The Protocol Review and Monitoring Committee (PRMC) is a multidisciplinary committee responsible for peer review of all clinical research protocols at the Samuel Oschin Comprehensive Cancer Institute (SOCCI). The PRMC’s objectives are:
- to foster development of SOCCI clinical research protocols
- to assure through peer review scientific quality, feasibility, timeliness and ethics
- to assign priorities in the use of SOCCI resources to support clinical research, and
- to monitor the progress of ongoing research studies
Establishment of research goals and scientific priorities begins at the Department or Division level or within each clinical or translational research program. The initial PRMC review will assess whether the protocol meets standards of scientific design, including scientific rationale, specific objectives, endpoints, biostatistical design and analysis, and the ability to accrue patients and meet endpoints. The PRMC will assess whether the data to be collected are appropriate to the study’s goals, and will review important issues of social justice such as the inclusion of women and minorities.
The PRMC has the authority to:
1) Approve or disapprove the submission of protocols to the Institutional Review Board (IRB)
2) Require modifications in any aspect of a study protocol prior to IRB submission
3) Require supplemental supporting background information before completing its’ review of a protocol
4) Monitor trial activity and if deemed appropriate request that the Principal Investigator close poorly performing studies.
The function of the PRMC is distinct from that of the IRB whose focus is on human subjects’ protection. Both PRMC and IRB approval are required, in that order, for a protocol to go forward. The objectives of the PRMC are consistent with, and derived from, the National Cancer Institute (NCI) guidelines for Comprehensive Cancer Center Grant (CCSG) designation.