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• Before you accept a trial, verify the following trial characteristics:

  • Distinctiveness. Verify that the trial is not a duplicate of one previously registered and accepted in the CTRP.

    Info

    The CTRP system checks for duplicate trials by ClinicalTrials.gov identifier. However, it does not check for duplicate titles or other aspects of the trial. If you find a duplicate trial, decide which is correct as per the Protocol document, and then reject the other. If the system detects that there is an existing trial with the same ClinicalTrials.gov ID when you click Save on the General Trials Details page during validation, the system displays an error message. In order to save the trial information successfully, you must first change the ClinicalTrials.gov ID.

  • Appropriateness. For example, the CTRO accepts only trials submitted by a lead organization, and not a participating site in the case of a multi-site trial with an existing coordination center.

  • Completeness. For example, if a given type of document is missing, verify that it is included in another trial document.
  • Accuracy. For example, verify that the principal investigator’s information is correct.
  • Consistency. For example, verify that the Protocol document is consistent with the submitted trial details.
• If the trial contains incorrect information that you can not modify or verify, place the trial on hold. For instructions, refer to Putting Trial Processing On Hold .

• If you determine that a trial is an invalid submission, search for valid submissions in the CTRP database and reject the invalid trial submission.

• When all required fields contain information and you have established that all trial information is correct, accept the trial to make it available for future abstraction.

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