Manual data entry in OpenClinica
Contents
1. Begin New Thread j OE Description Detailed Note o Set to Status Not Applicable i 0 Submit Submit amp Exit B 05m fit You can enter a Description and Detailed Note Type will be Annotation by default 232. dy Subject ID 043 01 009 Select the Study Event for which you want to enter data via the select box for example Baseline and click on Proceed to Enter Data Note that by default the Start Date Time will be pre completed by the date of today you do not need to change this date The End Date Time field can be left blank After you have selected proceed to enter data the screen enter or validate Data for CRFs will open See on page 9 and 10 For subjects that are already added in OpenClinica data can be entered from the subject matrix If a subject was added and no event was scheduled after this the status of the event is not started Now the event can be scheduled from the subject matrix To do this you click on the event that you want to schedule and click on schedule see below User Manual data entry in OpenClinica Version 2 28 Feb 2014 Info v Icon Key 15 199 Show More Select An Event A rn 1 tn in i Och Ph oe ar Sr at Sk ene Statuses Not Started F a ti 0043 01 008 a E rs Scheduled ron 043 01 009 is is is Ea i Data Entry Started 043 01 010 i B i3 ia E G Stopped 5 a Skipped Completed A signed Status not scheduled Ea Locked E Schedule Invalid Actions ae After this you can schedule the event as explained on page 8 and click Proceed to enter data 6c How to enter data in CRF If the event is already scheduled the status of t
3. 0 47 Six Min gt Select to Jump i Physical Examination Page ED D Date of physical 05 Jun 20 12 T Ea t Fo examination Height 479 i F cm liii Li The subject s blood pressure should be recorded after he she has rested for a minimum of 5 minutes in the supine position Systolic blood pressure 120 F mmHa supine lt Diastolic blood 80 mmHg pressure supine li lt You now have two options 1 correct the value and then click save again 2 not correct the value and add a discrepancy note see below In order to be able to save the data that are out of range you need to add a discrepancy note by clicking on the blue flag icon behind the weight data field Then the following window opens ProcWeightA Add Discrepancy Note m Google Aanmelden A Qe Procweight a Properties Opties we abe Openclinica Initial Data Entry Subject 01 01 01 Event Baseline ay G Extra v Event Date 25 mei 2012 CRF Event Baseline Form Study Procedures Current Value 80 More pn Y CRF Header Info Add Note There are issue s with your submissi e Weight out of range 35 181 Description Detailed Note Weight out of range 35 181kag Please Physica 5 5 Local L vere Title Physical Examination Page Save Type Failed Validation Check v Date of physical 05 Jun 2014 Set to Status Sassi v examinati
4. a D trait k actmm project Manual data entry in OpenClinica Table of contents Page 1 User Support Information cccccccccccessecceceesecceeceeeeceeeaeeeeessaeeeeessseeeeesaaeeeesaaees 2 2 Getting started in OPENCIiINICa cc ccccecccceccsseeceeceeeeeeeseeeeeeeseeeeeeeseeaeeesseaaeeeessaaaes 2 Za ACCOUN I FOC COIN Suede r eter e gages S ca vanqeanatedenamaenshiaseteasneanenonacs 2 2b User Roles applicable for Site DErSONNEl ccccsecceceeeeeeeeeeeeseeeeeseeeeessasseesaaess 2 2C LOJ INTO OPNO E esaret E E a EE E E E 3 2d Change PASSWOM cccccseececeeeeeceeeeeeceeeeceueeeceesceeseeeeeeseeeeseaseessaseeesaaeeessaeeeesages 3 2e L g O t to OpenClNiC A ers cati ses detednce oss cesses cncleass AE east seadiemacaeeetioeenaaeesSeuacenwactacstes 3 2f COS SANYO Tel MO sses EEES ra 4 3 ODS C II Ca ROME PA e E E 5 4 Required fields in OPN CliniCa ccccccsecccceeeeeceeeeeeseeeeeseeeeeeseeeeesseeeeeseeeeeesaeeeess 5 5 FROWN EO da SUNOS OE ee a r a E E 5 6 PLOW CO SUOMI A eee E E E E E E 7 6a Thestatusota CRF and EVe6 visnsasssncsssrccetccnetendiantauawadanonedsaancsecapeewtatadenmebinnenie 7 6b How to schedule an CVENL ccccccsseececeeeeecsececcaueeeceueeeeseeeesseseeseeeessgeeessaaeeeeas 8 6c How to enter data in GAM peesacosvenvedevianestacacdteantnstnesnsctwshexmnddeebliadysuardnenbabadanneeees 9 6d HOW tO mark CRF COMDIS TS sieruiscasiriroitoi saninin saaa disa o iaia
