Studies may be eligible for Accelerated Review in cases when time is of the essence (including requests for emergency use and expanded access), the PRMC Chair can call for an accelerated full committee review. Requests for compassionate use of a study drug will be not reviewed by the PRMC if there is no research data or no data collection is involved. PRMC review will be conducted at the request of the IRB when there is an urgent need for the use of an investigational drug or device outside of a clinical trial and may grant approval if the following conditions are met:
- There is an eligible patient who requires treatment before the study is scheduled for PRMC review.
- The patient has no other treatment options.
- The patient may benefit from the treatment offered by the protocol.
- Written Request/Justification for Accelerated Approval from the treating physician with prior approval from the IRB.
- UVMCC Clinical Research Protocol Submission Form (PSF) completed in full and signed by the Principal Investigator (PI)
- A copy of the full Study Protocol
- Investigator brochure for the study drug (if applicable), Pharmacy Manual (if applicable), and Lab Manual (if applicable)
Review request submission emailed to PRMC@med.uvm.edu