Protocol Design

Key Considerations

  • It’s important that the study team reach out early to determine
    which office will handle the research contract review.

     

  • The contract will supersede specific legal terms in the protocol ONLY if the topic is addressed in both documents.
     

  • A well-defined protocol is essential for all projects, but particularly when there are:

    • Multiple funding entities

    • Subcontractors

    • Publication as a deliverable

    • Multiple arms

    • Correlative studies
       

Information to Gather

  • Do the procedures required by the protocol provide a unique emergency or urgent medical intervention?
     

  • Will any third parties receive data or information as part of the study? Will this involve PHI?
     

  • Is a Confidential Disclosure Agreement or Non-Disclosure Agreement needed with the third parties?
     

  • Is the third party’s participation detailed in the protocol or will it require separate IRB review​​


Reminders

  • Provide the final protocol to your appropriate clinical trials contracts office.
     

  • Ensure the title of the protocol conforms with the protocol in the agreement.
     

  • Identify whether any portion of the protocol that will not be performed by the University to the contracts analyst. This may include external services, correlative studies, subcontracts or separate research projects entirely.
     

  • Submit the protocol and informed consent to the IRB promptly and ensure the IRB approves the protocol and informed consent form

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