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Amended trial validation does not pertain to Abbreviated trials. |
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.
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After you reject an amendment, the system verifies the rejection in a message and returns you to the Trial Identification page.
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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, see Checking In and Checking Out Trials.
- 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.
Include Page Amendment Reason Codes - Include v4.4 Amendment Reason Codes - Include v4.4 - Click Save.