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FactorDescription
Who can amend a trial?Only the trial owner. A trial may have more than one owner. To request ownership of a trial, contact your Site Administrator. (If you are a Site Administrator, refer to Managing Trial Ownership.)
What types of trials can be amended?Only National, Externally Peer-Reviewed, and Institutional trials that have been registered with the CTRP previously. For information, refer to CTRP Trial Categories, Study Sources.
At which trial processing statuses can a trial be amended?Only trials that have reached the Abstraction Verified Response or Abstraction Verified No Response processing status. For information, refer to Trial Processing Statuses. The CTRO reviews and abstracts amended trial data just as it does with original submissions.
At which trial statuses can a trial be amended?Only trials that have reached the In Review or Approved trial status. You can not amend trials in the Complete, Administratively Complete (Terminated), or Withdrawn status. For informationvalid ClinicalTrials.gov recruitment values, refer to to Trial Status Values in the CTRP and ClinicalTrials.gov and Expanded Access Statuses.
Which parts of a trial record can be amended?

Any part except:

  • NCI trial identifier number
  • NIH grant number
  • IND/IDE serial number

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