The Clinical Research Committee (CRC) at the Lombardi Comprehensive Cancer Center (Lombardi) is responsible for the review of clinical cancer research protocols for scientific merit, ensures prioritization of protocols based upon scientific priorities and patient availability, and monitors scientific progress of cancer protocols. CRC approval is required for institutional cancer treatment protocols to gain access to Lombardi's CCSG-supported resources. Additionally, since the last submission, the CRC has expanded to include review of all cancer treatment protocols being carried out at all the MedStar Health network hospitals and representatives from these institutions are now members of the CRC. While the focus of the CRC is on institutional protocols, all studies (except for those that do not involve a cancer therapy for a cancer patient population and cooperative group studies with central Institutional Review Board [IRB] approval) are reviewed by the CRC. The CRC is composed of clinical investigators, biostatisticians, a population scientist and several translational researchers. Claudine Isaacs, MD, a member of the CRC, assumed the position of Clinical Co- Chair of the Committee. Together with William Waterfield, MD, the Co-Chair, the chairs direct the administrative functions of the CRC, with the support of an administrative coordinator. Responsibilities of the Co-Chairs include the review of the protocols before, during, and after the monthly CRC meeting (to determine whether modifications to protocols have been appropriately implemented), assignment of appropriate reviewers for each submitted protocol, development of a monthly agenda, completion of meeting minutes, review of assignments, and supervision of the administrative functions required to support the CRC. The function of the CRC is independent of the role of the IRB. The priority of the CRC is to ensure quality in the design and conduct of Lombardi protocols, while the priority of the IRB is to ensure protection of human subjects. The purpose of the IRB is to monitor research involving human subjects, assure compliance with the Food and Drug Administration (FDA) and the Department of Health and Human Services regulations and ensure the protection of the rights and welfare of human subjects. The CRC evaluates the scientific merit of a protocol, ensures prioritization of protocols based on scientific priorities and patient availability, and monitors scientific progress of cancer protocols. The CRC also reviews all consent forms to ensure that they adequately and accurately reflect the science ofthe protocol. As part of the initial scientific review, the CRC also identifies protocols that need institutional data and safety monitoring oversight and specifies study elements to be monitored. Operating in conjunction with the CRC, the Data and Safety Monitoring Committee (DSMC) monitors the elements identified by the CRC.
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