQL report is therefore only carried out on request and not automatically as in the case of the other types In addition to the selected column a DISTINCT may also be specified in the definition of the first output columns Knowledge of the database structure is necessary to formulate a correct SQL statement This does not correspond to the exported data structure For a description of the individual database tables please refer either to the database descriptions which can be downloaded in the CustomerAdminTool The relationships between the most important project tables are described in the graphics in the Annex There is also a clickable i icon next to all text fields which enable such elements By clicking the icon a pop up help window will open which describes the database structure
214. usly If no rigidity is detected use an activation maneuver such as tapping fingers fist opening closing or heel tapping in a limb not being tested Explain to the patient to go as limp as possible as you test for rigidity Neck RUE LUE RLE LLE O C C C Normal No rigidity C C C C C Slight Rigidity only detected with activation maneuver C c cc c Mi ae detected without the activation maneuver but full range of motion is easily achieved C C C c c Moderate Rigidity detected without the activation maneuver full range of motion is achieved with effort C c cc c HAE REN detected without the activation maneuver and full range of motion not achieved Fig 12 Example of an ASVertRBMatrix consisting of five items Consistency check Non productive Can be changed to ASHeadline items are deleted IASHorizRBMatrix IASStandardGroup IASAlternateStandardGroup IASHorizontalGroup Productive Can be changed to IASHorizRBMatrix ASStandardGroup IASHorizontalGroup Only horizontal radiobuttons can be created IASCheckboxMatrix In principle the IASCheckboxMatrix functions like a horizontal radiobutton matrix Several questions with the same answer options which are to be portrayed as check boxes i e multiple selection possible can therefore be presented in compact form The answer texts should be short in order to fit into the columns 1A SCheckboxMatrix Drug usage Comment Please check all that applies
215. ust then be carried out in the individual case to determine which of the two is more sensible The rule that an input in the Pregnant field in form A is only possible if Female has previously been selected as the sex in form B is to be created This could be defined in two ways which differ above all as regards the handling of an unsaved form here B Note 1 Input only possible if sex female in form B An input is therefore only possible if the item in form B has exactly this value If form B is not saved there is no value for sex and the condition is not met 2 Input impossible if sex lt gt female in form B An input is not therefore possible if the sex in form B has a value other than female If form B is not saved there is no value for sex and the condition is met NULL lt gt female If rules of an item X refer to the completion status of another item Y it is no longer possible to delete item Y or the form which contains Y The DELETE button will be replaced by the message Not de letable because of references Via this message you can access a pop up window to view the origin of the references Rules can be ordered according to the following effects certain rules fall into several categories in this case Generic Assembling of Input Interface The rule hide if results in a dynamic adaptation of the current form according to already stored or currently entered form values The evaluation of the rule con
216. visit So that this visit type can also be used for alternative treatment plans however the interval from the preceding visit plus an optional time window can also be specified here If no data are input these visits can be set entirely as desired 5 1 SQL Lists of various data types can be created in a report in this case This type necessitates certain knowledge regarding the secuTrial data model and SQL see Annex In contrast to the majority of others the results of the reports can be easily sorted and filtered On the other hand this type only enables an automatic test of the current participant s access rights to a limited extent It is therefore possible for a participant to view data in the DataCapture which he is not normally permitted to see due to his roles and rights 7 31 08 2010 19 24 CEST Close ig Dipl biol Susanne Schneider seculrial Study 1 31 08 2010 19 23 50 CEST Print SQL Report Pat ID can xel012 2010 08 31 No 01 05 1976 fernale xel012 2010 08 31 o 01 05 1976 female jgj789 2010 08 31 No 17 06 1964 male jqj789 2010 08 31 o 17 06 1964 male xyx219 2010 08 31 Yes 30 11 1957 male zpu265 2009 11 11 o zpu285 2009 11 11 o xkx764 2009 11 11 do xkx7b4 2009 11 11 o ick371 2010 08 31 0 12 02 1982 fernale ick371 2010 08 31 o 12 02 1982 female Fig 52 Example of the view of an SQL reports Filtering by pseudonym top drop down list and sorting according to the other data have been defined here In th
217. w of and access to all queries which have not yet been edited including across all patients Print page for paper based query answers a To support paper based query handling in hybrid studies a new print page has been added to the query report where an answer form could be printed for each open query The form automatically includes the position of the query e g visit form question and item and the current query status question possible answers and re queries Below is an empty field for writing down the answer and signature Print Paper based answers Query DCF Title lt p gt Please check the data for this query and put your answer into the secr on your answer below lt p gt lt p gt Send the dated and signed form back to your study office lt p gt a E Info text on print page HTML Context information all including visit or adverse event and document ID reduced only form family Y Signature 2 Fig 63 section for the configuration of the print page for paper based query answers This additional print function can be activated in the FormBuilder under Print paper based an swers per query report see fig 63 The following parameters can be changed Title Here you can enter the name of the answer form which will also be the name of the but ton in the query report by which the print page can be reached Info text on print page HTML Here you can configure
