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This page tree describes how to use CTRP to register, amend, and update clinical trials. The following table describes the circumstances in which you should use each submission type:
Submission TypeDescription
RegistrationUse the Register Trial feature for a trial that has not been registered with CTRP previously. For more information and instructions, refer to Registering New Trials. 
Amendment

Use the Amend Trial feature (for Complete trials only) when changes to the trial involve changes to the protocol document that require Investigational Review Board (IRB) approval. Amendments include changes that substantively alter any of the following elements:

  • The treatment administered.
  • The study design.
  • 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. For more information and instructions, refer to Amending Complete Trials, including Examples of Amendments.

UpdateUse 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 more information and instructions, refer to Updating Trials, including Examples of Protocol Document Updates.

For more information and instructions, refer to the following pages:

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