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1. ccccccccceseeececceeeeececccaaeeceeesaaueeceeesuaueeeeeseeaaeeeessaaeeeeeseeaueeeeeeeessageseesssageeeees 7 4 2 Solving discrepancies cccccceccaeeeeseceeeeecaaeeeeeceeeceaeeeeeeeeeeesesaeseceeeeesseeeasseeeeeeeesseeaseeeeeeeeesssusaeeeeeeesaaas 7 S Palen earen pinnene AEEA AEAEE E i EAEE iaie nenia 8 CAU T eenn E E EEE EE E 10 TYE e E E E E E N 10 BV SMMC ATOM eessen E Ee iE aani iai ERNAS EEEE EAEE 11 9 Approval 0 iO te 13 APPENDIX 1 Study visit overviews PRAETORIAN ccccsssssseeeeceeeeeeeeeeeeeeeaaeeeesseesceeeeeeeesesesesaaaaaeaeeeeeees 15 User Manual eCRF PRAETORIAN study gt Clinical Research Unit V2 05nov2012 Academic Medical Center University of Amsterdam Page 1 of 16 Nordkamp at T 0031 0 20 56 67731 L R OldeNordkamp amc uva ni For technical problems please contact Alden van Putten at T 0031 0 20 56 61911 at E cru oc amc uva nl If you have any questions regarding the study please contact Louise Olde a m Clinical Research Unit 1 Abbreviations and definitions 1 1 Abbreviations CRA Clinical Research Associate CRF Case Report form CRU Clinical Research Unit eCRF Electronic CRF OC Oracle Clinical RDC Remote Data Capture 1 2 Definitions CRA Monitor CRF In OC RDC a single eCRF page is meant Discrepancy also known as a query Data related error or inconsistency which needs to be resolved OC RDC Oracle Clinical Remote Data Capture or just Oracle Clinical
2. Nordkamp at T 0031 0 20 56 67731 L R OldeNordkamp amc uva ni d m For technical problems please contact Alden van Putten at T 0031 0 20 56 61911 at E cru oc amc uva nl Clinical Research Unit Figure 14 Approval of CRF pages eya eal EE LEG Choose Approve Logout Change Password Help Home Casebooks Review eports from this menu CRFs Discrepancies Investigator Comments ogged in as Jolanda Strubel Site user PILOT1 Last Refresh 25 Aug 2011 11 25 Patient CRFs Study RELICO Site 138201 Patients Selected 3 Patient Range x1 Q x3 j Q Assigned Book Any Acrepancy el _ iS val Not Approved z Execute CRF Name AIl v An search o Refresh CRF Status Entry All vf e CRF Source Casebook All Visit All Patient CRFs Fi Show Timestamps Patient Visit Date Open Select Number Name Date CRF Name Casebook Modified Verified Approved Locked CRF CO X1 V1 11 feb 2001 DEMO RELICO E oO x1 V1 11 feb 2001 VITALS RELICO X1 V2 12 okt 2001 SKIN RELICO x1 v2 12 okt 2001 VITALS RELICO O X1 V3 13 okt 2001 SKIN RELICO Ej e The Approve dialogue window appears e Enter your username and password and click the Continue button e To approve the pages click the Yes button and then the Close button e The approved pages are now displayed with a signature to indicate that they are approved
3. All CRF Status Entry An v Discrepancy All Approval All CRF Source Casebook an x Visit E x CRF Name Au Patients Previous ff RELICO visit vi w Add Visit Page Add Other Page Refresh Patient vi Select Number Demo Vitals Vitals 1 an B He ae Eo pe X3 2 O E 2 E u1 O 7 ws nb 1 nb 2 8 Verification In OC it is possible for the monitor to indicate in the system which pages were verified against the source documents You can indicate a single CRF page as verified e Open the CRF page and verify the entered data against the source documents e Choose the verification tool from the toolbar see figure 15 Figure 15 Verify tool in open CRF page ORACLE RDC Onsite Data Entry Preferences Help Study Site 140204 Patient X1 Casebook INTERMIT Qacra Qacra CRA role EE Previous CRF Next CRF Highlight Active and Other Discrepancies i Fal E Ef 7 x gt Doc Visit Name DCI Date Study Name Visit fo DCI Time Subevent Status Site DCI ShortName i Investigator DCI Name Is Blank a 4 Comment Patient ill TCT _F qy nz ALGEMEEN Centrum nummer ap Nate nf Rith lar ann ence Tamnaratura Fa 4 w lt Copyright 2000 2007 Oracle All rights reserved e After closing the page and refreshing the overview the CRF icon will now include a tickbox to indicate the page was verified see figu
4. CRFs that have undergone changes since approval need to be re approved see also the CRF icon in figure 7 e Schedule your last approval session after Source data verification has been performed by a monitor and after reviewing and resolving all open discrepancies User Manual eCRF PRAETORIAN study Clinical Research Unit V2 05nov2012 Academic Medical Center University of Amsterdam Page 14 of 16 If you have any questions regarding the study please contact Louise Olde Nordkamp at T 0031 0 20 56 67731 L R OldeNordkamp amc uva ni For technical problems please contact Alden van Putten at T 0031 0 20 56 61911 at E cru oc amc uva nl Clinical Research Unit APPENDIX 1 Study visit overviews PRAETORIAN There are 2 types of eCRFs named S ICD and TV ICD 1 1 Overview of visits and associated CRF s S ICD VISIT BASELINE So i SF36 DASI _QUES S_ICD_IMPLANT S ICD_DFT DISCHARGE S ICD DFT S ICD DISCHARGE ECG SF36 DASI_QUES 10 DAYS FU PE S_ICD_DFT FOLLOW_UP 2 3 MONTHS FU PE ECG S_ICD_DFT FOLLOW_UP 6 MONTHS FU S_ICD_DFT FOLLOW_UP 12 MONTHS FU SF36 DASI_QUES S_ICD_DFT FOLLOW_UP FOLLOW_UP FOLLOW_UP 30 MONTHS FU SF36 DASI_QUES S_ICD_DFT FOLLOW_UP 1 2 Overview of visits and associated CRF s TV ICD VISIT BASELINE IE_CRIT DEMOGRAPHY DASI_QUES ICD IMPLANT RANDO TV_ICD_IMPLANT TV_ICD_DFT DISCHARGE TV_ICD_ DFT TV_ICD_ DISCHARGE ECG SF36 DASI_QUES UserManualeCRF
