Protocol Review and Monitoring System ABSTRACT The City of Hope Comprehensive Cancer Center (COHCCC) has a well-established system for review, oversight, and support of cancer research conducted by its investigators. The system includes review by (1) Multidisciplinary Disease and Modality Teams for City of Hope (COH) investigator initiated concepts; (2) the Cancer Protocol Review and Monitoring Committee (CPRMC); (3) the Data Safety Monitoring Committee (DSMC); and (4) the COH designated Institutional Review Boards. The offices that support these committees are centralized within COH?s Research Protections Unit and respectively include the Protocol Scientific Review and Monitoring Office (PSRMO), the Data and Safety Monitoring Office (DSMO); and the Office for Human Research Subject Protections (OHRSP). The COHCCC Protocol Review and Monitoring System (PRMS) is focused on the scientific merit of protocols, prioritization and feasibility of trial completions, as well as oversight of the progress of approved research and termination of research that no longer meets criteria for ongoing continuation. The PRMS is overseen by the CPRMC, which coordinates with investigators and multidisciplinary Disease and/or Modality Teams. The CPRMC is administratively supported by the PSRMO. All proposed cancer research must be reviewed and approved by the CPRMC either through a convened review process or through expedited administrative scientific review for prioritization, as permitted by the CCSG for peer-reviewed research, and reviewed for scientific progress on at least an annual basis. The CPRMC has authority to close trials that do not demonstrate scientific progress, and all appeals are evaluated by the CPRMC. The PRMS continues under the leadership of Karen Reckamp, MS, MD, who has chaired the CPRMC since 2012. Dr. Reckamp is appointed by and reports directly to the Cancer Center Director. The PSRMO is under the direction of Amanda Hammond, JD, Sr. Director of the Research Protections Unit who reports to Ashley Baker Lee, COH?s Senior Vice President for Research Operations. The PRMS was conditionally approved in 2012 and received full approval in 2014.
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