|Wallace Akerley, M.D., Chair
|Adam Cohen, M.D., Vice-Chair
|Mariah Butterfield, Committee Coordinator
I. Background and Purpose:
The Protocol Review and Monitoring Committee (PRMC) was formed in 1993 to comply with National Cancer Institute guidelines in establishing a scientific review and monitoring system of cancer studies - it is a mechanism for quality assurance. The PRMC membership includes faculty, statisticians, pharmacy, imaging, patient advocate, pathology and other ad hoc reviewers from various disciplines within the Health Sciences.
The PRMC reviews cancer-related protocols for scientific merit and progress, including participant accrual. It also prioritizes cancer protocols that may compete for the same patient population. Its function is complementary to that of the Institutional Review Board, which focuses on the protection of human subjects in research.
If your study is designed to involve cancer patients, it must receive PRMC approval before it can be IRB approved. If your study includes cancer patients by default (as part of a broader patient population) and not by study design, it may not require PRMC review.
II. New Project Submission
- For Investigator-Initiated Studies
Investigator-Initiated projects must be submitted, reviewed, and approved by the PRMC prior to IRB submission.
- For New Multi-site, Industry-Sponsored Trials
Multi-site, industry-sponsored trials can be submitted to the PRMC and IRB simultaneously, although the IRB will not provide final approval until the PRMC has approved the project
- For New National Clinical Trials Network Protocols (NCTN) and Externally Peer Reviewed
Projects under the purview of CTEP or otherwise funded by National Institutes of Health (NIH)- approved sources will undergo an expedited PRMC review. For a full list of funding sources that will qualify for expedited review, click here.
- Committee Deadline
The PRMC meets the 4th Thursday of each month. Applications are due by noon nine (9) days before the meeting.
- Exemption from Full-Board PRMC Review
If your study is a non-therapeutic retrospective study (i.e., chart review or database or tissue review only with no patient contact), it may be exempt from full-board PRMC review. Please submit the new application in ERICA (see below). The study will be administratively reviewed to determine if it is exempt from further review.
- Application Process: To submit a study to the PRMC you must complete the ERICA application
If the study is designed to include cancer patients, mark "Yes" to question 4.2g of the new study application. Once you have submitted the study, the PRMC will be notified that your study needs Committee review.
III. Annual Review of Projects
Protocols must be reviewed annually by the PRMC until final closure. The National Cancer Institute mandates regular review of project scientific progress, including accrual reviews. Studies accruing less than 50% of the annual target accrual are carefully evaluated and subject to possible closure by the Committee.
When the yearly project continuing review has been submitted to the IRB via the ERICA website, a review by the Committee will be generated. The continuing review application will be retrieved from ERICA by PRMC staff for review and the PI and IRB notified if issues are identified.
IV. Protocol Modification/Amendments/Final Project Reports
All study changes to Investigator Initiated Trials must be submitted to and reviewed by PRMC for potential impact on study design or progress. Study changes include amendments, amendments within continuing reviews(see Section III above), and final project reports.
All relevant information from these applications will be retrieved from ERICA and reviewed by the PRMC. The PI and IRB will be notified if the Committee identifies issues that need to be addressed.
Contact the PRMC Committee Coordinator, email@example.com
Note: The Protocol Review and Monitoring Committee was called the Clinical Cancer Investigations Committee (CCIC) prior to April 2015.