User Manual
Contents
1. 2013 12 01 CEST Downloaded x lt l Systemtest 441 6118 CSV xls PM 02 04 2013 11 58 CEST 02 04 2013 11 58 CEST Downloaded x 1 Systemtest 441 6183 CSV xls PM 06 03 2013 12 27 CET Export completed x lt 4 Standard Test3 cSv xls PM 22 11 2012 13 39 CET 22 11 2012 13 39 CET Deleted Standard Test2 CSv xls PM 22 11 2012 13 35 CET 22 11 2012 13 36 CET Downloaded x 1 Standard Test1 O CSV xls PM 22 11 2012 13 26 CET 22 11 2012 13 26 CET Export error lt Page 1 of 1 gt Fig 20 Export history page indicating a deleted export with an error message This page contains a list of all exports including deleted exports with information on the project centre centres format participant date of creation date of the last action and status If an export was not successfully compiled an error message regarding the respective process will be displayed when the mouse is moved over the status Export error tool tip In a deleted export the error is only indicated by a red exclamation mark but you can display the error message as a tool tip in the status This page provides an overview of all requested exports and their corresponding status for projects which you are authorised to access Exports requested and or edited by other participants are also displayed here The displayed exports cannot be edited normally If the participant has the corresponding rights he can repeat exports by using the arr2. Create a search form specify the search criteria The forms displayed in DataCapture form the basis for the search The questions that are relev ant for the search are determined from the forms The search forms are always automatically saved and then further parameters can be added 2 Specify search parameters In the prepared search forms parameters can be entered and a concrete search request can then be sent to the database After the secuTrial database has been searched a list of all patients corresponding to the specified criteria will be provided The search does not reduce the volume of data per patient in the export only the selected items are transmitted in the Export but instead reduces the number of patient data sets Only patients who are included within the results lists are exported Export Exporting data entails four steps 1 Define the export criteria 2 Generate a transaction number TAN with the ExportSearchTool 3 Compile the exported data in the desired export format 4 Download the exported data with the TAN as a zip file An export can also be performed without a preliminary search In this case all of the patient data sets from the selected centre will be automatically exported 1 4 General information When searching for patients in the secuTrial database or exporting patient datasets only data will be displayed from projects to which you have corresponding access rights via your centres Dep
3. Data pool Database searches can be limited to a specific data group the Survey period only available when searching through visit forms the Form status e g don t care all active locked forms are not considered only forms that have been reviewed etc the Last edit period this means the time frame in which the data being searched was last saved the Centre select one or more centres from the list as permitted by your access rights A search for all visits is visit sensitive For example on the first visit patient X was 30 years old and weighed 100 kg On a later visit this patient was 35 years old and weighed 80 kg If a search of all visits is conducted for age 30 and weight 80 kg patient X would not be found 4 5 Search results Direct method Locin gt select a project gt select a search form gt SEARCH min Basisregister S e C ulr a l l ele CEST uj Processing search Please wait a moment until your search is completed The result will be presented to you immediately afterwards Duration of processing 00 00 Fig 7 Search in progress page Once a search has been initiated the secuTrial database will be searched according to your search criteria and parameters This can take some time depending on the complexity and the size of the selected data pool While the search is being performed the ExportSearchTool displays a processing page with a search progress bar This page has
4. the number of exported patients and visits Note Description For exports a description can be optionally entered with a maximum length of 200 characters If a description has been assigned this will be displayed instead of the centre name in the download list and the export history Project centre Any of the projects and centres for which you have access rights can be selec ted here for multiple selections use the Ctrl key Visits Select which visit dates are to be included all first last selected visits by entering the type of visit Patients Select which form datasets are to be exported all patients to be deleted patients are never exported or active patients i e not locked not deceased and not anonymous If an export has been started from a search the export is limited to the patients found in the search It is no longer possible to select projects centres or patients Instead of selected patients the number of patients found in the search will be displayed see below 09 05 2011 14 24 CEST admin a S e C ufri a Export Download Export history New export Project Basisregister Centre Berlin Visit allvisits O firstvisit C lastvisit selected visit Patients 1 Patients from search uj Format SAS format X E Ignore warnings for 262 character length since SAS 9 1 Tl Shorten table name iso 8859 15 y Character encoding Included data Patient identifier M Pat
5. Decide whether the results of the search should be stored by de activating a checkbox to the right of the SEARCH button After saving the results click on the SEARCH HISTORY button to access or reuse the search results Click on the SEARCH button to begin the search Entering search parameters For numerical data date or text fields you can choose between select absolute figures and e g date and relational figures The permitted relational operators for numerical data are gt greater than Note lt less than gt greater or equal to lt smaller or equal to lt gt unequal equal The permitted relational operators for text data are equal to lt gt unequal to contains contains With text fields you can also specify whether capitals and lower case letters should be taken into account in a search Entries in a text field are searched as complete text including any spaces contained in the entry For questions with specific answer options radio button checkboxes dropdown lists only one answer can be selected as a search parameter Image components can be searched textually for the original file name Searches for image content size or format are not possible Next to a few of the questions there is also an AND button Click on this to open an additional field where further specifications can be made for search parameters To remove them click on the cor responding DELETE button
