The Clinical Trials Protocol Review and Monitoring Committee (CTPRMC) is entrusted with the responsibility of providing oversight for the scientific merit and safety monitoring of clinical trials carried out at the Chao Family Comprehensive Cancer Center. The membership consists of Cancer Center members from diverse fields, chosen to span the clinical fields necessary for complete review of institutional trials and reflects the expertise required for the scientific review of investigator initiated and pharmaceutical company sponsored trials. Currently, all investigator initiated protocols and industry sponsored trials involving patients cared for at UCICCC must undergo review by the CTPRMC prior to Institutional Review Board (IRB) review. Cooperative group trials are exempt from initial review by the CTPRMC committee based on their already having passed through peer review by both the cooperative groups and CTEP. However, as part of the safety monitoring requirements for all clinical trials carried out at UCICCC, the CTPRMC performs a safety audit of all trials, including cooperative group studies. The CTPRMC meets twice monthly (alternating full committee and subcommittee), to review the essential protocol elements, including clear rationale, appropriate and efficient study design, biostatistical input, attainable, accrual, and feasibility for completion within a reasonable time frame.
Showing the most recent 10 out of 1106 publications
