Finding CRFs for Approval

To review patient CRFs and approve the data, you can:

• Using a Customized Activities Link on the Home Page
  
• Selecting Patients and Navigating to the Review CRFs Page
  
• Selecting Patients and Navigating to the Patient Casebooks Page
  

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 approval link. This link has built-in search criteria that automatically finds only those CRFs that are ready for approval, 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 default Activities link to find CRFs for approval:

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

   The Review CRFs page lists all the patients and their CRFs. If the Approved column is blank, then the CRF is not approved. 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.

2. Expand the Search pane to view the criteria in effect as a result of selecting the activity.
3. Click Reset to specify different search criteria, if needed.
4. Click Search to refresh the page according to your new criteria.

Selecting Patients and Navigating to the Review CRFs Page

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 approval.

To navigate to the Review CRFs page and view CRFs ready for approval:

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.
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 that, 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 cells.

   Note:

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

5. Click the Action menu and then select Review CRFs from the list.

   The Review CRFs page opens, displaying all entered CRFs for the selected patients.

6. Expand the Search pane to specify CRF-level criteria, such as verification status, entry status, or discrepancy status.

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

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

Selecting Patients and Navigating to the Patient Casebooks Page

You can also select specific patients for review on the Home page, and then navigate to the Patient Casebooks page, instead of the Review CRFs page, to view the CRFs ready for approval. Navigating to the Patient Casebooks page lets you review CRFs in a casebook spreadsheet format instead of a list format.

To navigate to the Patient Casebooks page and view CRFs ready for approval:

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.
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 that, 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 cells.

   Note:

   You can use combinations of keys including Ctrl on all supported devices except for iPad.
5. Click the Action. menu and then select Multi-Patient View from the list.
6. The Patient Casebooks page opens, displaying all entered and expected CRFs for the selected patients in spreadsheet format. Each row of icons represents data for a single patient. 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.

Note:

When you specify CRF-level criteria, the empty CRF icons are not displayed. Ordinarily, these icons represent data that is expected according to the patient's casebook definition.

However, when CRF-level search criteria are in effect, cells where data has not been entered are blank. If patients within the current set do not have data for a particular CRF, the column is not displayed. This feature allows for a more compressed view of patient CRFs.