Lab-based, Specimen collection, or Survey-designed Studies

IRB submission requirements (PDF)

There are some cases where the IRB will allow an exemption of a review. However, the protocol will still need to be reviewed by the Protocol Review and Monitoring Committee for scientific integrity. Please submit all cancer-related protocols to the University of Vermont Cancer Center Protocol Review and Monitoring Committee even if the IRB deems the protocol exempt from IRB review. If you have questions, please email prmc@med.uvm.edu.

Submitting protocols and supporting forms to the PRMC is now available as electronic submission through the UVM Commons. The link to the PRMC page on the Commons is: https://commons.med.uvm.edu/cp/uvmcc/prmc/default.aspx . Not all research coordinators or PIs currently have access to the Commons.  Please contact prmc@med.uvm.edu regarding using the Commons to submit protocols electronically.

Additionally, one paper copy of the protocol and forms must be emailed to prmc@med.uvm.edu.

Initial Protocol Submission

Amendments

Changes to existing protocols, called amendments, are reviewed by the Protocol Review and Monitoring Committee to ensure that the protocol still has scientific validity. Documents may be emailed prmc@med.uvm.edu.

The following documents are required for PRMC review of amendments to existing lab-based or survey-designed  protocols:

  • Cover letter with rationale for  amendment changess (1 hard copy or by email)
  • Amendment cover form (1 hard copy or by email)
  • Revised Investigator Drug Brochure (if applicable) (1 hard copy or by email)
  • "Clean" or final copy of protocol with revisions incorporated (1 hard-copy or by email)

Study Progress Reports

As part of the University of Vermont Cancer Center's data monitoring process, all cancer protocols must submit Study Progress Reports semi-annually to the University of Vermont Cancer Center. The PRMC monitors study progress of all cancer protocols to ensure proper resources are being distributed.