Approving Multiple CRFs

You can approve multiple CRFs simultaneously from the Patient Casebooks page or the Review CRFs page. The group approval option is available only if you have approve privileges, and if your sponsor has configured RDC Onsite to allow it.

To approve multiple CRFs:

  1. Open the Patient Casebooks page or the Review CRFs page.

    • From the Multi-patient casebook page, select one or more patients whose CRFs you need to approve. Click the Action menu and select Approve from the list.
    • From the Single patient casebook page, select one or more visits whose CRFs you need to approve. Click the Action menu and select Approve from the list.
    • From the Review CRFs page, select one or more CRFs to approve. Click the Action menu and select Approve from the list.

    Note:

    If the Approve option does not appear in the list, either you do not have appropriate privileges, or your sponsor has not configured RDC Onsite for group approval.

    The Group Approval dialog box opens and displays the following information:

    • The number of CRFs selected
    • The number of selected CRFs with open discrepancies
    • The number of unverified CRFs
    • The number of patients you selected (if you started with a patient selection from the Multiple Patients View of the Patient Casebooks page.)
  2. Enter a comment in the Approval Comment field, if you want.
  3. In the Exclude set of options, clear the Exclude CRFs with discrepancies check box if you want to approve such CRFs.

    Other options you have listed in the Exclude area:

    • Non-migrated CRFs entered from Oracle Clinical or RDC Classic
    • Batch Loaded CRFs

    These two options are not checked by default.

  4. Choose by clicking the checkbox corresponding to one of the options listed in the Include section, if this is the case:

    • Verified CRFs only
    • CRFs for this visit only (Otherwise, all visits for the selected patient(s)).
  5. Click Continue to proceed with the group approval.

    RDC Onsite approves all the selected CRFs. A dialog box reports when the approval is complete, and displays the total number of CRFs that were approved.

  6. Click Ok or on the background page to close window.

RDC Onsite automatically refreshes the page and updates the approval status of the affected CRF icons.

Note:

The number of CRFs approved may be less than the number of CRFs selected for any of the following reasons:

  • Any of the optional checkboxes is selected, depending on the settings from Oracle Clinical.
  • The CRF is already approved.
  • The CRF has a database lock (another user or a validation procedure is updating the CRF).
  • The CRF has an Oracle Clinical lock.
  • The CRF is entered from another site.
  • The CRF is at status Received or Entry Started.