PROTOCOL REVIEW AND MONITORING SYSTEM

Northwestern University At Chicago, Evanston IL

Investigators

Linked publications, trials & patents

Abstract

The Robert H. Lurie Cancer Center (Lurie Cancer Center) has developed a comprehensive system of protocol review and oversight called the Clinical Protocol Scientific Review and Monitoring System (CPSRMS). This system is comprised of three distinct committees that work collaboratively to provide oversight of all aspects of clinical research conducted at the Lurie Cancer Center. These committees include: the Scientific Review Committee (SRC), the Data Monitoring Committee (DMC), and the Clinical Trial Audit Committee (CTAC). Each committee includes a Chair and/or Co-chair, but the CPSRMS overall is directed by the Associate Director for Clinical Investigations ofthe Lurie Cancer Center, Dr. Al B. Benson. This position is appointed by and reports to Dr. Steven Rosen, the Director ofthe Lurie Cancer Center. The three committees work in conjunction to form a robust system designed to ensure that research conducted at our center has scientific merit and meets the goals and priorities of the center, that clinical trial progress is maintained, and that patient safety and data integrity are maintained for our Northwestern University investigator-initiated trials (NU IITs). The CPSRMS committee responsible for Protocol Review and Monitoring (PRMS) is the SRC. The SRC is charged with the responsibility of evaluating all new and ongoing clinical research protocols for scientific merit, institutional priority and ongoing progress. The committee is a multidisciplinary committee that meets bimonthly to evaluate protocols. All cancer-relevant research studies conducted within the Lurie Cancer Center fall under the purview of this committee and require a level of review. Any faculty member within NU and all Lurie Cancer Center members are required to submit cancer-relevant clinical research protocols to the SRC for review. Protocols are classified into four types: institutional, external peer-reviewed, national/cooperative group, and industrial trials. The different types of protocols undergo different levels of review by the SRC. Any study that is reviewed and approved by an NCI approved peer-review committee (national trials and external peer-reviewed) is exempt from initial and ongoing SRC review for scientific merit. These studies are reviewed administratively for prioritization, and are reviewed annually for progress. All other studies (institutional and industrial) require initial and ongoing SRC review for scientific merit, and also are reviewed for prioritization and progress. Importantly, the NU Institutional Review Board (IRB) requires Lurie Cancer Center endorsement for all cancer-relevant protocols prior to IRB review, therefore ensuring the SRC review requirements have been appropriately met. The administrative support for SRC is coordinated through the Clinical Research Office (CRO).