PROJECT SUMMARY ? PROTOCOL REVIEW AND MONITORING SYSTEM Overview The Protocol Review and Monitoring System (PRMS), referred to at Stanford as the Scientific Review Committee (SRC), has been operational at Stanford University since 2005. Each year we have reviewed our operations and implemented improvements in order to ensure that studies conducted at the Stanford Cancer Institute (SCI) are of the highest scientific merit, feasible to conduct and employ resources appropriately. SCI's SRC is charged with providing peer review of all institutional and national clinical research protocols involving cancer patients at Stanford. The patient and other populations from which SCI studies are drawn include those in the Stanford Clinical Cancer Center, Stanford Health Care at large including outreach sites, Stanford Children's Health and the Cancer Prevention Institute of California. Scientific review applies to all phases of clinical therapeutic intervention, behavioral clinical trials, tissue and body fluid research, and diagnostic trials that impact medical decision making for the treatment of cancer patients. Particular attention is paid to reviewing investigator-initiated clinical trials, and especially those for which there is no other peer-review mechanism. The primary focus of scientific review is on the scientific merit of the study. However, the SRC is also responsible for ensuring that studies conform to the research objectives and priorities of SCI. Scientific review is performed in addition to the review of ethical issues carried out by Stanford's Administrative Panels on Human Subjects in Medical Research, also called Institutional Review Boards (IRBs). Both the SRC and the IRB must approve any study prior to subject enrollment. SCI ensures that its clinical research studies are of true scientific merit, high quality, have access to an adequate patient population and meet requisite statistical benchmarks. To accomplish these objectives, the SRC is charged with providing scientific peer review of all research protocols involving cancer patients treated at SCI. The SRC also has the authority to review and approve or deny all trials involving subjects with cancer. The SRC is also responsible for annual reviews of studies and has the authority to suspend or close studies due to low accrual, stopping rule violations, change in scientific relevance or other scientifically-based reason.