Finding CRFs to Verify

To review patient CRFs and verify the data against the source data, you can:

• Use a customized Activities link on the Home page
• Select patients on the Home page and navigate to the Review CRFs page
• Select patients on the Home page and navigate to the Casebooks page

If there is an active patient SDV plan, and you have the necessary privileges (BROWSE_VERIFY or higher), you can search for Patients requiring 100% SDV. The results include both patients with and without entered data. In order to retrieve only patients with data, use the CRF Status Verification search field, selecting Requires Verification. CRFs requiring source data verification have a V icon.

For more information, see:

• Using a Customized Activities Link on the Home Page
  
• Selecting Patient Casebooks or CRF Review Tabs Directly
  

Using a Customized Activities Link on the Home Page

By default, the Activities section on the Home page includes a Review non-blank CRFs ready for initial verification link. This link has built-in search criteria that automatically finds only those CRFs that are ready for verification, and then displays those CRFs on the Review CRFs page.

Your sponsor can customize the Activities links. They can choose to create additional links, define different search criteria for links, rename links, or make some links unavailable. The links available to you depends on how your sponsor customized the RDC Onsite application.

To use the Activities link to find CRFs for verification:

1. Select the Review non-blank CRFs ready for initial verification link in the Activities section on the Home page.

   The link navigates to the CRF Review page, which lists all CRFs satisfying the criteria specified by the activity.

   Note:

   The blank Verified column indicates that the CRF has not been verified.

2. Expand the Search pane to view the criteria in effect as a result of selecting the activity.

   The non-customized activity displays only CRFs with status Entry or Pass 2 Complete that are not verified and have no open discrepancies. If Partial Source Data Verification is implemented for your site, the CRFs page lists only those CRFs that require source data verification according to the SDV Plan in place.

3. Click Reset to specify different search criteria, if needed.
4. Click Search to refresh the page according to your new criteria.

Selecting Patient Casebooks or CRF Review Tabs Directly

You can select specific patients for review on the Home page, and then navigate to the Review CRFs page to view the CRFs ready for verification. If a patient SDV plan is in effect for your site and you have the appropriate privileges, patients requiring SDV are identified in the Home page. If desired, you can select those patients individually, or you can simply Search for Patients requiring 100% SDV.

Alternatively, select your preferred RDC page directly, using the tabs, then enter the desired CRF search criteria to retrieve all CRFs requiring verification. This may be a better approach if you have an SDV plan where some patients require 100% SDV, but the remaining patients require SDV for critical CRFs only.

To select patients and view CRFs ready for verification:

1. Open the Home page and expand the Search pane.
2. Specify patient search criteria. For example, you can specify a patient range, patients assigned to a particular casebook (study protocol), or patients with no open discrepancies or with partial SDV in place, Patients requiring 100% SDV.
3. Click Search to refresh the patient list according to your criteria.

4. Select one or more patients for review from the Patients list. In order to do this you can click one row and then use the Ctrl + A keys to select all the patients displayed.

   Alternatively, you can click on the table header for the patient icon to select all the patients.

5. Note:

   You can use combinations of keys including Ctrl on all supported devices except for iPad.

6. Click the Action menu and then select Multi-Patient View, Single Patient View or Review CRFs from the list.

   Note:

   If your SDV plan includes both a patient and a CRF component, this method will not necessarily retrieve all CRFs requiring verification. You will be missing patients who do not require 100% SDV but who have critical CRFs requiring verification. In this case, you should simply search for CRFs requiring verification, either using the activity link or your own search criteria.

   Depending on your selection, the appropriate page opens:

   • The Review CRFs page displays all entered CRFs for the selected patients.
   • The Patient Casebooks page displays all entered and expected CRFs for the selected patients in spreadsheet format. See Using the Patient Casebooks Page for information on navigating in the Patient Casebooks page.
7. Expand the Search pane to specify CRF-level criteria, such as verification status, entry status, or discrepancy status.

8. Click Search to refresh the CRF list after selecting additional criteria.

   To reset your patient selection entirely and specify a different search, click Reset.