University of Vermont

University of Vermont Clinical Research Center

Submitting Amendment

Submitting an Amendment to the CRC

To ensure scheduling of appropriate personnel and resources for specifically defined protocol visits and to allow the CRC to comply with reporting requirements, all protocol changes must be submitted to the CRC in the form of an amendment request. Clear delineation of protocol changes and associated changes to the CRC Resource Request Form and Lay Summary/Consent will facilitate a rapid review.

Amendment Application Process

  • Completion of the IRB Amendment Form. Identify and justify specific changes.
  • Completion of the CRC Resource Request Form listing resources needed for only the amendment
  • Submission of the revised protocol (if necessary)
  • Submission of the revised consent forms/HIPAA (if necessary)

Submission

  • Deadline: Second Wednesday of each month unless requesting administrative approval.
  • Format: Submit electronically as MS Word or PDF document.

Follow-up

  • Email will be sent with notification of action.
  • The amendment changes are not in effect until you have received notification of approval.

Contact

Lee Devino
Tel. (802) 847-2793
Email: eileen.devino@vtmednet.org

Last modified February 06 2014 02:31 PM

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