Deadlines for submission of interventional trials to the PRC/PRMS are approximately 2 weeks before the scheduled meeting date. Please note that any trials lacking the required documentation for review by EOB on the dates listed above may not be guaranteed on the next meeting agenda.
Required documents include the following:
- A completed PRC/PRMS checklist/program director letter
- A copy of full protocol (unsecured)
- A sponsor and/or UPMC Hillman Cancer Center consent form
- Investigator drug brochure
- All trials must receive sign-off from the Disease Center director and all investigator-initiated trials must be approved by a University of Pittsburgh biostatistician prior to submission to the PRC/PRMS (signature on checklist). The Disease Center co-director should sign when the director is the PI.
- Industry trials also require draft budget, contract, lab manual and study equipment and vendors q.
Send finalized documents, including the Regulatory\WorkingDrive hyperlink, to Brandon Kaukus at kaukusbm@upmc.edu or call 412-623-3376 if you have any questions.
Note: Any studies with Chairman as PI should be sent to the opposite committee for review.