Reviewing CRFs from the Data Entry Window

After identifying CRFs that require verification, you can review them to ensure that they meet the requirements for verification. Your review of CRFs can include:

• Reviewing Data
  
• Reviewing Discrepancies
  
• Reviewing Verification History
  
• Reviewing Changes since Latest Verification
  
• Reviewing Audit History
  

Reviewing Data

To review entered data for errors:

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.

   To add a discrepancy, you can right click on the field to select Add discrepancy from the pop-up menu, or you can position the cursor in the discrepant field and select the Add discrepancy icon from the toolbar.

4. Save the CRF if you create a manual discrepancy.

Tip:

Click the Next CRF link to navigate through all CRFs without having to return to the Patient Casebook page or the Review page.

Reviewing Discrepancies

As a monitor or CRA, you may need to review discrepancies before you verify a CRF. See Managing Discrepancies for more information.

Reviewing Verification History

Before you verify a CRF, RDC Onsite lets you view the CRF's verification history, if any. A CRF that has never been verified does not have a verification history.

To view the verification history of a CRF:

1. Open the CRF in a Data Entry window.

2. Click the Verify icon in the toolbar. The Verify CRF dialog box displays the following information about the verification history, if any, for the CRF.

   Date — Displays the date and time of the entry in the Verification History table.

   Operation — Displays the action that caused a change in verification status: Verify or Undo Verify.

   Changed By — Displays the full name of the user who changed the verification status.

   Comment — Displays additional information about the Verify or Undo Verify action.

3. Close the Verify CRF dialog box.

Reviewing Changes since Latest Verification

The data in a CRF can undergo change even after the CRF has been verified. When this happens, RDC Onsite automatically changes the status of the CRF to Awaiting Re-Verification.

You should always review the changes in a CRF before you verify it again.

To review the changes to a CRF since the latest verification:

1. Search for CRFs that require re-verification:

   1. Open the Patient Casebooks page or the Review CRFs page.
   2. Expand the Search pane.
   3. Click the Verification field and then select Awaiting Re-Verification from the list. In the Single Patient Casebook page select the filter Requires Re-verification.

   4. Click Search to execute the search and refresh the display.

      Note:

      If you search for Verification status of Requires Verification, the search does not retrieve CRFs with an Awaiting Re-Verification status.
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. Fields updated since the last verification are highlighted in blue. Note that fields whose only update is an update to the investigator comment are highlighted.
4. Right-click a field highlighted in blue, and select View Audit History. The Audit History pane opens at the bottom of the Data Entry window.
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.

For more information, see:

• Finding Non-highlighted Changes in a CRF
  

Finding Non-highlighted Changes in a CRF

When you select Changed since last verified in the Highlight field in the Data Entry window, RDC Onsite does not highlight fields that have undergone the following changes:

• If updates were restricted to discrepancies, RDC Onsite does not highlight the associated fields. To locate such cases:

  1. Click the Verify icon in the Data Entry window toolbar to find the date of the latest verification in the verification history.
  2. Review the Discrepancy History to identify any updates since the last verification.
• If the layout of a CRF was modified, the CRF status could revert to Awaiting Re-Verification, even without any data updates.

Follow your sponsor's instructions for re-verifying CRFs with non-highlighted changes.

Reviewing Audit History

As a monitor, you need to review the changes to a CRF, especially the changes made to a CRF that was already verified. The Audit History pane provides comprehensive information on the changes to each field in a CRF.

To view the history of the changes to a field:

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

Note:

The Audit History pane does not include those changes made to discrepancies or investigator comments. You can, however, view the Discrepancy History and the Investigator Comment History for information on those updates.

To view other CRF creation history - Generate the CRF History report to view other CRF history not visible in the audit pane, such as the CRF creation and any deleted data rows.

1. Open a CRF in a Data Entry window.
2. Right-click a field and then select View Audit History. The Audit History pane opens at the bottom of the Data Entry window.

3. Review the history of changes for the selected field.

   Note:

   Generate the CRF History report as above to view other CRF history not visible in the audit pane, such as the CRF creation and any deleted data rows.