Investigator Initiated Protocols
Research study protocols that are written by a local principal investigator (PI) and involve an intervention for the patient must be vetted by the appropriate TDT and then reviewed by the PRMC Full Committee. Investigators are required
to submit a fully formatted protocol written according to ICH GCP Guidelines which describes the background, rationale, objectives, design, methodology, statistical considerations, and references which support the research. The
protocol should contain enough information for the committee to conduct a comprehensive scientific review. The PRMC will not accept an IRB Protocol Summary Template Document. The IRB will accept
the PRMC full protocol document in lieu of their IRB Protocol Summary Template Document to reduce duplication efforts.
Investigators who require assistance with protocol development or who have questions regarding this process can contact the PRMC coordinator at PRMC@med.uvm.edu.
Initial Study Submission
- UVMCC Protocol Submission Form (PSF). 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 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 Protocol 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:
Study closures to accrual and permanent closures must be submitted to the PRMC as per the Submission Requirements Main Page.