5. View this Subject s Record axa SaaS Click on the pencil icon to the right of the CRF name to start enter data in this CRF see 1 above This will Open the CRF page see below 11 User Manual data entry in OpenClinica Version 2 28 Feb 2014 Data can now be entered A Date can be entered by clicking on the date picker You can save the data by clicking on Save see 1 below Navigate to the next section in the CRF via the tabs see 2 below or via Select to jump see 3 below Always click Save before you go to the next section unless you do not want to save the data Event Baseline Form General v1 4 043 01 010 Y CRF Header Info gt Select to Jump v Subject Demographics Inclusion Criteria Exclusion Criteria Cardiac Disease Classific tio iovascular Medical Histe Page Date subject signed informed consent 04 Mar 2012 Date of baselir i 02 Mar 2012 Ey yo assessmen 6d How to mark CRF complete If you think data are completely and correctly entered you may click on Mark CRF Complete You can do this in the last section of the CRF see below Event Baseline Form General v1 4 043 01 010 vy CRF Header Info Cardiac 1 1 Title Currg cardiovascular medmmgtions Page C Mark CRF Complete Is the suby WwW any cardiovascular 7 n 3 riri e eli otteet Yes please list each medication
6. generic name Click SAVE to get a list Medications boxx Yyyyyy w Add CI Mark crF Complete TS CT If you mark the CRF Complete the status of the CRF will change to Completed see below After entering and saving the data for this CRF the overview of CRFs that belong to this event will be shown again also see below The other CRF page s can be completed in the same way as the previously explained 12 User Manual data entry in OpenClinica Version 2 28 Feb 2014 Alerts amp Messages Y Instructions v Enter or Validate Data for CRFs in Baseline Info y f E Study Events Edit Study Event Study Events 1 Study Subject ID 043 01 011 Baseline Study Event Baseline Status data entry Location N A aa started s Study Subject OID SS_04301011 g Event Baseline Form Start Date 30 Mar 2012 fo General v1 4 P 3 End Date Time fe B event 7 Subject Event Status data entry started Baseline Form Study Procedures Last Updated by MCavelaar 30 Mar 2012 CRFs in this Study Event CRF Name Version Status Initial Data Double Data Actions Entry Entry Event Baseline Form Study v1 0 2 e Procedures za AS 5 Event Baseline Form v1 4 MCavelaar n a General ra r From the enter or validate data for CRFs window you can click on the View this Subject s Record see above to get an overview of status of data entry for the events that are scheduled
7. is is within AN dawe The site entering data i e the Clinical Research coordinator and the Investigator should respond to the red and the yellow flags New and Updated Also note the guideline regarding responses to these types of Discrepancy Notes page 18 In the overview you can filter on the status of the discrepancy see below Here you can select the option New and Updated for Resolution Status oo Show wore EB Study subiect 0 Tv9e Resolution stats ste 10 Day open Days Since updatea event name cnf Enty name entity van 043 01 013 Failed New 0 Baseline Event BaseSubCRT 1 Validation Updated Baseline Check Resolution Proposed Form lt General New and Updated By clicking on the magnifier icon in the column Actions you can directly open the discrepancy note and propose a resolution By clicking on the icon you navigate to the CRF that contains the data field with the Discrepancy Note concerned There you can click on the flag icon to open the discrepancy note and propose a resolution By clicking on the icon the CRF will only open in view mode Therefore it is not possible to change the entered data in the CRF For this you need to go to the CRF via the Subject Matrix A Discrepancy can be assigned to you This is visible in the column Assigned User 16 User Manual data entry in OpenClinica Version 2 28 Feb 2014 7a Example of an Annotation At any time you can add a comment to d
8. 10 6e How to change data that are previously Entered cccccsseeceseeeeseeeeeseeeneeeeeaeees 12 6f How to set the status of an event including sign the CRF cccccseceeseeeeeeees 12 7 Notes amp DISCrEDAN Cle c ccccsecccceececeeeeceueecceseeceusecsueeseeeeessueesseeeenseeessusenseneenees 13 7a Example OF Gh ANMOLAN OM econscsssicoriansssecetstmoiitmoaiaelmactannanyenecasaaesubeqenisimeiavouincaact 15 7b Example of a Failed Validation Che ck ccccccccccccsseeeseeeeeeseeeeseeeeseeeeesseneeessees 16 7C SECLE LETE TY agrees as ene E E E E E N 18 7d Example of Reason for Change cccccccsseececesseeeeeeeeeeeeeeeeeeeeeesaeseeseeeesseseeesaaeees 20 7e More than one discrepancy for a data field ccccccceseeeeeseeeeceeeeseeeeeseeeesseeeeaaees 20 User Manual data entry in OpenClinica Version 2 28 Feb 2014 1 User Support Information A study in OpenClinica is coordinated centrally by a study coordinator or study manager Please contact your study management study coordinator if you have any questions about the study or about working in OpenClinica e g entering data monitoring data signing completed CRFs If necessary the study management study coordinator will contact the OpenClinica administrator How to protect subject s privacy Do not enter any identifying information about study subjects in OpenClinica The following type of information is considered identifyi
