Industry Sponsored Trials
Research studies that are industry sponsored and involve an intervention for the patient must be vetted by the appropriate TDT and then reviewed by the PRMC Full Committee.
Initial Study Submission
- UVMCC Clinical Research Protocol Submission Form The PI is responsible
for completing the PSF in full. Submissions will be returned to the PI if the form is not completed in full and signed by the PI.
- UVMCC Transdisciplinary Team (TDT) New Protocol Review Form The PI must present the
proposed clinical trial to the TDT of the study site. This form must be completed in full by the TDT leader or their designee and may be signed by the TDT leader or their designee. TDT meetings are listed here.
- The current version of the protocol, investigator brochure (if available), pharmacy manual (if available) and laboratory manual (if available)
- All supporting documents for the protocol (for example: Questionnaires, Surveys, etc.)
Please submit the above documents to the PRMC via e-mail to PRMC@med.uvm.edu.
Submission of Study Amendments
Please submit all amendments to the PRMC Coordinator via e-mail to PRMC@med.uvm.edu.
Amendments involving scientific changes will be reviewed at the monthly PRMC Full Committee meeting. Amendments that do not require PRMC review will be acknowledged and filed. An acknowledgement memo will be sent to the regulatory or research
coordinator, PI, and IRB, if applicable.
Amendment submissions must include:
- Cover letter with rationale for amendment changes.
- Revised Protocol, if applicable
- Revised IB, If applicable
UVMCC Amendment – Transdisciplinary Team (TDT) Review Form, If applicable
Study closures to accrual and permanent closures must be submitted to the PRMC as per the Submission Requirements Main Page.