6. User Manual secuTrial ExportSearchTool Valid for version 4 7 As of 13 10 2014 interActive Systems Berlin Vs A NN 3 1 1 Systemrequie me Sucia Ai 3 1 2 General USEF TOMAMOS ERA 3 1 3 ExportSearch Tool TUMCHONS citando a a daga can dada aora RO SERE 4 A dacnuituewaannpanidsaunania a a a a A Reads 4 A a a aa eaa E a E a a A SN 4 1 4 GeneralintomnmatioN ainda a aa a aaa a aa dba i 4 Qs LOO E O N ON 6 Ll E e e oT EE E E E EE ET O EE gagsneadaananadesaansagens 6 2 2 Change PASS WO tds 7 de Welcome paJenn teniti EE a ae e Te a a aaa aaa EEEa 8 SET A a a aaa a as aa E a ha a AAEE 8 A SCAPCN CS resm rnrn ia a 9 4 1 Search FoMSvi ica a ii dabas 9 4 2 Creating NEW Search TOMAS cid is n 10 o iis scasccte ses cetazeastuesteae inlusacesodeesuvasans vec esdgatianecgecastdeseaeavase useaddyawabaesgeouesescnemeaendeneneaaie 10 And Or criteria groups Of Criteria ooooonnnncccnnnnnniccccnnnnnccccccnconnrarn cnn ron corr rr 11 4 3 COPyINg a SEarcO TOM ios rd a lt a 11 4 4 Pertorming SEATCNOS ais sscesecutndazenekiakecisas tenet acasehewnesgenetbnanoagsteneneneaiaeiacaleauayestaaneis Rad aaa O ESAS 11 o A aha dealaundlcnesaandaiaannnaendsnsssntaenedgacesbantenganntaned cubaswenskhenlblan 12 Entering search paraMeterS cuicos ed O A 12 A ON 13 45 Searchresults cusco iaa iii 13 AO pearcei ISO isos a ro 14 9 EXPO il la don 16 5 1 Create a Mew Oxportiisia acascaconecscadedestnesndcsleweh twatdenanebtapabedeanedap
7. a Participant admin Welcome Help Logout S e C ulr a l Export Download Export history New export Project Basisregister Centre HGW Zentrurn1 1450 Visit allvisits firstvisit lastvisit selected visit Patients Valid patients C al patients Format SAS format X O Ignore warnings for 262 character length since SAS 9 1 I Shorten table name 150 8859 15 y Character encoding Included data Patient identifier M PatiD I Add 1D M Investigator and centre information M Project setup M Queries and Comments M audit Trail Double Data Entry r undisplayed duplicates I DDE notfinished yet M Form data of hidden fields Send email yes no Your email address Y Extended form filter Completion status no check empty O partly filled C completely filled gt Validation no check without with warnings Validation no check without C with errors gt Review A no check no C yes Review B nocheck no C yes gt Freeze by system no check no yes Freeze nocheck no C yes gt Comment status no check without with comment Query status no check without open C answered C resolved Query Cancel Start export Fig 10 Start page for a new export with centre selection and displayed form filter Define the criteria for the patient data and meta data which is to be exported Determine
8. all of the form tables in separate files SPSS sps a dat directory with all of the form tables in separate files CSV and text format all tables in separate files forms and sub forms in some cases the cor responding Audit Trail tables including casenodes forms items questions visit plans visit forms in some cases centres queries and or separate tables with reference values If image data has been included the folder patient images contains the image files in its sub folders Once the export has been downloaded the status of the export will change from Export completed to Downloaded The downloaded export can either remain in the list with the status Downloaded or be manually deleted via the cross button which will change the status to deleted An export can be downloaded as many times as you require using the corresponding TAN Only delete an export from the server if you are certain that it is no longer needed If an export has not been downloaded a pop up window will be displayed to confirm deletion The deletion process can then be cancelled 5 3 Export history Direct method Locin gt Export HISTORY ate 02 04 2013 12 08 CEST a 10 Participant PM Welcome Help Logo seculrial Export Download Export history Export history Proje Description Centre F t nbi Parti t Created or t actio Stat 4l Systemtest 441 6183 CSv xls PM 02 04 2013 12 01 CEST 02 04
9. ample a search could be conducted with the same med ication criteria but the search parameters for gender could be changed 4 3 Copying a search form Direct method Locin gt select a project gt activate the radio button next to the search form gt Copy On the Search form page is an overview of previously created forms To copy a form activate the radio button in the first column and click on the Copy button The name of the copied search form will be automatically incremented and the selected criteria will be adopted You can of course change the name yourself All questions from all of the forms will once again be available enabling you to adapt expand or limit the copied form The name of the form can be changed or adapted The copy of a search form includes the same search criteria as the original without the search parameters refer to Chapter 4 6 As described in Chapter 4 Creating new search forms the criteria in copied forms can be extended or deleted Afterwards save the new form by clicking on the SAVE SEARCH button 4 4 Performing searches Direct method Locin gt select a project gt select a search form Start search smoker_or_non smoker FP Use criteria for search Smoking Habits Light smoker 1 20 cigarettes per day Heavy smoker gt 20 cigarettes per day Passive smoker People who never smoked but are exposed to smoke by people living in the same household or working in the same offic
10. and Comments Audit Trail Form data of hidden fields Print Continue Fig 16 Displayed TAN marker this number is required to download the export 5 2 Downloading an export Direct method Locin gt DowNLoaD Note 09 05 2011 14 34 CEST admin S e C ulr a l Export Download Export history Export download Basisregister Berlin CSv xls 09 05 2011 14 32 26 CEST Export completed 25KB 00 00 37 X Basisregister HGW SAS 23 02 2011 12 18 57 CET Downloaded 25KB 00 00 39 X Basisregister Berlin HGW csv xls 01 02 2011 18 52 00 CET Export completed 21KB 00 00 28 X Fig 17 Part of the download page On this page is a list of all exports that you have personally executed The list includes information about the general export options project centre format the date the export was created on status and duration If the participant has the corresponding rights he can repeat exports by using the arrow pointing to the left see chapter 5 4 Repeating exports All export options will be saved for all exports that have been created from this version of secuTrial onwards including in the export history It is therefore also possible to retrospectively display the options for these exports An information icon i has been created for this purpose in the download list and the export history Click on it and a window will open containing the export options similar to the information displayed in a download
