Validate the trial IND/IDE details for Complete trials only.
IND/IDE validation does not pertain to Abbreviated trials.
For Complete trials, ensure that no duplicate IND/IDE records were registered. If a duplicate exists, use the Protocol document to verify which record is correct. If you are unable to determine the correct record, you may contact the trial submitter to request verification.
How to Review Trial IND/IDE Details
- 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 IND/IDE.
The Trial IND/IDE Information page appears.- Do one of the following to continue:
- To add IDE or IND information if no records are displayed, click Add and follow the instructions provided in Abstracting INDs and IDEs.
- To modify an existing record, click the Edit icon and follow the instructions provided in Abstracting INDs and IDEs.
- To delete a record, click the Delete icon.
- If you made any changes, click Save.
