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5 Configuring Custom Review Types

To facilitate centralized monitoring in RDC Onsite, you can create custom review types, which are similar to the predefined Verify and Approve review types. By defining custom review types, you enable and can track reviews performed by users with a specific role, such as data manager, safety expert, or adjudicator.

You create custom review types and their corresponding privileges in the CUSTOM REVIEW TYPE Installation Codelist in Oracle Clinical. This codelist comprises all user-defined review types and the privilege required for each review type. After defining a custom review type, still in Oracle Clinical, you must assign its custom privilege to RDC users so that they can perform custom reviews.

Each review type you define has a set of five possible statuses that can be assigned to CRFs: No Review Status, Review Required, Review Undone, Awaiting Re-review, Review Complete, and Review Not Required. These statuses are visible next to the CRF icon to users with privileges.

The system reverses a Review Complete status for a CRF to Awaiting Re-review under the same circumstances in which it reverses Approved and Verified statuses, with either data or discrepancy updates. However, it does not reverse the Complete status after form version migration.

5.1 Adding Custom Review Types

1. Open Oracle Clinical.

2. Navigate to Admin, Reference Codelists, and select Installation Codelists.

   The Maintain Installation Codelist window opens.

3. From the Query menu, select Enter Query.

4. Type CUSTOM REVIEW TYPES in the Name field and press F8.

   The codelist information is retrieved.

5. In the Reference Codelist Values section, fill in the Long Value field with a name for the new custom review type, such as SAFETY_REVIEW or DM_REVIEW.

6. Fill in the Short Value field with the name of the privilege required to perform that type of review, such as UPD_SAFETY or UPD_DMREV.

7. To activate the custom review type, select the Active checkbox.

8. Optionally, you can store details about the custom review type in the Description field.

9. Repeat steps 5 through 8 to add more custom review types and privileges.

10. Click Save when you have finished defining custom review types.

Once you activate and save the codelist values, the new privileges can be assigned to individual users from Study Security or Site Security, under the Users and Roles menu in Oracle Clinical.

For more information, also see:

• "Securing RDC Onsite"

• ”Performing Custom Reviews” in the Oracle Clinical Remote Data Capture Onsite User's Guide