5. lt i v Comment DEMOGRAPHY Field involved in selected discrepancy Initials Sex Date of birth 1 Age Comment v Description D X DUMMY 1 Details of selected Type MULTIVARIATE discrepancy in List Review Status waiting review Action Send to CRA e Send to data manager Send to Investiocator e Click on a discrepancy in the list to display the details of that discrepancy in the Details section The fields that are involved in this discrepancy are indicated in the CRF by a dotted blue boundary e Incase fields from other pages are involved you can look at the values for these fields by clicking on Related values User Manual eCRF PRAETORIAN study Clinical Research Unit V2 05nov2012 Academic Medical Center University of Amsterdam Page 7 of 16 Nordkamp at T 0031 0 20 56 67731 L R OldeNordkamp amc uva ni For technical problems please contact Alden van Putten at T 0031 0 20 56 61911 at E cru oc amc uva nl If you have any questions regarding the study please contact Louise Olde a m Clinical Research Unit e f possible change the indicated data to solve the discrepancy The discrepancy will be closed automatically when the values are correct e Incase a multivariate discrepancy involves fields from more than one CRF page changing data to the correct values will not always automatically close the discrepancy See section 8 Validate of this manual for m
6. 3 2 2 Blank fields e To indicate that no data will be collected for parts or a complete CRF page you can set the page to blank When you are in the CRF page choose the Blank flag option from the toolbar see figure 5 Depending on the set up the CRF page one or more blocks of data are defined that can be put on blank To set a complete page to blank tick the Is Blank box in the header fields Figure 5 Toolbar data entry window Blank flag tool Investigator comment l l Highlight All Discrepamoes a ge l Save Delete this CRF page e The data indicated as blank will be gray on the CRF page and can not be entered To enter data again in those fields click on the Blank flag option in the tool bar and untick the blank CRF part or untick the Is Blank box 3 3 Date fields e Click on the date field and an icon will appear Click on the icon to display a calendar for date selection Simply click the desired date to enter it e Alternatively you can enter T for today s date Y for yesterday s date or L for last entered date e You can also enter dates manually in the format ddmmyyyy for instance 03062011 which will be converted by OC to 03 JUN 201 1 e lf the day or month of a date is unknown enter 99 instead e g for missing day 99MAY2011 for missing day and month enter 99992011 e lf the complete date is unknown enter 99999999 8 times a 9 In case the field is not mandatory you can lea
7. OC in this document is the name of the system web application where you enter your clinical data 2 Getting Started Use Internet Explorer and go to http www praetorian trial org clinical link e crf site to launch the eCRF link of the PRAETORIAN study Please note that using another browser than Internet Explorer may result in some functionalities of Oracle not working properly or not at all To access the production database enter your username and password and click on Login After logging in for the first time you are prompted to change your password Only after changing the password you can continue After logging in the Home tab of OC is opened see figure 1 You can always change your password by clicking the change password button at the top of the screen If you want to exit OC always use the Logout button 3 Data Entry In this section the entry of data in OC is explained in detail 3 1 Select and open a CRF page On the Home tab of OC make sure that the right study and site is selected right upper corner see figure 1 On the screen you will see the patients that are predefined for your site If you need extra patient numbers contact the study coordinator To narrow down the list of patients shown you can select a range of patients or just one in the search part of the screen and click Go see figure 1 To select patient s for data entry click in the checkbox es in the column Se
