Verifying CRFs 03-Mar-2016

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Cori Foster
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1 Verifying CRFs 03-Mar-2016

2 What is verifying CRFs? The verification process means Checking the entered data against the source data. 2

3 Studing Purpose After studying these slides, you may know: 1. Find CRFs to Verify/Re-verify 2. Verify CRFs 3. Redoing CRF verification 4. Verify Multiple CRFs 5. Undo Verification 3

4 Finding CRFs to Verify 1. Use a customized Activities link on the Home page: Review non-blank CRFs ready for initial verification 2. Select patients on the Home page and navigate to the Review CRFs page 4

5 Finding CRFs to Verify(Contd.) 3. Select patients on the Home page and navigate to the Casebooks page 5

6 Reviewing CRFs from the Data Entry Window Reviewing Data Reviewing Discrepancies Reviewing Verification History Reviewing Changes since Latest Verification Reviewing Audit History 6

7 Reviewing Data 1. Open a CRF in a Data Entry window. 2. Review data in the CRF fields. 3. Create a manual discrepancy if you find a discrepancy between source data and data entered in the ecrf. 4. Save the CRF if you create a manual discrepancy. 7

8 Reviewing CRFs from the Data Entry Window Reviewing Data Reviewing Discrepancies Reviewing Verification History Reviewing Changes since Latest Verification Reviewing Audit History 8

9 Reviewing Discrepancies Use the Review Discrepancies page, the Patient Casebooks page, or the Review CRFs page. 1. Open the Review Discrepancies page. 2. Sort by Description to find a group of the same type of multivariate discrepancy. 9

10 Reviewing Discrepancies(Contd.) 3. Select the Detail icon for a discrepancy. 10

11 Reviewing Discrepancies(Contd.) 4. Review the Related Values section of the Discrepancy Details pane. 5. Select one CRF icon after the other, to view both the contributing CRFs in adjacent windows. 11

12 Reviewing CRFs from the Data Entry Window Reviewing Data Reviewing Discrepancies Reviewing Verification History Reviewing Changes since Latest Verification Reviewing Audit History 12

13 Reviewing Verification History A CRF that has never been verified does not have a verification history. 1. Open the CRF in a Data Entry window. 2. Click the Verify icon in the toolbar. 3. Close the Verify CRF dialog box. 13

14 Reviewing Verification History(Contd.) History Details: Date Operation Changed By Comment 14

15 Reviewing CRFs from the Data Entry Window Reviewing Data Reviewing Discrepancies Reviewing Verification History Reviewing Changes since Latest Verification Reviewing Audit History 15

16 Reviewing Changes since Latest Verification 1. Search for CRFs that require re-verification. 16

17 Reviewing Changes since Latest Verification(Contd.) 2. Open a CRF in a Data Entry window. 3. Click the Highlight field in the toolbar, and select Changed since last verified from the list. 17

18 Reviewing Changes since Latest Verification(Contd.) 4. Right-click a field highlighted in blue, and select View Audit History. 5. Review the history of changes for the selected field. 6. Continue to review the changes to other fields in the CRF since the last verification. 18

19 Reviewing CRFs from the Data Entry Window Reviewing Data Reviewing Discrepancies Reviewing Verification History Reviewing Changes since Latest Verification Reviewing Audit History 19

20 Reviewing Audit History 1. Open a CRF in a Data Entry window. 2. Right-click a field and then select View Audit History. 3. Review the history of changes for the selected field. 20

21 Verifying CRFs from the Data Entry Window To verify a CRF: 1. Open a CRF in a Data Entry window. 2. Click the Verify icon in the toolbar to open the Verify CRF dialog box. 3. Save your changes. The verification actions available in the Verify CRF dialog box depends on the current status of the CRF. Based on the status of the CRF(Verify/Unverify/Re-Verify). 21

22 Redoing CRF Verification To redo the verification of a CRF: 1. Search for CRFs that need to be re-verified 22

23 Redoing CRF Verification(Contd.) 2. Review changes in the CRF after verification 3. Review the Audit History of changes in the CRF 4. Redo the verification of an individual CRF/a group of CRFs 23

24 Verifying Multiple CRFs 1. Open the Patient Casebooks page or the Review CRFs page. If the verify option does not appear in the list, either you do not have appropriate privileges, or your sponsor has not configured RDC Onsite for group verification. 24

25 Verifying Multiple CRFs(Contd.) 2.Enter a comment in the Verification Comment field, if you want. 3.Click Verify to proceed with the group verification. 4.Click Close to close the dialog box. 25

26 Undoing Verification of Multiple CRFs If you unintentionally verify a group of CRFs, you can reverse the action with the Undo Group Verification Option. 26

27 Undoing Verification of Multiple CRFs(Contd.) To undo the verification: 1. Open the Patient Casebooks page or the Review CRFs page. If the UnVerify option does not appear in the list, either you do not have appropriate privileges, or your sponsor has not configured RDC Onsite for the group undo verification. 27

28 Undoing Verification of Multiple CRFs(Contd.) 2. Enter a comment, if you want. 3. Click Unverify to proceed with undoing the group verification. 4. Click Close to close the dialog box. 28

29 Thank you!

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