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Protocol Review Committee

UMCCTS Protocol Review Committee (PRC)

The UMCCTS Protocol Review Committee (PRC) provides a process for investigators to access expertise critical to the design, implementation, and reporting of high quality clinical trials.  A separate Cancer Center Protocol Review Committee reviews all oncology protocols. The UMCCTS PRC reviews greater-than-minimal risk investigator-initiated clinical trials that have not undergone external peer review. Investigators are asked to submit their studies to the PRC for review prior to submitting to the IRB or Conflict of Interest (COI) Committee review.

PRC members represent a broad range of scientific expertise and include faculty and staff from the UMCCTS Biostatistics Epidemiology & Research Design (BERD), Science Participation Research Center (SPRC), Community Engagement, Investigational Pharmacy, and Informatics Core, as well as representatives from the UMMS Human Research Protection Program and the IRB.

Process:

Investigators submit a standardized template, a copy of the protocol or study plan, and the UMCCTS study feasibility checklist, documentation of sufficient available study participants (using Informatics Core cohort identification tools), planned use of UMCCTS cores and services, inclusion of underrepresented participants, and a communication plan, which includes reporting of study results to patients and Clinicaltrials.gov. PRC recommendations must be addressed prior to protocol IRB submission or COI Committee review.

 UMCCTS FeasibilityChecklist

IRB Investigator Study Plan Template

For more information about the process and any questions about the submission materials, contact:

Ann Han

508-856-1960

Ann.Han@umassmed.edu