9. which is indicated by the color of the flag New Updated Resolution Proposed Closed or Not Applicable The status indicates if an action is required and by whom The status Closed and Not Applicable do not require any action The status Resolution Proposed require an action by the monitor study team The status New and Updated require an action by the site entering data i e clinical research coordinator and investigator You can get a list of all Discrepancies by clicking Notes amp Discrepancies in the top of your screen In the screen that opens all Discrepancies are listed and a summary of this list is given in the top of the screen see below 15 User Manual data entry in OpenClinica Version 2 28 Feb 2014 Home Subject Matrix Add Subject Notes amp Discrepancies Trsks Report issve Support SITET Im cs Notes and Discrepancies Query Failed Validation Check Reason for Change Annotation Total New fe i 3 4 Updated fo Resolution Proposed fo 2 2 Closed fe 4 4 Not Applicable yo 1 1 Total 1 5 1 11 QSAR show More B S 043 01 009 Query New UMCU 0 0 Baseline Event BaseSubject 1955 please Marinel G E Baseline verify Cavelaar Form MCavelaar General 0043 01 008 Failed New UMCU 9 9 Baseline Event BaseDateofMy 23 Mar 2012 R32 Date gy emp Validation Baseline of most Check Form recent General Myocardial Infarction
10. 20 ae supine Diastolic blood gq mmHg pressure supine Then click submit and the flag will turn to green Y CRF Header Info There are issue s with your submission The data has NOT been saved See below for details Weight out of range 35 181kq Please verify Physica_ 5 5 Localt 0 47 socmin 0 i2 _ gt Title Physical Examination Date of physical 05 Jun 2012 fo examination 1 Height 172 Wom ji E The subject s blood pressure should be recorded after he she has rested for a minimum of 5 minutes in the supine position Systolic blood pressure 120 F mmHg supine Diastolic blood 80 Pe mmHg pressure supine lt Now you can save the data in this section of the CRF NB sometimes the flag will only turn to green after you clicked the save button 19 User Manual data entry in OpenClinica Version 2 28 Feb 2014 The monitor study team can respond to this discrepancy note If they do so the color of the flag will turn yellow which means the note has been Updated see below EES at BA Hide summary statistics Query Failed Validation Check Reason for Change Annotation Total New u Updated i 1 fu Resolution Proposed Pi Closed Fi Not Applicable Hi Total 1 1 15 show More EB a ty Subject Type Resolution Status Site T Days Opn Day Since Updated Event Name CRF Entty Name tty Value Desertio
11. Guideline for response to Discrepancy Notes with status New Updated on page 18 Do not forget to save the form once more afterwards The monitor study team will close the discrepancy note if the resolution is acceptable 21 User Manual data entry in OpenClinica Version 2 28 Feb 2014 7d Example of Reason for Change If the CRF is marked as completed the system will ask you to give a reason for change in case you change the data Event Baseline Form General v1 4 T RF Header Info There are issue s with your submission The data has NOT been saved See below for details Adminis 3 3 Subjeet 2 2 Inel si 77 m Select to Jump b d Title Administrative Information Page Date subject signed L 02 Mar 2012 H informed consent Date of baseline 01 Mar 2012 assessment i a Pc E CEF CUA i You can follow the same procedure as in case of a Annotation Click on the flag icon and provide a reason for change Click Submit amp Close and now you are able to save the data on the CRF The color of the flag will change from blue to white which means not applicable 7e More than one discrepancy note for a data field One data field only has one flag icon However more discrepancies may be added For example a validation check may have failed and at a later stage a reason for change may be required In case you need to add an Annotation to this data field a new thr
