ABSTRACT The primary role of the Protocol Review and Monitoring System-Clinical Research Review Committee (PRMS- CRC) of the Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins is to provide rigorous internal scientific review of all human subjects cancer-related protocols within the institution, in accordance with National Cancer Institute Cancer Center Support Grant Guidelines. The Committee is responsible for reviewing the scientific merit, priorities and progress of the clinical research of the SKCCC. The Committee has the authority to approve protocols for IRB review that meet the scientific merit and priorities of the SKCCC and to close protocols that do not demonstrate adequate scientific progress. The PRMS-CRC is supported by the Clinical Protocol and Data Management Office (CPDM). The primary role of the PRMS-CRC of the SKCCC is to provide scientific review and prioritization of all protocols within the Cancer Center and it has the authority to forward protocols for IRB review and to close protocols that do not demonstrate scientific progress The PRMS performs a two-stage review of study protocols. The PRMS-CRC Pre-Review Subcommittee reviews studies for aspects critical to the study's execution, whereas the PRMS-CRC reviews the scientific aspects of a study. The PRMS is distinct and independent in terms of function and leadership from the CPDM and the Data Safety and Monitoring Committee (DSMC).