Lab-based, Specimen collection, or Survey-designed Studies
Lab-based, specimen collection or survey-studies that are studying one or more specific disease groups must be vetted by the study disease site Transdisciplinary Teams (TDT) for each group and then reviewed by the PRMC Committee.
While the IRB does allow exemptions to these types of studies, these types of study are NOT exempt from PRMC review and submission and subsequent approval of these studies by the UVMCC PRMC is required.
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.)
Study Protocol Amendments
Please submit all amendments to the PRMC Coordinator via e-mail to PRMC@med.uvm.edu.
All amendments will be assessed for level of PRMC review. Amendments involving scientific changes will be reviewed at the monthly PRMC Full Committee meeting. The Principal Investigator and research coordinator will receive an acknowledgement of amendments that do not require PRMC review, and the amendment will be kept on file with the PRMC.
The following documents are required for amendment submissions:
- Amendment summary or cover letter with rationale for amendment changes
- Tracked changes version of the revised protocol
- Clean version of the revised protocol
Study updates, accrual reviews, and study closures must be submitted to the PRMC as per the PRMC Submission Requirements main page.