Protocol Review and Monitoring Systems

Dartmouth College, Hanover NH

Investigators

Linked publications, trials & patents

Abstract

SUMMARY: PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS) The Dartmouth Cancer Center (DCC) PRMS, known internally as the Clinical Cancer Review Committee (CCRC), is responsible for reviewing all cancer-related clinical research at DCC. The objectives of the CCRC are to determine whether a clinical research protocol is scientifically and statistically rigorous and feasible with an appropriate data and safety monitoring plan. The CCRC prioritizes clinical research studies that reflect DCC science and meet the needs of DCC’s rural catchment area. CCRC members are selected by the Chair of the CCRC and approved by the DCC Director to represent the broad spectrum of oncology expertise, which includes expertise in population science. Representatives are included from medical oncology, hematology, radiation oncology, surgical oncology, pediatric oncology, clinical pharmacology, biostatistics, laboratory-based science, population science, clinical research administration, and patient advocacy, among others. Scientific review is conducted through a two-stage process, with the disease-specific Clinical Oncology Groups (COGs) conducting the first-stage review based on scientific merit, feasibility, and priority that includes consideration of competing protocols and role of the DCC investigator. The CCRC reviews protocols only after COG approval and monitors ongoing clinical research studies for progress and safety. A further review is conducted by the Dartmouth Health Institutional Review Board (DH IRB). Until recently, CCRC approval was necessary prior to submission to the DH IRB; however, as of October 2023, this process now occurs in parallel for selected studies to enhance administrative responsiveness. The CCRC ensures that all cancer-related clinical trials at DCC are designed appropriately and meet NIH policy and guideline on the engagement in clinical research of women, minorities, and individuals across the lifespan. The CCRC also monitors ongoing clinical research studies for progress, reviewing investigator-initiated trials based upon level of risk assessment and all other protocols annually. The CCRC has the sole authority to approve, require modifications of, disapprove research activities, and terminate protocols that are not demonstrating appropriate progress or will not meet their scientific objectives. The CCRC functions in an integrated manner, with the DH IRB, the DCC Data and Safety Monitoring Committee, and other DCC entities, to facilitate efficient, equitable and inclusive research at DCC.