Page History
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Submission Type | Description |
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Registration | Use the Register Trial feature for a trial that has not been registered with CTRP previously. |
Amendment | Use the Amend Trial feature---for Complete trials only---when changes to the trial involve changes to the protocol document that require IRB approval. 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. (Refer to Examples of Amendments.) |
Update | 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.) |
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