CORE--PROTOCOL REVIEW AND MONITORING SYSTEM

Oregon Health And Science University, Portland OR

Investigators

Linked publications, trials & patents

Abstract

Description: The system as described appears to contain the critical elements of protocol review. The Clinical Research Review Committee (CRRC) consists of 15 individuals representing multiple oncology disciplines, including medical oncology, hematology, surgery, radiation oncology, community oncology practice, as well as pharmacy, biostatistics, nursing and administration. Review criteria include scientific merit, research design, feasibility of completion, monitoring for accrual, inclusion of women and minorities, toxicity review, and protection of human subjects. There are two subcommittees of the CRRC: the annual review and revision subcommittee and the reportable event subcommittee. Regular interaction with the Biostatistics Shared Resource, the Quality Assurance Program Committee, and the Women and Minorities Task Force impacts on protocol review. Protocol monitoring information is tracked. The procedure defined for scientific review is carefully described, namely any new cancer-related protocol undergoes review by the CRRC program coordinator for administrative review of format, budget, conflicting studies and completeness. Subsequently, there is review by pharmacy, biostatistics, and data management teams for appropriateness and feasibility. After the protocol is reviewed at these levels, the protocol is submitted to two primary reviewers, who provide written reviews, and lead discussion at the committee meeting.