Amendments apply to Complete trials only.
There is little difference between validating an original submission and an amended version other than the trial’s history and access to additional trial-related documents.
For amended trials, you can change additional elements specific to the amendment as follows:
- Amendment date and amendment number on the Trial History page. See Processing Trial History Information .
- Assigned Amendment Reason Code on the Trial History or Trial Validation page.
Rejecting Amended Trial Submissions
After you reject an amendment, the system verifies the rejection in a message and returns you to the Trial Identification page. The Last Submitter, displayed in the heading across the top of the page, reverts to the person who submitted the trial prior to the amendment submission.
How to Change an Amendment Reason Code
- Select a trial to validate by following the instructions in Selecting Trials that Require Validation. The Trial Identification page displays the trial details.
On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)
- On the Validation menu, click Trial Validation, and scroll to the bottom of the Trial Validation page.
- In the Amendment Reason Code drop-down list, select a valid reason code. The following table lists valid reason codes.
Reason Code
Definition
Administrative
Amendment submitted for errors or changes to non-scientific data
Example: A lead organization’s address changesScientific
Amendment submitted for errors or changes to the trial design
Example: A trial advances from Phase 1 to Phase 2Both
Amendment submitted for both administrative and scientific reasons
- Click Save.
