This page tree describes how to use CTRP to update clinical trials that are currently registered and verified in CTRP. The ability to update a trial depends on multiple factors, as described in the following table:
Factor | Description |
---|---|
Who can update 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 updated? | Only trials that have been registered with the CTRP previously. |
At which trial processing statuses can a trial be updated? | Only trials that have been previously accepted. (That is, the processing status must be Accepted or a subsequent processing status.) For information, refer to Trial Processing Statuses. |
You can also update the trial status and trial status start/completion dates without having to update other trial details. For instructions, refer to Updating Trial Statuses.
Use the Update Trial feature when changes to the trial do not substantively affect the scientific conduct of the study, the study design, and/or the sites in which patients are enrolled on the trial. Update Trial also accommodates certain protocol document changes. (For instructions, refer to Protocol Document Updates.)
Use the Amend Trial feature---for Complete trials only---when changes to the trial involve changes to the protocol document that require IRB approval.
For instructions, refer to the following pages:
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