Reviewing CRFs from the Data Entry Window

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

• Reviewing Data
  
• Reviewing Discrepancies
  
• Reviewing Approval History
  
• Reviewing Changes since Latest Approval
  
• 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. Change data as required.
4. Save the CRF, if you change data.

Tip:

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

Reviewing Discrepancies

As an investigator, you may need to review discrepancies before you approve a CRF. See Managing Discrepancies for more information.

Reviewing Approval History

Before you approve a CRF, RDC Onsite lets you view the CRF's approval history, if any. A CRF that has never been approved does not have an approval history.

To view the approval history of a CRF:

1. Open the CRF in a Data Entry window.

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

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

   Operation — Displays the action that caused a change in approval status: Approve or Undo Approval.

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

   Comment — Displays additional information about the Approve or Undo Approval action.

3. Close the Approve CRFs dialog box.

Reviewing Changes since Latest Approval

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

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

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

1. Search for a CRF that needs to be re-approved:

   1. Open the Patient Casebooks page or the Review CRFs page.
   2. Expand the Search pane.
   3. Click the Approval field and then select Awaiting Re-Approval from the list.

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

      Note:

      If you set the Approval field to Not Approved, the search does not retrieve CRFs with an Awaiting Re-Approval status.
2. Open a CRF in a Data Entry window.
3. Click the Highlight field in the toolbar, and select Changed since last approved from the list. Fields updated since the last approval 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 approval.

For more information, see:

• Finding Non-highlighted Changes in a CRF
  

Finding Non-highlighted Changes in a CRF

When you select Changed since last approved 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 Approve icon in the Data Entry window toolbar to establish the date of the latest approval.
  2. Review the Discrepancy History to identify any updates since the last approval.
• If the layout of a CRF was modified, the CRF status reverts to Awaiting Re-Approval even without any data updates.

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

Reviewing Audit History

As an investigator, you need to review changes to a CRF, especially the changes made to a CRF that was already approved. 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.