 |
Page History
This page tree describes how to amend trials currently registered and verified in CTRP.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. (Refer to Trial Processing Statuses.) Anchor
| Info |
|---|
| 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.
...
