Purpose and Responsibilities
The Protocol Review and Monitoring Committee’s (PRMC) purpose is to scientifically review all human subject cancer or cancer-related protocols and establish their relative priority to the institutional mission. In addition, the PRMC is responsible for reviewing the appropriateness of Data and Safety Monitoring plans, monitoring accrual and patient safety for all cancer or cancer-related studies within the institution.
It will be the responsibility of the PRMC to:
- Review the scientific merit, accrual goals, ethical appropriateness, statistical analysis, appropriateness of trial design and progress of all KUMC cancer or cancer-related protocols
- Encourage and promote advancements and collaboration of revolutionary, ground-breaking, and scientifically excellent cancer or cancer-related studies that focus on prevention, early detection, diagnosis, and treatment.
- Prioritize competing studies and resources based upon the KUCC institutional prioritization plan.
- Monitor protocol accrual and adverse events – develop policy and procedures relating to accrual rates and discontinuation and/or recommendations to the PI
- Receive reports/updates from the Human Subjects Committee and the Data and Safety Monitoring Board and take appropriate steps to ensure data integrity and subject safety of all KUMC clinical trials
- Establish guidelines for determining level of monitoring for each class of protocol
- Provide streamlined process for the submission, review and ethical review of all cancer or cancer-related protocols.
- Recommend to the KUCC Director or their designee, the closure of any cancer or cancer-related research that does not meet adequate safety standards, scientific merit and/or accrual goals.
- The Director of the KUCC or their designee retains the ability and authority to close any cancer or cancer-related research based on the recommendations of the PRMC, HSC or the DSMB.
Apr 30, 2014