8. PRAETORIAN study Clinical Research Unit V2 05nov2012 Academic Medical Center University of Amsterdam Page 15 of 16 If you have any questions regarding the study please contact Louise Olde Nordkamp at T 0031 0 20 56 67731 L R OldeNordkamp amc uva ni d m For technical problems please contact Alden van Putten at T 0031 0 20 56 61911 at E cru oc amc uva nl Clinical Research Unit VISIT CRF 10 DAYS FU PE TV_ICD_DFT FOLLOW UP 2 3 MONTHS FU PE ECG TV_ICD_DFT FOLLOW_UP FOLLOW_UP 12 MONTHS FU SF36 DASI_QUES TV_ICD_DFT FOLLOW_UP FOLLOW_UP FOLLOW_UP 30 MONTHS FU SF36 DASI_QUES TV_ICD_DFT FOLLOW_UP User Manual eCRF PRAETORIAN study Clinical Research Unit V2 05nov2012 Academic Medical Center University of Amsterdam Page 16 of 16
9. F icons e Please note that the system times out after 30 minutes of inactivity Any changes not saved will be lost Figure 7 Explanation CRF icons Icon Description Icon Description The page has not been Page verified by ab created no data monitor entered _ Data not complete a Data changed needs F re verification by the monitor The page was created Tu Page approved by a but marked as blank investigator Te Data complete no m Data changed needs active discrepancies vy E re approval by the investigator errr At lease one active discrepancy is present that needs your attention Br Active discrepancy that needs attention by another role e g monitor 3 6 fa rete pages In this study you can add the following extra CRF pages to the already predefined pages namely Adver_Even Arrhythmia Medication S lcd_Disc S lcd_Fu S lcd_Prog S_Thresh S_Unexp_ Fu Tv lcd_Dis Tv lcd_Imp Tv lcd_Pr1 Tv lcd_Pro Tv lcd_Fol Tv_Thresh Tv_Thresho Tv_Unexp To add an additional page go to the appropriate visit select a patient click on Add Visit Page and select the appropriate page Press the Continue button and tick Apply e You can remove a complete CRF page and all data entered on that page by clicking on the trash can icon in the toolbar in the data entry window see figure 5 Enter a reason for deleting the page in User Manual eCRF PRAETORIAN study V2 05nov2012 Clinical Research Unit Academic Medical Cen
10. Incase upon accessing a field a magnifying glass icon appears next to it see figure 4 this indicates that you need to choose a value from a list of values for this field Open the list by clicking the icon and select the value by clicking on it Figure 4 list of values present for this field e Some CRF pages consist of more than 1 page You can see this by scrolling down but also extra options appear at the top of the CRF page to jump to the next page within this data entry screen see figure 3 e After completing data entry you can easily navigate to the next CRF page in this visit if applicable by clicking on the Next CRF button in the top right corner see figure 3 OC will ask you whether you want to save the data see also section 3 5 After saving the next CRF page will open e You can add a comment to a response field Either right click the field choose Investigator comment or select the field and choose the Investigator comment option from the Toolbar see also figure 5 and enter your comment UserManualeCRF PRAETORIAN study Clinical Research Unit V2 05nov2012 Academic Medical Center University of Amsterdam Page 4 of 16 If you have any questions regarding the study please contact Louise Olde Nordkamp at T 0031 0 20 56 67731 L R OldeNordkamp amc uva nl ad m For technical problems please contact Alden van Putten at T 0031 0 20 56 61911 at E cru oc amc uva nl Clinical Research Unit
11. Nordkamp at T 0031 0 20 56 67731 L R OldeNordkamp amc uva ni For technical problems please contact Alden van Putten at T 0031 0 20 56 61911 at E cru oc amc uva nl If you have any questions regarding the study please contact Louise Olde a m Clinical Research Unit User Manual for the Oracle on site eCRF for the PRAETORIAN study Click on the section name in the contents table below to directly go to the section in the text CONTENTS 1 Abbreviations and GETINILONS e sesnceccscusdecslseeninnssaisisieciscnncomdandetasanoscidnedosekavenddaaandeddauedeawntakedaceanedeaetaneadeedeneeenciaboes 2 2O N a E E E E T E E EEE T E E N eee 2 BDA EN a E E tect siniseepeheduiessiad Meds onmedtenxannioardinhansssaneems 2 3 1 Selectand open a CRF DAG Cvs caiwsccnctdunsansndudidonactehdaieindwosdededwh deansuecdewnduiehdensudiesddeusevntdemedeaisivenetannclawanatandets 2 SEE E E i E E A E E stance E E EEE E E E E AE EE AE E ES 4 ERA E TO NS E cc sre E E AT EEE sie E EE aot EEE EEE EE E EEE st 5 S EEIE e e E A A E E AE E E N E A E NET s SEEE e e E A E ee E A AE E N E E E E E E TT 5 A AEI EAT EE EENE A A AOE E EE A NE TE E NET 5 3 6 Adding deleting pages cceccccccssssececceeeececceeueeeeeceuusueeeecsaasececeesaueeeesseaueeeessuaueeeeessaaeeeeeessaeeseeessageeeess 6 4 Error discrepancy management cccccccseeeceeeceeeeeeeecaeeeeceeeeseeseeeeeseeeseeeeseeaeeeeesseeeceeesseaseeeeesseaeeeessssaeeeesensas 7 4 1 Creation of Discrepancies