11. be exported as separate columns The column names are created from the identifiers for the form type the repetition the table name and the actual item column name With items from repetition groups identification is carried out via an appendix for the repetition The overall structure of the rectangular export can vary according to the number of repetitions of visits adverse events image forms and sub forms In the export there is an additional table for explaining the visit aspect visit plan of the column names With SAS exports the table names in the column descriptions are replaced by numbers which are also explained in a third table form numbers in the export To assign the related subform content to the main form the internal database ID of the repeti tiongroup question is used For the explanation of the used IDs the question description table question short form qs is always included in the rectangular export format similar to the visit description table With the rectangular table it is not possible to export setup information queries comments SDV or the audit trail Image items also won t be exported in this format A detailed explanation of the rectangular table can be found in the documentation on export formats For decimal numbers and date formats see above the required language can be selected separ ately Selecting the number formats is possible for SAS SPSS and CSV TXT forma
12. cking on the CHANGE PASsswORD button on the Login page For security reasons your password must comply with certain criteria The password must contain a minimum number of characters configurable six to 10 charac ters default 8 and include a non alphabetical character number dot slash etc lt must not be identical to the old password You will be regularly prompted to change your password default every 6 months When choosing your password please be aware of any SOPs that may apply to you If you enter your password incorrectly three times your account will be locked Should this happen please contact your secuTrial administrator who will assign a new password to you Please also observe the applicable regulations and requirements regarding clinical studies and data protection After you have logged in the Welcome page of the secuTrial ExportSearchTool will open g After logging in the welcome page will open This is the starting page for performing exports and for any preliminary searches All of the general navigation buttons are located at the top right of the page see Fig 3 WELCOME HELP LoGouT EXPORT DOWNLOAD EXPORT HISTORY To open or return to the Welcome page To open the Help menu in a new window To exit the ExportSearchTool To open the page for a New export see Chapter 5 5 1 To open the page for Downloading see Chapter 5 2 5 2 To op
13. ct You can select whether the data is to be exported as in the ODM v1 2 specifications or typed according to ODM v1 3 In projects where patient self documentation is used the format CDISC ODM is not available The patient authorship for data is not defined in this standard For projects in which configured randomization is used an additional randomization form in an addi tional RANDOM StudyEvent is created for the randomization The RANDOM form is only composed of one item group in which all randomizations are created as individual items The randomizations are exported with the data export of the AuditTrail in the project version in which the respective randomizations were carried out All randomizations are exported only once as this data cannot be changed once it has been saved Note SAS SPSS With the SAS and SPSS format the export takes the form of import scripts for the data tables in the respective programme syntax To import into the statistics programmer run the reader scripts For SAS the formats from the _fmt sas file must be read first and then the script from the sas file must be run With SPSS run the sps file CSV TXT With CSV format the format can be defined more accurately The reference values answer options for radio buttons or dropdown lists are given as values in medical tables by default However you can optionally specify reference values in extra table so that the DB values are written in
14. d lt ltem completion valida pfs3 mnpfcsO mnpfcs1 mn GroupData gt with Item tion queries com pfcs2 mnpfcs3 mnpfsqa GroupO ID FG FS in all ments SDV DDE mnpfsct mnpfssdv mnpfs lt Form gt or lt FormData gt dde Fig 14 Description of patient and form meta data categories that can be deselected The columns shown in brackets are linked to other project or form settings and will only be exported if the corresponding function has been activated or the necessary information is available You find a further description of the different categories you in the export formats documentation Data handling Checkboxes that have not been selected can be optionally exported as the number 0 or as the value null the display varies according to the format In both cases it cannot be seen whether the checkbox has not been actively selected or whether a value has not been assigned because the form was not saved In a next step it can be selected whether the values for date and time items are to be exported in the existing text format or as a real date or time A default value will be assigned to any elements which are not entered because of the item type or because they were not a mandatory field within the item type The default can be defined for each export If a day later than the 28 of a month is specified in the default date a warning will be displayed when starting the export because
15. e O not C Non smoker C Light C Heavy C Passive Exsmoker applicable smoker smoker smoker O lt Please choose gt y Others or Smoking Habits Light smoker 1 20 cigarettes per day Heavy smoker gt 20 cigarettes per day Passive smoker People who never smoked but are exposed to smoke by people living in the same household or working in the same office Tr not C Non smoker Light C Heawy C Passive Exsmoker applicable smoker smoker smoker E lt Please choose gt z Others Data pool Survey period all visits Form status don t care y Last edit period starts at la A E A 2o 0 Last edit period ends at la E 3 201 1 Centre Haw a Multiple selection with CTRL Zentrum1 lASO Ei Back Search M Store result Fig 6 Example of search parameters entered in a search form containing two Or groups Procedure When performing a search the search form appears with the checkboxes for each item highlighted in pink Activate the corresponding checkbox for each item that is to be defined as a search criterion It is not necessary to use every item in the search form for your search Next determine the parameters which you wish to search for or which parameters must be fulfilled in order to include patients in the group to be exported e g all males all older than 50 Define the data basis in the bottom section of the form enter information on the examination period and the centres see below
16. e start page for a new export with all options previously saved is opened Without the corresponding export rights centres or patients when exporting a search result will be removed from the export selection and a message will appear accordingly You may adjust all options for your current requirements before re starting the export Each repeated export will be logged as a new export in the export history including all options 5 5 Automatic report FTP transfer as an export SQL reports can be transferred automatically from the CustomerAdminTool to an external server This automatic transfer is logged in the database as an export and for each transfer an export entry will be generated and the transferred file will be saved on the server as a copy If a ZIP file contain ing multiple reports is transferred only a single export with all included reports listed will be gener ated The exports are listed in the export history and as the exporting participant only secuTrial will be named Instead of included centres all included reports are listed The reports are only stored by name instead of by database reference For subsequent manual downloads of the report exports there is a new checkbox below the down load list for displaying this type of exports as well By selecting the checkbox all report exports will be listed that belong to projects where the current participant has the right to perform an export To download any of the exp
