CORE--PROTOCOL REVIEW AND MONITORING SYSTEM

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Description: The Protocol Review and Monitoring System is managed by Dr. Geoffrey Weiss, Chairman, and Ms. Yolanda Medina, protocol specialist. The PRMS is also composed of 14 individuals who are representatives from the major oncologic treatment disciplines (medical, radiation, surgical, urologic and pediatric oncology), biostatistics, and representatives from support disciplines (nursing and pharmacy). Additional members are called upon ad hoc for particular expertise. Membership on the PRMS is rotated with the membership duration being at least three years. Five clinical facilities are affiliated With SACI (CTRC, University Hospital, VA Hospital, St. Luke's Baptist Hospital).All protocols conducted in the affiliates must receive approval through the IRB of UTHSCSA, and requirements of clinical affiliation with SACI include recognition of the authority of the PRMS and prohibition of the conduct at the affiliated instructions of cancer-related clinical protocols that have not been approved by the PRMS. PRMS reviews and stipulations are submitted to the Director of the research committee of each affiliated institution. All protocols must have the signature of the Chair of the clinical department of the Medical Schools whose member is Principal Investigator. The Chair signature endorses the requirement that the investigator mut submit the protocol to PRMS review. Cooperative group protocols are given expedited PRMS review while all other cancer-related clinical research protocols must submit to the full detailed scientific review of the PRMS. Protocols submitted for review are cancer-related therapeutic research studies that are conducted at any affiliate or seek access to SACI-shared resources. Protocols defined for submission are determined by the PRMS office based on the Principal Investigator having been identified by voluntary submission, monthly review of IRB computer files, review of cooperative mailings, a telephone call to the cooperative group member institution office, or by calls to the established protocol office coordinators for the major oncologic disciplines of the SACI-affiliated institutions. PRMS meets monthly and the goal is that PRMS review will occur prior to full IRB approval such that PRMS review will be available in time for revisions to be submitted at the time of IRB full review. The IRB review utilizes PRMS review findings in its deliberations and PRMS reviews are often pivotal in influencing IRB decisions. At the time of PRMS review, each protocol is assigned a primary and secondary reviewer and is reviewed for scientific rationale, appropriate study design, patient accrual estimate, biostatistical rationale and an estimate of the time to completion. Protocols reviewed may either be fully approved, approved following satisfactory response to stipulations, tabled or unconditionally rejected. When the protocol is approved, a schedule is set for review by the committee on protocol accrual. Investigators must submit an annual report an a final report within three months of study conclusion summarizing progress of the study. Investigators are also required to submit demographic information on protocol entries. The PRMS is empowered to terminate protocols in the event that the investigator fails to adequately comply with committee requirements, failure to satisfactorily comply with guidelines for appropriate use of shared resource or achievement of accrual goals. The PRMS sets comprehensive institutional prioritization of all protocols and requests clarification of conflicts. The PRMS has established a prioritization scheme for protocol activation and access to shared resources that places institutional investigator-initiated protocols as first priority with cooperative group studies and pharmaceutical sponsored studies, second and third, respectively.