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Comment: Moved the contents of the Info box to the Amendment and Update rows on the "Submitting Clinical Trial Data" page.

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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.

Info

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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