12. Now the following overview opens View Subject 043 01 010 i Study Subject Record E Events Page 1 of 1 GED Schedule New Event Event Occurrence Start Date Location Status Actions CRFs Name Version Status Updated Actions Number Baseline 30 Mar 2012 data Event Baseline Form v1 4 30 Mar 2012 entry General MCavelaar started Event Baseline Form v1 0 30 Mar 2012 Study Procedures MCavelaar Implant 30 Mar 2012 data Event Implant Form vi 2 entry Implant started Prehospital Discharge 30 Mar 2012 data Event Prehospital Discharge v1 2 entry Form Prehospital Discharge started 1 Month Follow up 30 Mar 2012 data Event 1 Month Folow up v1 7 a entry Form 1 Month Follow up started Adverse Event 1 30 Mar 2012 data Event Adverse event v1 1 entry Form Serious Adverse started Event SAE Event Adverse event 2 fz Ga amp Form Serious Adverse Event SAE Update Event Adverse event v2 i 2 E Form Serious Adverse Event SAE Update2 R E E REEN Cinan A f ia Fm 13 User Manual data entry in OpenClinica Version 2 28 Feb 2014 6e How to change data that are previously entered The procedure to change data is the same as entering data explained on page 9 10 Click on menu option Subject Matrix and click on the event for which you want to change data and then click View Enter Data 6f How to set the status of an event including sign the CRF To manually set th
13. OpenClinica Version 2 28 Feb 2014 2c Log in to OpenClinica Open the internet browser OpenClinica kan benaderd worden via Internet Explorer versie 7 of hoger en Firefox versie 3 of hoger OpenClinica is niet compatible met Chrome en Safari Goto the following address www openclinica n Enter the user name and password as received by e mail and click on Login OpenClinica Login News User Name Ipiipers Password 2d Change password The first time you login to OpenClinica you will be asked to change your password A password of 8 characters is required Reset password eo fee Pa on co 7 Welcome to OpenCinica Cecilia Svenssor indicates required field Old Password New Password Confirm New Password Change Password Xt 2e Log out to OpenClinica When you are finished with data entry you must log out This prevents unauthorized persons from viewing or changing data You log out by clicking on the link Log Out in the upper right corner of the screen User Manual data entry in OpenClinica Version 2 28 Feb 2014 User Manual data entry in OpenClinica Version 2 28 Feb 2014 2f Glossary of terms Below the OpenClinica terms are explained that are used in this manual Study In OpenClinica a clinical trial or clinical research project including all the metadata and data for it Sites Locations where the Study is taking place You can work with O
14. Subject Matrix Not Started If no date has been given for an Event Scheduled If a start date is given but no data entry has been performed yet Data Entry Started If data entry has started on one of the CRFs of the Event Completed When all required CRFs of an Event are Marked as Complete Skipped Sometimes a visit is skipped In that case you can manually set the status to Skipped Stopped Under very rare circumstances data entry of an Event will be stopped halfway In that case you can manually set the status to Stopped Signed If the investigator has signed the event CRFs can be checked using the source documents the so called Source Data Verification or SDV This is done by the Study team and it will not be visible to you by a change in icons 8 User Manual data entry in OpenClinica Version 2 28 Feb 2014 6b How to schedule an event Before data can be entered for an event the event needs to be scheduled in OpenClinica This means that a Start Date Time needs to be given This is a system requirement and there is no meaning to this date for the user Therefore the default date date of today can be used An End Date Time is optional and should be left blank After you have added a subject in OpenClinica you can proceed to schedule an event enter data by clicking Save and Assign Study Event see below Now the next screen will open Schedule Study Event for 043 01 009
15. ata you have entered by clicking on the blue flag icon next to the field For example you want to add a comment to weight click on the flag icon right to the item weight see below Weight Enter your information about the weight see below The type will be default set to Annotation When you click submit the flag icon will turn to white meaning not applicable ProcWeightA Add Discrepancy Note ProcWeightA Properties Subject 045 01 005 Event Baseline Event Date 25 Apr 2012 CRF Event Baseline Form Study Procedures v1 2 Current Value More Data Dictionary Add Note Description measured with clothes and shoes Detailed Note Subject was wearing clothes and shoes during measurement Type Set to Status Not Applicable 17 User Manual data entry in OpenClinica Version 2 28 Feb 2014 7b Example of a Failed Validation Check Depending on the setup of the study automated validation checks may be executed on the entered data An example of a failed validation check is shown below if entered value for weight is too high and you click save the message Weight out of range Please verify is shown The data has not been saved so far since the system wants you to check the entered data first vy CRF Header Info There are issue s with your submission The data has NOT been saved See below for details e Weight out of range 35 181kq Please verify Physica 0 5 Local L
