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This section describes how to amend trials currently registered and verified in CTRP.

About Trial Amendments

In your role as trial owner, you can amend National, Externally Peer-Reviewed, and Institutional trials that have been registered with the CTRP previously and have reached the Abstraction Verified Response/No Response processing status. (See Trial Processing Statuses.) 

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You can amend a trial you submitted or own if the trial status is In Review or Approved. (See Trial Status Values.)

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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 CTRO reviews and abstracts amended trial data just as it does with original submissions.

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titleThe ability to amend a trial is restricted by its trial status

You can not amend trials in the Complete, Administratively Complete, Withdrawn, or Terminated statuses.

Most of the information, including documentation, that is required for original submissions is also required in amendments. To ensure that these requirements are met, you can review, edit, and print your amended data using the Registration features prior to submission.

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