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Comment: Added a table and copied information into it from the "In your role as trial owner" paragraph.

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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:

FactorDescription
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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