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| Use the Amend Trial feature when changes substantively alter the treatment administered; and/or the study design; and/or the sites in which patients are being enrolled on the trial. Amendments include all changes (and updates) since the last amendment to the protocol was submitted. (See Examples of Amendments.) |
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. |
| What types of trials can be amended? | Only National, Externally Peer-Reviewed, and Institutional trials that have been registered with the CTRP previously. |
| 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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