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The ability to amend a trial depends on multiple factors, as described in the following table:
Factor | Description |
---|---|
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. |
At which trial statuses can a trial be amended? | Only trials that have reached the In Review or Approved trial status. For information, refer to Trial Status Values in the CTRP and ClinicalTrials.gov. |
The CTRO reviews and abstracts amended trial data just as it does with original submissions.
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