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This page tree describes how to use CTRP to amend trials currently registered and verified in CTRP.
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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.) |
clinical trials. 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. 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| You can not amend trials in the Complete, Administratively Complete (Terminated), or Withdrawn status.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 valid ClinicalTrials.gov recruitment values, 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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| title | The ability to amend a trial is restricted by its trial status |
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| and Expanded Access Statuses. | |
| Which parts of a trial record can be amended? | Any part except:
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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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