17. earch from the list using current data in the database click on the name of the search The corresponding search form will appear with all of the previously used search parameters These search parameters can be edited before performing the new search If required the results can be saved by clicking on the Store result checkbox see above Altering or adding search criteria is not possible Simply click on the number of found patients to view the results list and the search criteria It is only possible to view the results of searches which you have conducted yourself Click on the Derete button to delete the search results The search forms used for the searches are not deleted It is only possible to delete search results from searches which you have conducted yourself Please be aware of the difference between search forms on the Search history page and the Start search page see Chapter 4 5 On both pages it is possible to start a new search using previously created search forms However on the Start search page an empty form without parameters is displayed while on the Search history page a search form with all of the search parameters from previous searches is displayed 5 1 Create a new export Direct method Locin gt EXPORT Direct method of exporting with preceding search Locin gt select a project gt select a search form gt start search gt search gt EXPORT Date 09 05 2011 14 17 CEST
18. ed export file The status and duration of the export data that is currently being compiled are displayed in the last two columns on the right To update this information click on the double arrow button at the top right of the screen Only once the compilation process has been completed is it possible to download the export by clicking the name or date The export can be deleted by clicking on the red cross at the end of the row If an error occurs in the database or programme a message may appear stating that the export con tains an error In the case of a database error a new export usually solves the problem If a new export does not rectify the problem a programme error may have occurred In this case please notify iAS To select an export click on the name or date 09 05 2011 14 40 CEST admin D S e C ufr a l Export Download Export history Export enter TAN Please enter the TAN for the export from 09 05 2011 14 32 26 CEST here Submit TAN Back Fig 18 TAN entry field for downloading an export Here you will be asked to enter the TAN for the selected export The export will be downloaded if the correct TAN has been entered followed by the Susmit TAN button If the TAN is incorrectly entered an error message will appear After five incorrect TAN entries you will be automatically logged out Click on the Back button to return to the previous page Once the correct TAN has been submitted a dialogue window will a
19. either select one of the existing search forms a listis presented to you after choosing a project or create a new form Results of searches can be stored and afterwards accessed by the search history You can repeat a search by selecting one of the stored searches in the history For a more detailed description please refer to the help For orientation the current user s data is always displayed in the header on all pages name of the user project if selected and the date The top right area contains all of the general menu buttons including buttons for navigating between the individual functions of the ExportSearchTool Note The results of a search in secuTrial database is always a list with patients It is possible to export all the data for patients or only the list itself All search functions can only be conducted within a project You need to select a project in order to access the search area of the ExportSearchTool 7 In the search area of ExportSearchTool you can create new search forms Use previously created search forms for new searches copy previously created search forms delete search forms you have created initiate and use all of the functions in the header menu e g also a direct export without filtering Please note that the following descriptions refer to two different types of form Search forms are the created pages e g for collecting criteria which serve to reduce
20. en the page Export history see Chapter 5 3 5 3 z The area on the left contains links to the project s to which you have access rights This is where you start the searches and filtering to reduce the number of patients before exporting 3 1 Navigation ate t seculrial cipant Please choose a project for search V Basisregister e HGW e Zentrum1 lASO V Projekte Berlin 2 e HGYV 2 e Zentrum Fig 3 Welcome page 09 05 2011 12 07 CEST admin Welcome Help Logout Export Download Export history Welcome The ExportSearchToo allows you to exchange data with other applications From within this tool you can e export patient data into standarized data formats CDISC ODM SAS SPSS CSV export patient data selectively according centre and visits e start different exports at once let yourself notify via email when an export is finished After the initialization of an export you will get a transaction number TAN which you will need to download the export Please take into account that the system is restarted during night Exports which may not be finished than will not get completed successfully For further advice please refer to the Help On the left side the centres are listed where you can search for patients You can search through one project at a time which you can choose on the left Searches are based on search forms which are combinations of the original project forms You can
21. ending on the selected format the exported data will be saved in one or more files This data is compressed in a zip file for downloading To open the zip file an application such as WinZip or a similar tool is required see Downloading an export Fig 1 Downloadina file IZ Name s_export_C5 xls 70719 zip 30 KB F Type zip Archive From buildserver ias local Open with 62 7 2 ip File Manager v Remember choice and do not show dialog again Dialogue window example for downloading an export To log in to the ExportSearchTool please enter your user ID and password Your user ID will be assigned to you together with your password The login procedure for the database involves three steps 1 Enter your user ID exactly as it was assigned to you Make sure to use exactly the same capital and lower case letters 2 Enter your assigned password 3 Click on the Locin button The first time you log in to secuTrial you will be asked to change your password You can also change your password at any time by clicking on the CHANGE PAasswoRD button on the login page For security reasons your password must comply with the following criteria The password must contain a minimum number of characters configurable six to 10 charac ters default 8 and include a non alphabetical character number dot slash etc lt must not be identical to the old password You will be regularly pr