12. RELICO x2 RELICO Open patient A aa Suna i selected len Ww O 7 x4 Unassigned pa on a Figure 2 Selected eCRFs Casebooks ORACLE RDC onsite Logout Change Password Help Casebooks Review Reports Home Logged in as Jolanda Strubel Site user PILOT1 Last Refresh 24 Aug 2011 11 34 5 Study and Site RELICO s 138201 Go vy and S stud o sie summary Patient Casebooks t Search 3 Patients Selected From Home Page Click to select other visit Casebook Spreadsheet Patients Previous 1 3 of 3 wi Next Casebook View RELICO Cen RFs revos raor ne visit if applicable Select Patients and Generate Patient Data Report v Go Add Visit Page Add Other Page Select All Select None Patient v1 Select Number Demo Vitals Vitals 1 oa E i 2 Click to update the status after entering Oa Mm 4 Single click icon or updating data oa H E to open CRF re Show next pages for this e Select the visit you want to enter data for see figure 2 Single click on a CRF icon to open the data entry window e The selected CRF page is now opened in a new window see figure 3 e Acomplete overview of visits and CRF pages per visit for the PRAETORIAN study is given in appendix 1 User Manual eCRF PRAETORIAN study Clinical Research Unit V2 05nov2012 Academic Medical Center University of Amsterdam Page 3 of 16 If you have any questi
13. ae J Go Refresh C Show Timestamps Patient Visit Date Open Select Number Name Date CRF Name Casebook Modified Verified Approved Locked CRF X1 DELIVERY 23 Jun 2011 POSTPARTUM INTERMIT X1 FU 1 WEEK 21 Jun 2011 DIARY_D1 INTERMIT X2 SCREENING 10 Jun 2011 DEMOGRAPHY _INEX INTERMIT F X3 DELIVERY 20 Sep 2011 PARTUS VERBLIJF m val mn a eeu ac uenoi iie FEA User Manual eCRF PRAETORIAN study Clinical Research Unit V2 05nov2012 Academic Medical Center University of Amsterdam Page 12 of 16 Nordkamp at T 0031 0 20 56 67731 L R OldeNordkamp amc uva ni For technical problems please contact Alden van Putten at T 0031 0 20 56 61911 at E cru oc amc uva nl If you have any questions regarding the study please contact Louise Olde a m Clinical Research Unit Figure 18 Skip pages with open discrepancies while verifying multiple pages 2 RDC Onsite Verify CRFs T Dialoogvenster van webpagina Verify CRFs Total Selected CRFs 3 With Discrepancies 0 Comment Cancel Continue http ms app t166 ict amc nl olsa oc rdcM a Lokaal intranet In case data were changed after the page was indicated as verified OC changes the status and the icon for that page to needs re verification see figure 16 You can search for these pages in the casebooks or review tab by selecting for the CRF status Verification field the option Awaiting Re verification Re verifying
14. d Discrepancy Open Active amp Other Approval All w Verification Al Patient CRF Source Casebook All v Visit All Y CRF Name All j fier i So Execute current Casebook Spreadsheet search criteria Patients Tevio 1 3 of 3 v Next Casebook View RELICO bal Visit v1 amp CRFs 9 rrevic 1 3 of 2 me Next Select Patients and Generate Patient Data Report v Go Refresh Select All Select None Patient V1 Select A Number Demo Vitals Vitals 1 o X1 2 inam am X3 7 2 any Sie E E E e f you want to select only one patient just enter the patient number in the first range box and leave the second box empty e lf you enter no criteria and press Go you will select all CRF pages present for your site Please note that this kind of search for all in the Review tab will only result in the pages for which data was entered On the Casebook tab search for all will also give the pages that have no data yet e Click on Clear to clear the current search criteria and to start a new search UserManualeCRF PRAETORIAN study Clinical Research Unit V2 05nov2012 Academic Medical Center University of Amsterdam Page 8 of 16 If you have any questions regarding the study please contact Louise Olde Nordkamp at T 0031 0 20 56 67731 L R OldeNordkamp amce uva nl For technical problems please contact Alden van Putten at T 0031 0 20 56 61911 at E cru oc amc uva nl C
