Accelerated Approval
Studies can be eligible for Acclerated Review in cases where there is an immediate need for a patient to enroll onto a study. In those cases, the turn-around time from submission to PRMC approval is ideally within five work days. The PRMC Chair will perform an accelerated review of a new protocol and give approval if the following conditions are met
- There is an eligible patient who needs treatment before the protocol is scheduled for PRMC review.
- The patient has no other treatment options.
- The patient may benefit from the treatment offered by the protocol.
Protocol Submission
- Written Request/ Justification for Accelerated Approval (1 hard-copy and 1 emailed copy)
- UVMCC Clinical Research Protocol Submission Form (1 hard-copy and 1 emailed copy)
- Copy of the UVM CLICK SmartForm (1 hard-copy and 1 emailed copy)
- Protocol (1 hard-copy and 1 emailed copy)
- Consent Form (1 hard-copy and 1 emailed copy)