22. iD I Add ID Vv Investigator and centre information M Project setup M Queries and Comments M audit Trail Double Data Entry O undisplayed duplicates I DDE notfinished yet M Form data of hidden fields Y Send email yes no Your email address D Extended form filter Cancel Start export Fig 11 Start page for a new export from the search results list Searching for and exporting patients who are assigned to multiple centres function patient in mul tiple centres is configured in FormBuilder is always carried out via the home centre i e the centre in which the patient was first created and which is entered in the casenode Format Here you can select an export format Additional format options are available depending on the selected format CDISC ODM v1 3 Format xml SAS format SPSS format CSV format for MS Excel CSV format Text file set field width For the formats SAS SPSS CSV and TXT it is now possible to select the rectangular table as the format form In this format all project data is exported logged in a data table and each patient is exported in exactly one row of data This format is indicated by the prefix rt in the overviews and the Zip file name All forms that are created or displayed in multiple instances either as visit forms in multiple vis its adverse event forms in multiple adverse events follow up examinations or image forms will
23. is displayed The default setting is Status Centre Participant and Visit 5 You can now print the results page export the results list by clicking on the ExceL button patient pseudonyms search criteria data pool The actual data of the matching patients will not be exported Instead a list of the match ing patients as shown on the results page will be exported start a new search or export all of the medical and meta data from the matching patients by clicking on the EXPORT button see Chapter 4 1 Please note that filtering by Status Centre or Participant has no effect on this export 4 6 Search history n Direct method Locin gt select a project gt SEARCH HISTORY Note 2 09 05 2011 14 12 CEST Basisregister seculrial ve 3 New form Forms Search history Export Download Export history History 1 dD uj admin 09 05 2011 13 53 CEST al Delete 2 b smoker or non smoker admin 09 05 2011 13 13 CEST Q Delete 3 b female and smoker and childbearing potential admin 09 05 2011 13 01 CEST 0 Delete lt gt Page 1 of1 Fig 9 Search history page This page displays a list of all saved searches The list includes the name of the search form the participant who performed the search the search date and the number of patients found Use the triangles at the beginning of each line to show or hide the search criteria and parameters To repeat a s
24. isite gt I Ungeplante Visiten Y Y Casenode Y M Casenode lt mnpujbdw1 gt Y M Standardwerte M Gewicht lt gew gt M Gr e lt gr gt MV Date and Time lt dtt gt Text lt tt gt M Date and Time lt dtt1 gt gt I subform Subform lt emnpujwert gt Fig 13 Example of a group of selected items from all form data via the button selected items In addition to the selection of individual items it is possible to deselect individual metadata informa tions These columns will not be included in the export Category Content Column names Tags CDISC SAS SPSS CSV TXT Patient status Deleted frozen de mnpcs0 mnpcs1 mnpcs2 lt Annotation gt 1 2 in lt Sub ceased closed mnpcs3 mnpcs4 mnpcs5 jectData gt Structure Visit plan AE im visitstartdate mnpvisid mn lt Form gt and lt FormData gt ages hidden pcvpid mnpvisno mnpvispat with FormOID F VMI in mnpvisfdt mnpaeid mn lt StudyEvent gt or lt Stu paedate mnpaeno mnpae dyEventData gt for visits fuid mnpaefudt mnpcrtdt mnpcrtpt mnpcrtpusid mn phide Example Document editing Last edit document mnplastedit mnpptnid lt temGroup gt and lt ltem creator form ver mnppusid mnpvsno mn GroupData gt with Item sion pvslibl sigstatus sigreason GroupOID FG MNP in all lt Form gt or lt FormData gt Form status Review freeze mnpfs0 mnpfs1 mnpfs2 mn lt ltemGroup gt an
25. ll be exported Unblinding in exports is listed separately in the export history It is therefore always possible to see which participant requested and carried out the unblinding Filter form content Here it is possible for you to filter the form contents according to status before exporting so not all of the medical data will be exported The default is no check which means that all the forms will be exported The form filter can be hidden or displayed via the triangle icon Completion status if selected only forms with the selected completion status will be exported Data Entry Complete this option is only available in DEC has been configured see DataCap ture manual Only forms with or without completed data entry will be exported Validation this filter refers to settings in the rules of a form These rules can only be bypassed by deactivating the checkbox CHECK bata in the DataCapture tool Forms with the status with warnings if using the rule Confirm input if or rule configuration as confirmation rule or with errors if using the Input required rules will then be saved Review A B only forms which have a review status will be exported Freeze automatic only which have been automatically frozen will be exported Freeze only forms which have been manually frozen will be exported Further information on the different freeze types can be found in the DataCapture manual Comment q
26. lt in very large downloads and for this reason the file size is displayed as additional information on the download page You can choose if the information about the E signature with its validation will be exported Content Column names Tags CDISC SAS SPSS CSV TXT Participant name displayed sig siguser sigtext sigvalid lt SignatureDef gt in lt AdminData gt nature text validity version sigversion lt Signature gt in lt FormData gt Fig 12 With an e signature and validation this information will also be exported It is possible to select individual items questions forms or form families for exporting Only the selected columns will then be created in the tables and exported If no item has been selected from a form in non rectangular formats no file for this form will be created either All items which can be saved from all forms will be listed Sub form items are listed directly within the repetition group Dir ect or indirectly hidden items can only be selected for the export if the option Form data of hidden fields has been previously selected Included data Patient identifier M Pat4D 7 Add D M Centre information M Project setup M Queries and Comments withdrawn queries I Source Data Verification M Audit Trail Double Data Entry l undisplayed duplicates l DDE not finished yet T E signature with validation Y M Form data of hidden fields Form items allitems selected items gt T V