15. date of informed consent and sometimes correcting the data will not automatically close the discrepancy These specific checks are run overnight but you can run them yourself to check whether you resolved a cross page discrepancy after correcting data e Go to the Casebooks tab Search for the appropriate patients and click the checkboxes in the Select column to select the patients e Choose Validate for the Select patients and option see figure 13 click on Go to run the validation procedure e Click the Refresh button In case there are still unresolved discrepancies check these again User Manual eCRF PRAETORIAN study Clinical Research Unit V2 05nov2012 Academic Medical Center University of Amsterdam Page 10 of 16 If you have any questions regarding the study please contact Louise Olde Nordkamp at T 0031 0 20 56 67731 L R OldeNordkamp amce uva nl For technical problems please contact Alden van Putten at T 0031 0 20 56 61911 at E cru oc amc uva nl Clinical Research Unit Figure 13 Extra validation of entered data ORACLE RDC Onsite Logout Change Password Help Casebooks RQview Reports Logged in as Jolanda Strubel Site user PILOT1 Last Refresh 23 Aug 2011 11 17 5 Study and Site RELICO 138201 Study and Site Summary Validate selected patients Patient Casebooks Patient Range x1 amp x4 GQ assigned Book Any M Show
16. e next page upon saving e When you save a page with incomplete data discrepancies might appear for instance for mandatory fields see also section 4 If you would like to save incomplete data to return to complete them at a later stage but do not whish Oracle to check the data you can change the setting of your current User Manual eCRF PRAETORIAN study Clinical Research Unit V2 05nov2012 Academic Medical Center University of Amsterdam Page 5 of 16 If you have any questions regarding the study please contact Louise Olde Nordkamp at T 0031 0 20 56 67731 L R OldeNordkamp amc uva ni For technical problems please contact Alden van Putten at T 0031 0 20 56 61911 at E cru oc amc uva nl am Clinical Research Unit Oracle session Open a CRF page and click on preferences in the right hand corner Set preferences to Prompt to save complete see figure 6 Upon saving you will now have the option to save the data as incomplete so no data validation checks are made for this page This setting is only for your current session Upon logging out and in again you need to change the preference again Figure 6 Change saving option for CRF page Preferences ae Prompt for Save Complete L Suppress Validation Error Alert Help Cancel OK e Inthe Casebook tab click on the Refresh button to show the new status of the CRF page See figure 7 for an overview of the meaning of the different CR
17. esh 23 Aug 2011 11 36 search result Study RELICO Site 136201 Patients Selected 3 TotalCRFs 12 Total Discrepancies SSS SS Q x3 Q Assigned Book Any z CRF Status Entry All v Approval All v Verification All v CRF Source Casebook All v Visit An v CRF Name AIl v Discrepancy Status Open Active amp Other v 101 Patient Range x1 More details for this discrepancy Clear Go Discrepancies Click to open associated CRF Refresh lt Previous 1 50 of Next 50 gt Patient Visit CRF Question Review Open Number Name Date Name Section Response Status Description Detail CRF x1 v1 11 feb 2001 DEMO MULTI MULTI UNREVIEWED Hello D X DUMMY 1 Have a good day El E X1 vi 11 feb 2001 DEMO MULTI MULTI UNREVIEWED D X DUMMY 1 E E Search result X1 v1 11 feb 2001 DEMO MULTI MULTI UNREVIEWED hallo D X DUMMY 1 met id 1000000009 E E User Manual eCRF PRAETORIAN study Clinical Research Unit V2 05nov2012 Academic Medical Center University of Amsterdam Page 9 of 16 If you have any questions regarding the study please contact Louise Olde Nordkamp at T 0031 0 20 56 67731 L R OldeNordkamp amc uva ni For technical problems please contact Alden van Putten at T 0031 0 20 56 61911 at E cru oc amc uva nl Clinical Research Unit 6 Audit Trail One of the requirements for a GCP study is the presence of an audit t
18. ified This can be done by searching for the appropriate pages in either the casebook or review tab see figure 17 e Enter the desired searching criteria and click on go e Select the pages that need to be indicated as verified from the search results e Choose the option Verify from the select CRFs and dropdown menu and click on go e tis possible to skip the pages that still have open discrepancies at this stage see figure 18 If you untick this box all selected pages will be verified regardless of the status of the discrepancies The pages are now indicated with the verify status in the overview no refresh is necessary To unverify pages select them in the overview and choose the option UnVerify from the select CRFs and dropdown menu and click on go Figure 17 Verifying multiple pages RDC Onsite Logout Preferences Change Password Help Home Casebooks Review Reports CRFs Discrepancies Investigator Comments Home Patient CRFs Logged in as Qacra Qacra CRA role PILOT1 Last Refresh 26 Oct 2011 11 33 Study Site 140201 Patients Selected 6 TotalCRFs 15 Se Patient Range Q I Q Assigned Book Any r v CRF Status Entry All vi Discrepancy Clean None or Closed v Approval All v Verification Not Verified v CRF Source Casebook All i Visit All v CRF Name All v et c
