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This page tree describes how to use CTRP to amend clinical trials. The ability to amend a trial depends on multiple factors, as described in the following table:
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 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?

A trial owner can amend a trial with any trial status.

For CTRP Trial Status values, refer to Trial Status Values in the CTRP and and Expanded Access Statuses.

Which parts of a trial record can be amended?

Any part except:

  • NCI trial identifier number
  • NIH grant number
  • IND/IDE serial number

Note: The NIH grant number and IND/IDE serial number are reviewed by the CTRO during the amendment abstraction process and updated, when applicable.

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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