16. both options Tange Sway Site rmLaveliaar Unica Kesearcn Voorainator en MARKU CHMICa STUGY UNIVErTSsIL ppaki BETU ULU earcn Voorainator og amp OpenClinica Home Subject Matrix Add Subject N tes amp Discrepancies Tasks v Report Issue Support Go Submit Data Alerts amp Messages i z TOR n Subject Ma Schedule Event Subject Matrix for Universitair Medisc oe Instructions G Add Subject View Events Info z otes amp D pancies Import Data ge m An Eu Other Icon Key 15 Show More Select An Event wi ae a pdate Profile og Ou Sty Sabect 1 Basen Implant Prehontal Dacharge 3M 3 Statuses Apply Filte e tatstartes 0043 01 008 a Scheduled Results 1 1 of 1 Data Entry a Started EA ori After clicking Add Subject the next window will appear test Add Subject indicates required field Study Subject ID Person ID lt Secondary ID Date of Enrollment for Study Fat free mass 24 Jul 2012 and cachexia during chemotherapy Sex Select w Date of Birth Depending on the setup of the study some of the fields may not appear or may not be required to fill out fields that are not marked with an asterisk can be left blank The Study Subject ID is always a required field The study management study coordinator will give you an instruction which Study Subject IDs and Person IDs if required should be used and which date needs to be chosen fo
17. e status of an Event you first schedule it if you haven t already done so In the Subject Matrix you click on the Event and in the floating window you click View Enter Data In the screen Enter or Validate Data for CRFs in Event name you click Edit Study Event or the pencil icon in the upper right corner see below Alerts amp Messages Enter or Validate Data for CRFs in Baseline Instructions Info v a Study Events Study Events 3 Study Subject ID 043 01 012 3 Baseline Study Event Baseline Status Location Wo a Event SEE Baseline Form Study Subject OID _04301012 General v1 4 l Start Date 05 apr 2012 fo a Farg End Date Time fe Study Procedures Subject Event Status signed v1 1 i Last Updated by MCavelaar 1 15 apr 2012 Implant lonth Follow up CRFs in this Study Even CRF Name Version Status Initial Data Double Data Actions Entry Entry Event Baseline Form 1 4 lierse n a 2 E9 Event Baseline Form Study v1 1 MCavelaar1 n a Ea SR E Procedures In the window that opens you can set the status of the Event to Skipped or Stopped The CRF can only be signed off by the investigator To do this the investigator should manually set the status of the Event to signed see below This is only possible if all CRFs for this event are marked complete Update Study Event After submit changes is clicked the following window opens 14 User Manual data entry in OpenC
18. ead needs to be opened If you click on the flag icon the following screen will open 22 User Manual data entry in OpenClinica Version 2 28 Feb 2014 BaseSubject Notes and Discrepancies BaseSubject Properties Subject 043 01 009 Event Baseline Event Date 01 Apr 2012 CRF Event Baseline Form General Current Value 1955 More Data Dictionary Audit History Note Details E new information Last updated 01 Apr 2012 by MCavelaar Assigned to J ID 48 Type Reason for Current Status Not of Notes 1 Change Applicable new information Status Not Applicable 01 Apr 2012 by MCavelaar O please verify Last updated 01 Apr 2012 by MCavelaar2 Assigned to Marinel Cavelaar MCavelaar please verity Status New 01 Apr 2012 by MCavelaar Assigned to Marinel Cavelaar MCavelaar the source document shows another year of birth Update Note Propose Resolution Close Note Begin New Thread C Audit History Audit Event Date Time of Server User Value Type Old New Item data value updated 01 Apr 2012 09 17 26 MCavelaar Base Subject 1955 This item was initially entered on 01 Apr 2012 Click on Begin New Thread to add an Annotation The next window will open BSS Ww Mane Lave Lave Type Query Current Status Mew of Notes 1 please verify Status New 01 Apr 2012 by MCavelaar2 Assigned to Marinel Cavelaar MCavelaar the source document shows another year of birth