19. ld If the discrepancy results from a typing error or another error that can be solved directly choose cancel and change the data accordingly e lf you want to leave the discrepancy for now and close it later leave the action field empty and click on ok e If the data will not be changed choose the action Closed no resolution to indicate that the discrepancy is irresolvable Click on ok e Multivariate checks will give a pop up upon saving a CRF page You can resolve the discrepancy as indicated above for the univariate discrepancy e To review discrepancies for a certain CRF page at a later stage click the arrow on the right edge of the data entry window to open the Navigator pane see figure 8 In the list part each discrepancy is depicted with a coloured circle followed by multi or uni Figure 8 Navigation pane for discrepancy details gt RDC Onsite DE X1 V1 DEMO T Windows Internet Explorer ER ORACLE RDC Onsite Data Entry Preferences Help Study RELICO Site 138201 Patient X1 Casebook RELICO Jolanda Strubel Site user JMAA fs SPit asa x A Discrepancy Investigator Comment Open close navigator pane Highlight All Discrepancies Show All Discrepancies v Doc R9263601 visit Name DCI Date 5 068 7 Patient Ki Subevent Status muti n Site foummyt DCI ShortName ai E Investigator DCI Name Is Blank G
20. lect next to the patient icon see figure 1 choose Open patient casebooks and click the Go button OC now jumps to the Casebook tab where the casebooks CRF pages for the selected patients are shown per visit see figure 2 User Manual eCRF PRAETORIAN study gt gt Clinical Research Unit V2 05nov2012 Academic Medical Center University of Amsterdam Page 2 of 16 If you have any questions regarding the study please contact Louise Olde Nordkamp at T 0031 0 20 56 67731 L R OldeNordkamp amce uva nl ad m For technical problems please contact Alden van Putten at T 0031 0 20 56 61911 at E cru oc amc uva nl Clinical Research Unit Figure 1 Home tab with the Patient Search panel Logout to exto a JAN eet Ml ALEG Logout Change Password Help Select study and site Review f Reports Logged in as Jolagse Study and Site RELICO pel Site user PILOT1 Last Refresh 24 Aug 20 138201 M a cre Siiunalry News Patient Selection List No Records Found e Select range of Patient Sea patients to narrow Activities Review 101 Active Discrepancies r down list below Range A 3 Assigned Book Any Review Investigator comme x e Show All y Discrepancy Status All v Links oar jn a search on webearch Select All Select None Tick box es to Select 4 Patient Number Last Modified Casebook select patient s amp X1
21. linical Research Unit Figure 10 search in Review tab ORACLE RDC Onsite Logout Change Password Help Logged in as Jolanda Strubel Site user PILOT1 Last Refresh 23 Aug 2011 12 28 Summary search result Total CRFs 12 Patients Selected 3 Search Patient Range x1 Fj Q x3 Q Assigned Book Any v CRF Status Entry All v Discrepancy Open Active amp Other v Approval An vl Verification An v CRF Source Casebook Al w Visit an CRF Name All v Clear Go Patient CRFs Select CRFs and Generate Patient Data Report Go Refresh Cl Show Timestamps Select All Select None Patient Visit Date Open Select Number Name Date CRF Name Casebook Modified Verified Approved Locked CRF F X1 V1 11 feb 2001 DEMO RELICO E E X1 v1 11 feb 2001 VITALS RELICO E o x1 va 13 0kt 2001 SKIN RELICO E earch result oO xX2 V1 11 jun 2001 DEMO RELICO E O X2 V3 13 jun 2001 VITALS RELICO E F X2 ANNEX 14 jun 2001 TERM RELICO E e You can also search and show discrepancies directly Select Discrepancies on the Review Tab see figure 11 and perform the search as described before The search result gives a list of the discrepancies Click details for more information on the discrepancy Figure 11 Searching discrepancies in the Review tab ORACLE RDC Onsite Logout Change Password Help Summary Logged in as Jolanda Strubel Site user PILOT1 Last Refr
