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Validate the regulatory information for Complete trials that require XML documents for submission to ClinicalTrials.gov.

Regulatory information validation does not pertain to Abbreviated trials.

These instructions pertain to complete trials that require XML documents for submission to ClinicalTrials.gov.

How to Validate Regulatory Information

  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 Regulatory Information.
    The Regulatory Information page appears.

  4. Follow the instructions provided in Abstracting Regulatory Information.
  5. If you made any changes, click Save.
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