19. he event is scheduled 1 You can enter data for events by clicking on the event or 3 and then click on View Enter Data see below in the floating window Info v Icon Key as q si i More Select An Event re TOON yn 1 tinier ces Menin tow Ars mn SD St re 0043 01 008 a E Sheed 043 01 009 os o 5 i E Data Entry oia Sie Gs Started 043 01 010 3 E E Stopped 043 01 0 omz 5 Sh fi j 043 01 011 X Skipped 043 01 012 R Baseline E Completed Results 1 5 of 5 signed 5 Locked Invalid Now the screen enter or validate Data for CRFs will open see below In this screen all CRF pages are listed that should be completed for the Baseline visit 10 User Manual data entry in OpenClinica Version 2 28 Feb 2014 Alerts amp Messages v s L Enter or Validate Data for CRFs in Baseline Instructions v Info 7 al i Edit Study Event Study Events i sf Fa Study Events 1 Study Subject ID 043 01 015 Baseline Study Event Baseline Status scheduled Location N A fo 5 Event Baseline Form Study Subject OID SS_04301015 General Start Date 26 apr 2012 Yu a Event Baseline Form End Date Time 26 apr 2012 fo Study Subject Event Status scheduled Procedures Last Updated by 0 CRFs in this Study Event CRF Name Version Status Initial Data Entry Event Baseline Form General E Event Baseline Form Study v1 2 M 2 za 3 8B j za i Procedures
20. hows the status of data entry for the events in the row to the right of the Study Subject ID This page also shows the Notes amp Discrepancies that are assigned to you This also will be explained in more detail later OpenClinica Home Subject Matrix Notes amp Discrepancies Study AuditLog Tasks v Report Issue Support Go Alerts amp Messages n Subject Matrix for Testi Instructions Info Icon Key a 15 v Show More Select An Event Add New Subject Study Subject 10 tro to next ABP administration 3 4 ws End of Study l Statuses Not Started 0001 Scheduled 0002 Data Entry a Started ai Stopped 0004 im Skipped Completed 0006 J B a B or Results 1 7 of 7 ima 4 Required fields in OpenClinica All fields that are indicated with an asterisk in OpenClinica are required fields and need to be completed 5 How to add a subject Below a general explanation is given for data entry in OpenClinica If you want to enter data for a new subject you need to Add the new subject explained on the next page Schedule the event for which you want to enter data explained on page 8 6b Open the CRF page for which you want to enter data explained on page 9 6c User Manual data entry in OpenClinica Version 2 28 Feb 2014 To add a new subject in OpenClinica click on menu option Add Subject or click on menu option Tasks and then Add Subject see below for
21. linica Version 2 28 Feb 2014 Update Study Event Enter your user name and password below to signify agreement with the following statement As the investigator or designated member of the investigator s staff I confirm that the electronic case report forms for this subject are a full accurate and complete record of the observations recorded I intend for this electronic signature to be the legally binding equivalent of my written signature User Full Name Marinel Cavelaar Date Time The exact date and time will be recorded by the system upon submission of the signature form Role Investigator Here the investigator should enter his her user name and password and then click on Submit Now the status of the event will change to signed 7 Notes amp Discrepancies The OpenClinica Notes and Discrepancies module provides a means for users to document communicate and manage issues about data in the clinical study There are four different types of notes discrepancies in OpenClinica 1 Annotation this is a comment to data that is given by the person who entered the data 2 Failed Validation Check this is an automatic query by the system that fires when a validation check fails 3 Query This is a manual query that is put in to the system by the study team 4 Reason for Change if the CRF is marked as completed the system will ask you to give a reason for change of the data A Discrepancy has a status
