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You are here: Research at Carolina » OCT Home » Handbook: Clinical Trial Processing » Part I: Getting Started » Processing an Amendment to the Clinical Trial Agreement

Processing an Amendment to the Clinical Trial Agreement

Use the flow list below to determine the process you should follow.

Does the amendment change the financial terms of the contract?
- YES:
  - Submit the following to OCT:
    - Amendment
    - Review Request form
    - Proposal packet (see footnote)
- NO:
  - Does the amendment change the timeline and/or P.I. only?
    - YES:
      - SIGN the amendment. Submit the following to OCT:
        
        Amendment
        
        Review Request form
    - NO:
      - Submit the following to OCT:
        
        Amendment
        
        Review Request form

* Proposal packet for amendments must include a copy of the most recent IRB approval, informed consent form(s), and the most current protocol in addition to the required forms. If the protocol has not changed, a memo stating so will be accepted.