NCTN and Other Peer-Reviewed Trials

Studies that are sponsored by the National Clinical Trials Network (NCTN) and other peer-reviewed trials which involve an intervention for the patient must be vetted by the study disease site Transdisciplinary Team (TDT) and then reviewed by the PRMC. Please submit the following via e-mail to the PRMC coordinator via e-mail at PRMC@med.uvm.edu.

Initial Study Submission 

Peer-reviewed trials that are not eligible for NCI Central IRB (CIRB) review, the following must be submitted to the PRMC:

  • UVMCC Clinical Research 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.) 

 

Study Protocol Amendments

Please submit all amendments to the PRMC Coordinator via e-mail to PRMC@med.uvm.edu.
Amendments for NCTN studies, (regardless of whether they use CIRB or not) do require PRMC assessment for determination of review.  Should the PRMC determine no review is required, a memo will be issued to the PI confirming receipt of the amendment and with no further action required.  The amendment and memo will be maintained on file with the PRMC.

Other Reporting

Study updates, accrual reviews, and study closures must be submitted to the PRMC as per the PRMC Submission Requirements Main Page.