218. which is the verbatim or pre specified name of the event Body System or Organ Body system or system organ class from a standard hierarchy e g AEBODSYS yes Ciao gt 9 Char exp Record Qualifier MedDRA associated with an event Example GASTROINTESTIN AL DISO RDERS f a The severity or intensity of the event Examples MILD MODER AESEV yes Severity Intensity Char perm Record Qualifier ATE SEVERE AESER yes Serious Event Char exp Record Qualifier Is this is a serious event Valid values are Y and N Action Taken with Study na Describes changes made to the study treatment as a result of the AEACN Yes Treatment ener Gp RecendOualitter event Examples DOSE INCREASED DOSE NOT CHANGED AEACNOTH yes Other Action Taken Char perm Record Qualifier Describes other actions taken as a result of the event that are unre lated to dose adjustments of study treatment Records the investigator s opinion as to the causality of the event to AEREL yes Causality Char exp Record Qualifier the treatment ICH E2A and E2B examples include NOT RELATED UNLIKELY RELATED POSSIBLY RELATED RELATED Relationship to Non Stud An opinion as to whether the event may have been due to a treat AERELNST yes p Y Char perm Record Qualifier ment other than study drug Example MORE LIKELY RELATED Treatment TO ASPIRI N USE Variable Prefix Variable label Type Core Role Description na Used
219. without entry Score Date Interval Date section Depending on field type Form status Saving revalidation Completion status after input No effect Yes default Input required A user input in this field is vitally necessary if one of the defined conditions is met The error message is displayed to the user and the user cannot save the form until he has either entered any data or switches off the check Conditional mandatory fields for important information Input required or ignore completion status if Can be applied to All item components except DB Dummy Layout Dummy and all calculable items without entry Score Date Interval Date section Condition YesDepending on field type Type Form status value range Check Saving revalidation Form status After condition and input if the condition is met after input if the condition Casenode status is not met the item is regarded as complete No effect Error message Yes with fulfilled condition and missing value default Input required Effect Combines a mandatory entry field with an effect on the completion status It can be defined in just the same way as an Input only possible if rule Usage Conditional mandatory fields for important information Input only possible if Can be applied to Condition Type Check Form status Casenode status Error message Effect Usage Comment
220. y Categories summarise several statistics which are connected to each other E g several charts referring to hepatic values may be assigned to the Hepatic values category Depending on type the category s default setting is Recruitment or Data Time configuration You may choose between day month and year for the time axis subdivision This enables the statistics to be adapted to the run time of your project You can choose between various options to portray the time configuration In the case of data statistics on data in an individual visit the visit to be evaluated additionally has to be specified Earliest visit with stored form refers as the data basis to the earliest visit of the entire visit plan for each patient in which the relevant form was actually saved selection lt Visit plan gt If Latest visit with stored form has been selected of course the last visit is used for evaluation To enable the selection to be limited you may also select a concrete visit type for evaluation Evaluation Evaluation can be carried out via the cumulative or absolute frequency In the case of the cumulative frequency all results are summarised On cumulative portrayal in the case of the statistics Patients over time the number of new patients created in the 2nd month is added to the number of new patients created in the 1st month On absolute portrayal the number of new patients created is portrayed individually for ea
221. ynamically from the database contents on request This means that two central functions are therefore required for the presentation of forms 1 A module which generates an HTML page containing the form see below in the centre part from the database contents In secuTrial this module is called the FormEngine and is integrated into the DataCapture not visible to the user 2 A module with which the database fields which define the appearance of the forms can be filled and changed This module is the FormBuilder which enables the eCRF design within secuTrial secuTrial server secuTrial database Fig 1 Schematic depiction of eCRF generation In the FormBuilder the FormEngine is also used to preview the eCRF 1 2 Page structure of an eCRF in the DataCapture Date 24 08 2010 17 58 CEST Patie Pat ID pxe146 Pa 3 E Dipl biol Susanne Schneider t 02 01 2000 CET Pro Study 1 24 08 2010 17 57 29 CEST Base Examination secu ria Centre B Germany Personal Data P gt 4 Import Personal Data Birth J dd mm yyyy Comment Birth place Allergies C dog cat C house dust Sex not applicable C female C male Weight Height Pregnancy Comment lt Please choose gt Week lt Please choose gt y lIF Identification Blood sample taken Weight Height BMI Comment C J gt Score Cancel Calculate scores Save Save close entry V Check data Date 24 08 2010 CEST Clinical Investigator Dipl

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