22. n 2 28 Feb 2014 BaseSubject Notes and Discrepancies BaseSubject Properties Subject 043 01 009 Event Baseline Event Date 01 Apr 2012 CRF Event Baseline Form General Current Value 1955 More Data Dichonary DUOC Pisco Note Details please verify Last updated 01 Apr 2012 by MCavelaar2 Assigned to Marinel Cavelaar MCavelaar ID 44 Type Query Current Status New of Notes 1 please verify Status New 01 Apr 2017 by MCavelaar2 Assigned to Marinel Cavelaar MCavelaar the source document shows another year of birth Begin New Thread Audit History Audit Event Date Time of Server User Value Type Old New Item data value updated 01 Apr 2012 09 17 26 MCavelaar BaseSubject 1955 In case that you want to edit the original data you need to go to the CRF via the Subject Matrix as also explained on page 9 10 For more information you can first click on the View within record icon The CRF will now open in view mode and you can navigate to the right section to find the appropriate field Adminis 3 3 Subject 2 2 Inclusi 7 7 e select to Jump Tithe Subject Demographics Subject year of birth 1955 Fe Gender Mae W Female Retun to top a TD Change the data appropriately and afterwards click on the red flag to open the discrepancy for proposing a resolution same as for Failed Validation Check also see the
23. n As 01 01 01 Updated 01 01 01 Failed Y Updated UMCU 37 o Baseline Ewent FrocWeightA 600 is the true Mar Validation Baseline value Cay Check Form Mc Study Procedures Results 1 1 of 1 d You have to respond to this updated discrepancy note again For example after you have measured the weight again you open the discrepancy note and click Propose Resolution again Add a description and detailed note and then click on Submit amp Exit The flag icon will turn to green again meaning resolution proposed If the study team is satisfied with the resolution they will close the discrepancy note The flag will turn black if a discrepancy note is closed Guideline regarding response to Discrepancy Notes with status New Updated If you change a value based on a discrepancy note with status New red flag or Updated yellow flag or if you add a Discrepancy Note because of a Failed Validation Check then set the status of this note to Resolution Proposed In this way it is clear that there is no action expected from you as clinical research coordinator 7c Example of a Query If the monitor study team has questions about data they can add a discrepancy note of type Query This you will find again as a new discrepancy note in the list of discrepancies Open the discrepancy note by clicking on the magnifier icon at the end of the line to see the details of the query 20 User Manual data entry in OpenClinica Versio
24. n adding a Subject to a Study Secondary ID An optional identifier given to a Subject Not to be used to register identifying information about the subject Remove A remove action makes the information unavailable in the OpenClinica system You can restore information that has been removed to make it available again Most information in OpenClinica can only be removed and not deleted so that it can be restored if necessary However in some cases information can be deleted See also the glossary description for Delete Delete A delete action completely removes the information from the OpenClinica system Deleted information cannot be restored although the audit log tracks the deletion action User Manual data entry in OpenClinica Version 2 28 Feb 2014 Nearly all information in OpenClinica can be removed rather than deleted because removed information can be restored Discrepancy Notes Means of communicating about CRF Items whose value condition level of detail etc are not as expected Audit Log System feature that maintains a historical record of key actions related to a Study Subject that have run on the OpenClinica database 3 OpenClinica Home Page After logging in the home page will appear This home page is the same for Investigators and Clinical Research Coordinators This page shows the Subject Matrix which gives an overview of all subjects in the study that are entered in OpenClinica in your center first column and s
25. ng and should not be entered in OpenClinica Subject s name initials ZIS hospital number BSN NB date of birth is not allowed for studies that started after February 2014 unless measures are taken that are required by law Wet bescherming persoonsgegevens Also mind that you do not enter identifying information in free text fields such as fields to enter comments 2 Getting started in OpenClinica 2a Account Procedure If you want to enter data in the eCRF for a study you need to have a user account in OpenClinica OpenClinica Account Procedure 1 Please send a request for user account to the study management study coordinator a Fill in your hospital name your role in the study name and e mail address b Indicate the requested user role at site level 2 Study management study coordinator will send the account request to the OpenClinica administrator via TralT Topdesk 3 The account information will be sent to you by e mail sender is servicedesk ctmm trait nl 2b User Roles applicable for site personnel There are four study roles at site level It is recommended to let your OpenClinica study role correspond to the tasks delegated by the Principal Investigator on the Delegated Task List Possible User Roles at Site level a Investigator data entry amp signature b Monitor verification of entered data c Clinical Research Coordinator data entry d Data Entry Person data entry User Manual data entry in
