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PROTOCOL REVIEW AND MONITORING SYSTEM

$154,663P30FY2017CANIH

Case Western Reserve University, Cleveland OH

Investigators

Stanton L Gersoncontact

Linked publications, trials & patents

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Abstract

PROJECT SUMMARY (See instructions): The Case CCC Protocol Review and Monitoring System (PRMS) is responsible for scientific evaluation, prioritization, and monitoring of all cancer clinical trials conducted at consortium institutions. The PRMS is independent of and complements the activities of the Institutional Review Boards (IRBs) and Data Safety and Toxicity Committee (DSTC). The Case CCC PRMS is operationalized through the Protocol Review and Monitoring Committee (PRMC). The PRMC resides within the Case CCC Clinical Research Office, which oversees and coordinates the activities of the Clinical Trials Core Facility (CTCF), Protocol Review and Monitoring System, Data and Safety Monitoring, and Protocol Specific Research Support. The PRMC supports the clinical research programs of the Case CCC by providing scientific review (and associated feedback to assist in protocol development), establishing priority ranking for protocols within a given disease category and by monitoring the progress and patient accrual. The PRMC membership is selected to ensure diverse expertise relevant to cancer clinical research and is composed of pharmacists, nurses, clinical investigators, biostatisticians, translational PhD scientists and patient advocates from consortium member institutions. The PRMC operates as a single committee across the consortium and has authority to review all new clinical research protocols, including those sponsored by the Cancer Center, NCI, other NIH, industry, foundations, or other sources. These include therapeutic, behavioral, and observational studies. The PRMC has authority for closure of ongoing studies that are accruing slowly and are unlikely to accomplish their scientific goals, and a structured process for accrual evaluation is followed. New protocols, continuing reviews and amendments are evaluated by the PRMC. In 2011, PRMC reviewed 185 new protocols.

View original record on NIH RePORTER →