27. me Mozilla Firefox Safari etc We recommend using Mozilla Firefox or Microsoft Internet Explorer from Version 6 0 JavaScript and SSL encryption must be enabled in your browser and MetaRefresh must also be allowed You can disable Java and ActiveX if you wish For security reasons the cache should be set to zero Should you require support with the browser settings please contact your local system administrator To edit exports a programme for opening compressed archive files zip files is required 1 2 General user information The ExportSearchTool is accessed via the internet If your internet connection is slow unsafe or unstable this will inevitably limit the performance of the system The respective URL internet address will be sent to you separately Depending on which browser you are using there may be slight differences in window views or in the menu and print layout All CustomerAdminTool functions have been tested with standard browsers NEVER use the browser functions Refresh Back Forward or Print Please use only the but tons and links within the ExportSearchTool The secuTrial menu buttons are always located at the top right of the page Click on the Wetcome button to return to the ExportSearchTool start page Click on the CanceL button to return to the previous page Click on the CLose button to close the current window and return to the main window Click on the LocourT but
28. no other functions After the search has been completed a page with the search results will be automatically displayed see below g t 09 05 2011 14 07 CEST Basisregister seculrial 4 New form Forms Search history Export Download Export history Result uj 1 of 1 Patients active y lt All gt y lt All gt y cfm791 active Berlin Dipl biol Susanne Schneider 01 01 2010 CET lt gt Page 1 of1 Vv Search criteria Smoking Habits Heavy smoker Data pool Survey period all visits Form status dont care Centre Berlin HGW Zentrum1 lASO Period edittime 09 05 2010 CEST 10 05 2011 CEST p View selection Back New search Print Excel Participant admin Date 09 05 2011 14 07 CEST Project Basisregister Search uj Result 1 Patients Fig 8 Search results with search criteria and parameters At the top of the page the results of the secuTrial database search are displayed with a list of patients who match the search parameters With regard to the completeness of the list please note that only patients to whom you have access rights within your assigned centres will be displayed z The patient list can be filtered by Patient status Centre and Participant The default setting dis plays all active patients The search criteria and parameters are listed further down the page Via View selection in the bottom third of the page you can change the way the list
29. ompted to change your password default every 6 months If you enter your password incorrectly three times your account will be locked Should this hap pen please contact your participant administrator who will assign a new password to you When choosing your password please be aware of any SOPs that may apply to you Please also observe the applicable regulations and requirements regarding clinical studies and data protection After you have logged in the Welcome page of the secuTrial ExportSearchTool will open 2 1 Logout secuTrial web based data capture in clinical trials ExportSearchTool IAS You have successfully logged out To login Fig 2 Information page after logging out n Each time you have finished your work and when leaving your work station you must manually log out Locour in the header to ensure that no unauthorised persons can use your participant account After logging out an information page will be displayed Use the provided link to return to the Login page 7 It may happen that you will be logged out automatically if the server does not register any activity server contact for a longer period of time session timeout The exact time until timeout will be shown in the browser title bar of the main browser window 2 2 Change password The first time you log in to secuTrial you will be asked to change your password You can also change your password at any time by cli
30. ort reports the participant must know the respective TAN configuration per scheme and area in the CustomerAdminTool see above Since large numbers of exports can be created as a result of automatic exports with short intervals or many reports the downloadable exports are now displayed in an overview with 20 exports per page The finished report exports can be deleted by any participant who is able to list them A deletion has no influence on the previous transfer The export will still be listed in the export history If an error occurred when generating the CSV or ZIP file the export will be flagged with an error If the error occurred while transferring the file e g the external server was down the export will be labelled completed but with an additional red exclamation mark flagged as with error In both cases the error message will be shown as a tool tip under status In the latter case the export can still be downloaded manually
31. ow pointing to the left see chapter 5 4 Repeating exports All export options will be saved for all exports that have been created from this version of secuTrial onwards including in the export history It is therefore also possible to retrospectively display the options for these exports An information icon i has been created for this purpose in the download list and the export history Click on it and a window will open containing the export options similar to the information displayed in a downloaded export file If you have the additional role right to delete exports a delete button red cross is displayed next to the export in the export history of the exports for which you have the corresponding role rights The additional deletion right for a centre within the export is sufficient for the right to delete the entire export If an export has not been downloaded a pop up window will be displayed to confirm deletion The deletion process can then be cancelled If you carry out a deletion you will be documented as the last person to edit the export 5 4 Repeating exports All exports that have been created from a current or later secuTrial version onwards can be repea ted Repeatable exports are marked with an arrow pointing to the left at the beginning of the row in the download list or the export history provided the participant has the necessary export rights in at least one centre By clicking on the repeat arrow th
32. ppear in your browser see Fig 19 You can then select where you want to save the export files or directly open the files for editing Note Opening s_export_CSV xls_XP2_20130402 115822 zip You have chosen to open s_export_CS xls_XP2_20130402 115822 zip Downloadina file which is a zip Archive 17 5 kB r Name s_export_CS xls 20148 zip 18 KB from https buildserver ias local m Type zip Archive What should Firefox do with this File From buildserver ias local OY 7 Zip File Manager default Open with En 7 Zip File Manager e O Save File Remember choice and do not show dialog again C Do this automatically For files like this From now on Fig 19 Example of a dialogue window for downloading an export file Firefox and Opera If the dialogue window for saving the export does not open please check in your browser prefer ences whether a standard folder has been set up for saving downloads in which case the export should be there or whether MetaRefresh is not permitted this must be enabled If the problem con tinues please contact your local system administrator or support service Depending on the format the exported archive file zip file contains various sets of files XML CDISC ODM v1 2 1 3 6 files 1 xml with the medical and administrative data and 2 5 xsd describing the format schema SAS sas _fmt sas a dat directory with
