NCTN* and Other Peer-Reviewed Trials

Studies that are sponsored by the NCTN and involve an intervention for the patient must be vetted by a TDT and then reviewed by the PRMC. Please submit the following.

Initial Protocol Submission 

For peer-reviewed trials not eligible for NCI Central IRB (CIRB) review, the following need to be submitted to the PRMC:

  • 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 Drug Brochure for the study drug (if applicable) (1 hard copy and 1 on the Commons)

*Initial Protocol Submission (eligible for CIRB)

If your protocol is eligible for NCI Central IRB (CIRB) review, then the following need to be submitted to the PRMC.

  • UVMCC Clinical Research Protocol Submission Form (1 hard copy and 1 on the Commons)
  • CIRB Common Protocol Cover Form (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 if applicable (for example:
    Surveys, Study Diary for the patient) (1 hard copy and 1 on the
    Commons)
  • Investigator Drug Brochure for the study drug (if applicable) (1 hard copy and 1 on the Commons)

Amendments

Amendments for NCTN studies do not require PRMC review. 

Other Reporting

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

Questions?

Contact the PRMC Coordinator

Karen Wilson

Phone: (802) 656-4414 ext.2