26. on a m Height 172 O Submit Weight 1 Bo D00 The subject s blood pressure should 7 Gereed Internet 100 Systolic blood pressure 120 i supine Diastolic blood 30 7 Fa mmHg 2 M ie pressure supine 18 User Manual data entry in OpenClinica Version 2 28 Feb 2014 Enter a note in the field for example is the true value see below By default the type of the discrepancy note is Failed Validation Check You should set the status of the note to resolution proposed see below Bewerken Beeld Favoreten Ext ProcWeightA Add Discrepancy Note as Aanmelden 4 7 Google nF Procweight a Properties Opties z p gt w abe Openclinica Initial Data Entry Subject 01 01 01 Event Baseline ay g Extra v Event Date 25 mei 2012 CRF Event Baseline Form Study Procedures Current Value 80 More Data Dictionar v CRF Header Info Add Note There are issue s with your submissi Weight out of range 35 181k Description is the true value Detailed Note Weight out of range 35 181kg Please Physica 5 5 Local L 0 47 verify Title Physical Examination Page Save Type Failed Validation Check v Date of physical 05 Jun 2014 Set to Status examination Height Weight I 600 The subject s blood pressure should till Gereed Internet Qio Systolic blood pressure 1
27. penClinica at the Site level which limits the view of the Study to a specified Site Study Level A view of the Study that aggregates information and data for all Sites in the Study User Person using the OpenClinica software A user can have one or more Roles in one or more Studies or Sites Roles Categories for users in OpenClinica that determine the tasks available to them in the system Event See Study Event Study Event A visit or encounter in the Study where data is captured or created A Study Event packages one or more case report forms CRFs CRF Case Report Form A form that collects Study related information for a Study Subject CRFs are composed of Sections Item Groups multiplied via Add button in CRF and ltems CRFs can have multiple versions Subject Case Book All CRFs for all Events for a Study Subject Subject Matrix Overview of all subjects in the Study that are entered in OpenClinica in your center with the status of data entry Item Also known as a data Item A single question in a CRF Items have metadata attached to them Each Item has an Object Identifier OID attached to it Items can have multiple Edit Checks attached to them Enrollment Adding a Subject to a Study The OpenClinica Enrollment Date is when the Subject is added to an OpenClinica Study Study Subject A person added to a Study in OpenClinica Also referred to as a Subject Study Subject ID A unique identifier generated manually whe
28. r Date of Enrollment Now you can click on one of the four options lf you do not want to proceed to schedule an event enter data you can Click Save and Finish Then you can proceed to enter data for that subject at a later time You can add another subject by clicking on Save and Add Next Subject When you click on Save and Assign Study Event you will schedule the event see 6b How to schedule an event User Manual data entry in OpenClinica Version 2 28 Feb 2014 6 How to submit data 6a The status of a CRF and of an Event An event can have different statuses These are indicated by icons and these icons are used for Events and for CRFs Statuses Not Started event CRF Scheduled event Data Entry Started event CRF ie Stopped event set manually eh Skipped event set manually e Completed event CRF A signed event set manually Locked CRF EX Invalid CRF Status of a CRF The status of a CRF can be Not Started nothing has happened yet Data Entry Started once you have opened the CRF but not necessarily entered data Completed when you have marked CRF complete Locked if a version of a CRF is archived then the status of the CRFs that were already opened will change to Locked and Invalid all CRFs for a subject that is removed Status of an Event The status of an Event changes in a similar way as status of a CRF but it has more statuses You can see these in the
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