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  1. Select a trial to validate by following the instructions in Selecting Trials that Require Validation. The Trial Identification page displays the trial details.
  2. On the Trial Identification page, check out the trial. For instructions, see Checking In and Checking Out Trials.

  3. On the Validation menu, click Trial IND/IDE.
    The Trial IND/IDE Information page appears.

    IND IDE Information section of the Trial IND IDE pageImage Removed

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  4. 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.
  5. If you made any changes, click Save.