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Submitting an Amendment to the GCRC

To ensure scheduling of appropriate personnel and resources for specifically defined protocol visits and to allow the GCRC to comply with reporting requirements, all protocol changes must be submitted to the GCRC in the form of an amendment request. Clear delineation of protocol changes and associated changes to the GCRC 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 GCRC 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

Jennifer Raymond, Staff Assistant
Baird 715, Tel. (802) 847-3769
email: jennifer.raymond@vtmednet.org

Last modified September 12 2008 03:27 PM