33. s adverse event casenode or image forms from the selection list Click on the triangle beside the form family name to display a list of the forms contained within that group Click on the triangle to the left of the form name to view the associated criteria Click on the checkboxes to select the relevant criteria for the search Repeat steps 2 5 until all of the necessary criteria have been selected Save the form using the SAVE SEARCH button and the starting point for performing a search will appear If you do not wish to save the search form click on the Back button When using a search form to perform a search with an or formula this must be taken into account when creating the form see below Example Example And Or criteria groups of criteria And conjunctions suffice when only one criteria needs to be set for each included question when fil tering the data If multiple possibilities need to be taken into account an Or disjunction is neces sary All criteria in a group of criteria can be used as and conjunctions in later searches This means that from the pool of defined criteria in a search form within the individual questions it is possible to select the criteria i e items individually or all of the criteria for later searches and to link them using a logical and conjunction see the examples below Or disjunctions are necessary when the search criteria for a group of criteria sho
34. sadbystitdaadadalvacGaneaadaashagnerboabhaabarananny 16 NN 17 1 A shanna ininenndaneeedennnceees 18 Data bandin csi 20 Randomization and UnbliNding ocoocconnoccccn nnnaccccccnonanannnnc nana n cnn nc canon cnn nn nana ER 20 Filter form CON iii aio lA 21 Mall Notification iii Rd 21 A a a e e aaa a a a O 21 EDISC ODM reae E ET 21 SAS OPO Oana a EE its 22 CSV I TA Dete O A a 22 5 2 Downloading an EXPOlblcoooccccnnnncoccccccconononcnnnonnnnnncnnnnnn nn cnn nr nn nn 22 9 9 EXPO DISON iia ia aid 24 5 4 Repeating exports cccceeceeceeeeeeccncceeeeeeeeeeeeeeeeeeeeeeaaaaaaaeeeeeeeeeeeeeeeeeeeteseeceeeeeeeeesaaeeeeeeeesenaas 25 5 5 Automatic report FTP transfer as an Xxpott cececcceeeeeeececeeeeeeeeeeeeeeeteeceececnaneeaeeeeeeeeeeeeeeaaes 25 This manual provides a step by step guide for using the secuTrial ExportSearchTool Since 4 7 In the current version the following new functions have been introduced Export of Missing Values MV in included data 1 1 System requirements You can access the secuTrial ExportSearchTool using a number of operating systems for example Windows MacOS or Linux No special software needs to be installed on your computer in order to work with the secuTrial ExportSearchTool The software that is required for this tool is installed on a central server To access the software all that is needed is a standard browser Microsoft Internet Explorer Google Chro
35. the amount of data before exporting Forms are the entry masks eCRFs which are used when collecting data in DataCapture This distinction only applies to the text in this manual References to forms in the ExportSearchTool itself apply only to search forms It is not possible in ExportSearchTool to create forms for DataCap ture 4 1 Search Forms Direct method Log in gt Select a project 22 08 2011 18 16 CEST ZID seculrial al New form Forms Search history Export Download Export history Search forms O 1 05 11 2008 14 42 CET Dr Jonas Mustermann Neu C 2 03 03 2009 14 00 CET Ankele ZID SUCHE O 3 26 02 2009 17 34 CET Ankele LAB Copy New qe Page 1 of 1 Fig 4 Search forms page list with previously created search forms After selecting a project on the Welcome page the search area of the ExportSearchTool will be dis played The currently selected project is displayed in the header The first page provides an overview of all of the search forms for this project At the top of the page are also additional buttons to those on the welcome page New FORM To open the page for creating new search forms Forms To open the list of all previously created search forms SEARCH HISTORY To open the list of all previously conducted searches The search forms listed under the menu item Forms can be sorted by Name created at and created by click on the column heading Next to
36. the links to the search forms is a DELETE button for deleting the search forms The results from searches made with these forms will also be deleted Search forms can only be deleted by the user who has created them Forms created by other participants cannot be deleted Note Note The numbering of the individual search forms is intended to provide a better overview and they do not represent criteria for identification purposes they remain after the list changes Editing previously created search forms i e entering search criteria is not directly possible If you wish to use a previously created search form as a template for a new form a copy of the original must be created first see Chapter 4 4 3Copying a search form 4 3 4 2 Creating new search forms Direct method Locin gt Select project gt New or New Form D 09 05 2011 12 22 CEST Basisregister seculrial lt n Teal New form Forms Search history Export Download Export history Create new search form Name Test_nt Search through Visit ha b Demographic gt Smoking Habits b Vital signs Y Vital Signs Use criteria for search TT vital signs Question Fom Family orGroup I Blood pressure gt RB b Contraception and Pregnancy am aaa a a a b In Exclusion Citeria b Lab OR Fig 5 Create a new search form page structure Procedure Give the new search form an easily recognizable and content related name Select a form group visit
37. the med ical tables and the corresponding answers are listed in a separate table After entering all criteria click on the START EXPORT button and the Export started page will open Click on the CanceL button to return to the Welcome page without saving the entries or starting an export On the Export started page the details of the export are displayed once again The application also assigns the export with a transaction number TAN see Fig 16 that is required for downloading the exported data later on The page containing the TAN can be printed out by clicking on the PRINT but ton To proceed directly to the Download page click on the Continue button The page with the selected export options without the TAN is also included in every export as an html file Even if printing is interrupted the data will still be exported You find the details of the exported data formats in the documentation ExportFormats 09 05 2011 14 32 CEST admin y S e C ulr a l Export Download Export history Export started four TA 61187 IMPORTANT Please keep this TAN YOU will need itto download the export file Created on 09 05 2011 14 32 26 CEST Project Basisregister Centre Berlin Visit first visit Patients Valid patients Format CSV format for MS Excel Column names Store reference values same table 150 8859 15 Included data Pat ID Investigator and centre information Project setup Queries