22. ons regarding the study please contact Louise Olde Nordkamp at T 0031 0 20 56 67731 L R OIdeNordkamp amc uva nl ad m For technical problems please contact Alden van Putten at T 0031 0 20 56 61911 at E cru oc amc uva nl Clinical Research Unit Figure 3 Data entry window E Sane tiie ORACLE RDC Onsite Data Entry Save button Preferences Help Study Site 288304 Patient X1 Casebook CPrevious CRF Next CRF ES Highlight ll Discrepancies v Ss geil Ef Goto previous next first last page in this CRF page Patient Visit VISIT2 Site Economische vragenlijst 1 Mobiliteit Ik heb geen problemen met lopen Ik heb enige problemen met lopen ES Copyright amp 2000 2007 Oracle All rights reserved 3 2 1 General e The following header fields see figure 3 for an example of header fields are enterable for this study Is Blank indicates whether the complete CRF page is marked as blank Visit date the date on which the data were collected e You can not select or change the patient number visit name or site name in the header these values are predefined e Field help texts will appear when you right click on the field e In fields where the comment auto calculated is added no data can be entered The value is calculated and will be displayed on the screen after you save the page as complete e For numeric fields use a point instead of a comma to enter the decimal place e
23. ore details e f you cannot resolve the discrepancy go to Action in the Navigator pane below Details see figure 8 and choose Closed no resolution in the dropdown menu Click on the Go button A new window opens in which you should indicate the reason for resolution or in this case for not resolving the discrepancy and press the OK button 5 Patient Search e You can search for CRF pages for patients using the search option on both the Casebook tab and the Review tab On the Review tab you can also search for discrepancies e Asearch on the Casebook tab will show the result for all patients per visit see figure 8 The result on the Review tab is given as one listing of all the results for all patients and visits see figure 9 e On both tabs you will find at the top of the screen the search part to enter search criteria see also figure 9 and 10 Here you can enter the desired patient range CRF status and the CRF status of the required CRF pages e Click on Go to execute the search The result is shown in the lower half of the screen Figure 9 Search in Casebooks tab ORACLE RDC onsite Logout Change Password Help Home L concoct D Review f Reports Logged in as Jolanda Strubel Site user PILOT1 Last Refresh 23 Aug 2011 12 32 03 Study and Site RELICO 138201 i Go Study and Site Summan Patient Casebooks ag Clear current Search a ren search criteria CRF Status Entry All a
24. rail In the audit trail you can see who edited which data when and why To access the audit trail in OC e Open a CRF page e To see whether any changes were made in data in the CRF page choose Audit history from the Highlight options in the toolbar see figure 12 e Click on the arrow at the bottom of the screen to open the Audit history pane e Click in the highlighted field on the CRF to display the audit trail for that field Please note that the first entry of a value is not shown here only the changes after first entry Figure 12 Audit trail in OC gt RDC Onsite DE X1 V1 DEMO T Windows Internet Explorer ORACLE RDC Onsite Data Entry Study RELICO Site 138201 Patient X1 Casebook RELICO Jolanda Strubel Site user Highlight Audit History J ee Sf ay Doc Visit Name DCI Date Fep Ja Study Name Visit DCI Time Site foummyt oci ShortName Investigator DCI Name Is Blank Comment DEMOGRAPHY Initials Ra Sex Open close Date of birth 3 DEC 1967 Audit trail Audit 1 Age aa history pane a F gt W lt Audit History Visit Date Date Changed From 13 APR 2011 19 39 15 13 APR 2011 Reason Comment CRA CORR Changed To 11 FEB 2001 By David De Koning Copyright 2000 2007 Oracle All rights reserved 7 Validate Multivariate discrepancies can involve multiple CRF pages e g date of follow up should be after
25. re 16 User Manual eCRF PRAETORIAN study Clinical Research Unit V2 05nov2012 Academic Medical Center University of Amsterdam Page 11 of 16 If you have any questions regarding the study please contact Louise Olde Nordkamp at T 0031 0 20 56 67731 L R OldeNordkamp amc uva nl ad m For technical problems please contact Alden van Putten at T 0031 0 20 56 61911 at E cru oc amc uva nl Clinical Research Unit e To unverify a page open the CRF page again and click on the verify icon Now you have the option to undo the verification Figure 16 Overview verification status pages RDC Onsite Logout Preferences Change Password Help Casebooks Review Reports Home gt Logged in as Qacra Qacra CRA role PILOT1 Last Refresh 26 Oct 2011 11 20 5 Study and Site _ a 140201 v Go Study and Site Summary Patient Casebooks Search 3 4 Patients Selected From Home Page Casebook Spreadsheet Patients Previous 1 1 of 1 Se Next amp Casebook View INTERMIT v Visit SCREENING i CRFs Prev ous 1 2 of 2 Next gt d Generate Patient Data Report x Go sit Page A 3 ige Refresh i z SCREEN Needs re verification Home Casebooks Review Reports Logout Preferences Change Password Help Select A TNE Demo_Irmtx F A X1 About RDC 4 5 3 Copyright 2000 2007 Oracle All rights reserved lt is also possible to mark multiple pages at once as ver
