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 Center for Clinical and Translational Science (CCTS) offers the Protocol Review Committee (PRC) as a service to investigational teams that meet specific criteria. Those include:

• Study is greater than minimal risk
• investigator initiated
• have not undergone peer review (such as a submission for funding)

Further, the UMass Chan Institutional Review Board may request OR require that protocols be reviewed by the PRC prior to being assigned to an IRB Meeting.

Reviewers on the PRC include faculty and staff with experience in the areas of biostatistics and research design, clinical research, community engagement*, investigational drug services*, informatics*, as well as representatives from the UMass Chan Human Research Protection Program (HRPP). 

*If applicable

Process:

Reviews are conducted on an as needed basis. 

All requests for review must be submitted through TRAcs. 

 All requests should be submitted through TRAcs must include the following documents:

• CCTS Study feasibility checklist
• Study protocol OR Investigator Study Plan (ISP) - DRAFT
• Informed Consent Form (ICF) - DRAFT

Typical review time can be approximately 2 weeks but may vary depending on the complexity of the study and volume of requests.

For more information about the process and any questions about the submission materials, contact:
Ann Han
508-856-1960
Ann.Han@umassmed.edu