38. this day can result in a shift of month when completing a date In a form item the incomplete date _ 02 2013 has been entered the default date has been specified as 31 05 2013 By adding the day this would result in the 31 February so the whole date will be shift according the calender to 03 03 2013 28 February 3 days The export is performed in the following format secuTrial SAS INFORMAT SPSS CSV TXT Item Typ DD MM YYYY DD MMM YYYY HH MI SS DD MMM YYYY HH MI SS YYYY MM DD HH MI SS HH MI DD MM YYYY DD MMM YYYY DD MMM YYYY YYYY MM DD MM YYYY YYYY HH MI HH MI SS HH MI SS HH MI SS HH MI SS MISS Fig 15 DD double digit day of the month MMM three letters abbreviation for the name of the month MM double digit numerical month YYYY four digit year HH double digit hour with a 24 hour clock MI double digit minutes SS double digit seconds Randomization and Unblinding If you have the role rights for Unblind with export you can also choose whether the randomization is to be unblinded when exporting If unblinding has been selected for an individual export the randomization numbers in the casenode table and in the separate RANDOM form CDISC will be unblinded and the associated group will be exported instead of the number The normal randomization form data remains unaffected by this If blinding is selected the randomization number wi
39. ton to quit the application If you want to log in again you will need to re enter your user ID and password Click on the HeLP button to open the help topics describing the main functions of the ExportSearchTools It is not possible to right click and use the browser s short cut menu on secuTrial pages This is to ensure that navigation only takes place via the provided secuTrial buttons and links If the server does not register any activity for a long period of time your session will automatically time out This guarantees that no unauthorised persons gain access to the database and can change your datasets Activity on the server means saving or changing pages but not just entering data The exact time until timeout is configured on the secuTrial server and is usually 20 minutes The remaining time until the session timeout is displayed in the title bar of the browser window Note 1 3 ExportSearchTool functions The ExportSearchTool enables medical datasets and their metadata to be exported from the cent ral secuTrial database in standardised data formats e g CDISC ODM SAS SPSS CSV for stat istical and biometric analysis The data can be searched filtered and restricted according to pre defined parameters search function Both active and closed projects can be searched and exported This function is not possible any more for inactive projects Searches Two steps are involved when searching for patients 1
40. ts Date formats can only be selected for SAS and SPSS The language format selected for numbers determines whether the decimal point is displayed as a comma German format or by a period English format In exports there are no separat ors for thousands The language format selected for dates determines the three letter abbreviations for the names of the months For this reason the language used for dates can only be selected for formats that use letter abbreviations see fig 15 Included Data Specify here what data is to be included in the export Some options are only displayed and avail able for selection if the project has been configured accordingly for example the Missing Values or the Source Data Verification You can also specify whether a short description of the entire project setup including the visit plan form descriptions Audit Trail centre informations or Queries and Com mentaries is to be exported You can select whether data from hidden fields is also to be exported Only then will queries com ments and SDV be exported from hidden form items as well as visit data if a visit has been hidden For exporting withdrawn queries there is an additional export option Image files can be optionally included in the export as original web display and or thumbnail mini ature files The images will then be placed in an additional patient images folder and integrated in the zip file Including image files can resu
41. uery status only forms with the corresponding comment query status will be exported Source Data Verification only forms with the selected SDV status will be exported E Mail Notification Here you can decide if an e mail notification is sent to you after the export process is finished which may take a while If so please provide your e mail address If your e mail address is already stored in secuTrial the input field may be pre set accordingly Formats CDISC ODM The XML format follows the CDISC ODM v1 3 specifications In secuTrial the following limitations apply Only the roles sponsor investigator and Lab literal name are accepted all other roles are expressed as other Role designations are only possible if a participant is directly assigned to the project The centre designations for participants and patients always refer to the current status and not necessarily to the status at the time of the data entry If the Audit Trail is not to be exported all queries and comments are written as a list of annota tions in the last transaction However this is only possible if the untyped data format has been selected With the selection AS extension in the CDISC format additional elements and attributes are defined which specify the visit plan date query ID e signature validity hidden fields and SDV status if the corresponding function has been configured for the exported proje
42. uld not limit but extend the previous group of questions If Or disjunctions are to be used in the search click on the underlined Or button when creating a search form This calls up a self contained group of criteria which you can later edit to the above schemata see Chapter 4 2 It is possible to use as many Or combinations as you wish in a search form The following examples clarify this Search for all men who have been diagnosed with XY and medication Z For this search the search form must include the criteria gender diagnosis and medication The search only takes into account patients who fulfil these three criteria simultaneously i e within one visit Search for all men diagnosed with XY or medication Z For this search an Or disjunction between two groups of criteria is useful The first criteria group con tains the criteria gender and diagnosis while the second group of criteria contains gender and medication In this case the search takes into account all men diagnosed with XY with or without medication Z and all men taking medication Z with or without diagnosis XY In the above described search forms the search criteria have been set for gender diagosis and medication This means that after saving the form it is not possible to subsequently include addi tional criteria i e age The search parameters men diagnosis XY and medication Z however can be varied as required At a later date for ex
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