26. ter University of Amsterdam Page 6 of 16 If you have any questions regarding the study please contact Louise Olde Nordkamp at T 0031 0 20 56 67731 L R OldeNordkamp amc uva ni ad m For technical problems please contact Alden van Putten at T 0031 0 20 56 61911 at E cru oc amc uva nl Clinical Research Unit the comment field press Delete and Refresh the Casebooks view The page is now indicated as Page not created 4 Error discrepancy management 4 1 Creation of Discrepancies e Automatic checks of the correctness of entered data are done upon entering the data and leaving a field the so called univariate checks for instance range checks or upon saving a CRF page multivariate checks Multivariate checks can involve values entered on more than one CRF page e When a check finds incorrect data a so called discrepancy is created in the system The CRF icon will change colour according to the status of discrepancies in that page see figure 7 e Inthe CRF page itself the fields involved in a discrepancy can be highlighted by selecting Highlight the option All discrepancies in the toolbar see also figure 8 The fields are now coloured either yellow discrepancy that needs another persons role attention for instance the monitor red needs your attention or green discrepancy solved 4 2 Solving discrepancies e For univariate checks the discrepancy will pop up when you leave the fie
27. then follows the same steps as verifying the page NOTE only applicable for monitors To get a quick overview of all pages that need verification in your study you can also use the link Review non blank CRFs ready for initial verification on the home tab This will result in an overview in the review tab of all pages that have the status entry completed no open discrepancies and which are not verified as yet 9 Approval of CRFs For GCP studies it is necessary that paper CRFs with data entered are approved by signing by the principal investigator at each site For an eCRF the equivalent is the electronic signature or Approval as it is called in OC by the investigator To approve more than one CRF page e Goto the Review tab e Select in the Search pane the patient s that you want to approve sign see also section 5 patient search of this manual e Select Not Approved in the dropdown menu for Approval see figure 14 and set the other to the desired values or leave them on the default value to select all e Press Go to execute the search e Select the CRF pages that you want to approve e Choose Approve from the dropdown list for Select CRF s and and click Go UserManualeCRF PRAETORIAN study Clinical Research Unit V2 05nov2012 Academic Medical Center University of Amsterdam Page 13 of 16 If you have any questions regarding the study please contact Louise Olde
28. ve it empty e Save the page and choose in the Validation pop up window that appears for Action Closed no resolution This will resolve the discrepancy error that resulted from entering an incomplete date see also 4 2 on solving discrepancies 3 4 Time fields e The 24h format is used in OC e Time can be entered without a colon e g 1000 will be changed automatically to 10 00 e Incase of an incomplete time value please enter 99 for the missing part e g 08 99 e Incase the time value is unknown enter 99 99 when this is a mandatory field If the field is not mandatory please leave the field empty 3 5 Saving data e There are 3 different ways to save data upon completing data entry 1 Use the Save button in the toolbar to save your data You have the option to Note if you did not complete all fields on the page some sections of the CRF with no data entered may be greyed out which means that they are indicated as blank If you want to complete the missing data use the Blank flag tool to unmark the section and enter data see section 3 2 2 Use the Exit button see figure 3 you are prompted to do either of 3 things save the data discard changes made will not be saved or cancel you return to the CRF page Upon saving you will return to the Casebook tab 3 Use the Next CRF page button if applicable see figure 3 the same options are shown as for the Exit button except that you will go to th

ALGEMENE SOP STRUKTUUR

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