Protocol Review and Monitoring System

Abstract Protocol Review and Monitoring System The City of Hope Comprehensive Cancer Center (COHCCC) Protocol Review and Monitoring System (PRMS) has developed a two-stage review system for the review, oversight and support of cancer research conducted by its investigators. This review system includes a first stage review by (1) Multidisciplinary Disease and Modality Teams (DT/MT) for concept review and endorsements; followed by a second stage review by (2) the Protocol Review and Monitoring Committees (PRMC) which include the Cancer Protocol Review & Monitoring Committee (CPRMC) and the Biospecimen and Data Review Committee (BDRC). The offices that administratively support the DT/MT and the PRMC are within the Clinical Trials Office (CTO) and Clinical Research Protections (CRP) Office, respectively. During its first and second stage reviews, the PRMS is focused on the scientific merit of protocols, prioritization and feasibility of trial completions, as well as the oversight of the progress of approved research and termination of any research that no longer meets those criteria. All proposed cancer clinical research must initially be endorsed by a multi-disciplinary DT/MT and reviewed and approved by the PRMC and reviewed by the PRMC for scientific progress on at least an annual basis. The PRMC has the authority to close trials that do not demonstrate scientific progress and appeals are evaluated by the Committee. The BDRC was launched in April 2021 to support an enterprise-wide, efficient, and centralized scientific, prioritization, and feasibility review process for research involving only the use of tissue and/or data. The BDRC follows the same review processes as the CPRMC and first stage review is required. The PRMS received full approval from the National Cancer Institute (NCI) in 2017.