Industry Protocols

Studies that are industry-sponsored and involve an intervention for the patient must be vetted by a TDT and then reviewed by the PRMC Full Committee. Once PRMC approval is granted, the protocol must be submitted to the IRB.

IRB submission requirements (PDF)

Initial Protocol Submission

  • UVMCC Clinical Research Protocol Submission Form completed in full and presented to/signed by TDT members of study disease site if applicable (1 hard copy and 1 on the Commons). TDT meetings are listed here.
  • Copy of the UVM CLICK SmartForm (1 hard copy and 1 on the Commons)
  • Protocol (1 hard copy and 1 on the Commons)
  • Consent Form (1 hard copy and 1 on the Commons)
  • Supporting documents for the protocol (for example: Surveys, Study Diary for the patient) (1 hard copy and 1 on the Commons
  • Investigator Brochure for the study drug (if applicable) (1 hard copy and 1 on the Commons) 

Amendments

Please submit all amendments to the PRMC Coordinator. Amendments involving scientific changes will be reviewed at the monthly PRMC Full Committee meeting. Amendments that do not require PRMC review will be filed and the research coordinator will receive an acknowledgement email from the PRMC Coordinator.

The following documents are required for amendment submissions: 

  • Cover letter with rationale for  amendment changess (1 hard copy or by email)
  • Amendment cover form (1 hard copy or by email)
  • Tracked changes consent and/or protocol (1 hard copy or by email)
  • Clean consent and/or protocol (1 hard copy or by email)
  • Revised Investigator Drug Brochure (if applicable) (1 hard copy or by email)

Other Reporting

Safety reports, quarterly reports, and study closures must be submitted to the PRMC as per the Submission Requirements Main Page

Contact the PRMC Coordinator

Karen Wilson

Phone: (802) 656-4414 ext.2