Reviewing CRFs from the Data Entry Window

After identifying CRFs that require review, you can review them individually to ensure they meet your requirements for stating that your review is complete. Your review of CRFs can include:

• Reviewing Data
  
• Reviewing Discrepancies
  
• Viewing Review History
  
• Reviewing Changes Since Latest Review Complete
  
• Reviewing Audit History
  

Reviewing Data

To review entered data for errors:

1. Open a CRF in the Data Entry window.
2. Review data in the CRF fields.

3. Create a manual discrepancy if you find a problem with data entered in the CRF.

   Tip:

   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 created a discrepancy.

Tip:

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

Reviewing Discrepancies

Your role may require that you review discrepancies before you complete your review. See Managing Discrepancies for more information.

Viewing Review History

RDC Onsite lets you view custom review history for a CRF, if any.

Note:

Changes in review status that were applied as a result of changes to the custom review type requirements, not as a result of user action do not appear in the review history. However, administrators can retrieve this information by querying the columns crt_list and allow_crt_rn in the DCIS and DCIS$JN tables.

To view the custom review history of a CRF:

1. Open the CRF in a Data Entry window.

2. Click the Custom Review icon in the toolbar. The upper pane of the Custom Review dialog box displays the following information about the review history, if any, for the CRF.

   Date — Displays the date and time of the CRF custom review status change.

   Operation — Displays the action that caused a change in review status: either an explicit change in custom review type status to Required, Not Required, or Complete, or a CRF Update, resulting in a new status of Awaiting Re-Review.

   Changed By — Displays the full name of the user who changed the review status or updated the CRF.

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

3. Close the CRF Review dialog box.

Reviewing Changes Since Latest Review Complete

If data in the CRF is entered or updated after you complete your review, RDC Onsite automatically changes the status of the CRF to Awaiting Re-review. You must review the changes in such a CRF before you set its status to Review Complete again.

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

1. Search for CRFs awaiting re-review. See Finding CRFs that Require Re-review.

   Note:

   If you search for Review status of Requires Review, the search does not include CRFs with an Awaiting Re-review status.
2. Open a CRF in a Data Entry window.
3. Click the Highlight field in the toolbar, and select Changed since last reviewed from the list. Fields updated since the last review 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, displaying the complete audit history for the field.
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 review.

For more information, see:

• Finding Non-highlighted Changes in a CRF
  

Finding Non-highlighted Changes in a CRF

When you select Changed since last reviewed in the Highlight field in the Data Entry window, RDC Onsite does not highlight fields for which updates were restricted to discrepancies. To find such changes:

1. Click the Custom Review icon in the Data Entry window toolbar to establish the date of the latest review complete status change.
2. Review the Discrepancy History to identify any updates since the last review complete status change.

Reviewing Audit History

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.

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

Generate the CRF History report to view CRF history not available in the audit pane, such as the CRF creation, prior history for any deleted data rows, and/or history prior to the CRF being deleted.