The Protocol Review and Monitoring System (PRMS) of the Indiana University Simon Cancer Center (IUSCC) provides internal oversight of all cancer clinical trials of the IUSCC. The PRMS is the shared responsibility of two committees: 1. The IUSCC Scientific Review Committee (SRC) chaired by Dr. James Croop: The SRC evaluates the scientific merit of all cancer-related clinical trials proposed by Indiana University School of Medicine faculty or faculty of other IU schools who require Cancer Center resources, including patients or tissues, for conduct of a clinical trial. It assures that the disease-oriented groups and the Principal Investigator (PI) have appropriately prioritized the trial relative to the availability of patients and research staff. The SRC is also responsible for the "scoring" of protocols seeking support from the IUSCC "Protocol Specific Research" mechanism. 2. The IUSCC Clinical Trials Monitoring Committee (CTMC) chaired by Dr. Romnee Clark: The primary responsibilities of the CTMC are to assess the adequacy of trial-specific data safety monitoring plans (DMSP's) for each protocol reviewed by the SRC, to review IUSCCsponsored studies for patient safety, to ensure protocol and adverse event report compliance, and to conduct internal audits and quality assurance reviews. In this section we will discuss the function of the Scientific Review Committee. The activities of the Clinical Trials Monitoring Committee will be discussed in the Data and Safety Monitoring section. The Clinical Research Committee (CRC) chaired by Dr. Kathy Miller, Interim Associate Director for Clinical Research, oversees the policies and procedures of the SRC and CTMC, receives monthly reports of the activities of these committees, and arbitrates in the event of disputes. An investigator may request informal consultation from the SRC prior to submission of the proposal. Investigators also may seek assistance from a protocol development coordinator for help with protocol development and SRC submission. There are also a variety of protocol templates available on the Cancer Center intranet. After submission, the SRC reviews the protocol document. At the time of the initial review, the CTMC chair evaluates the adequacy of the protocol-specific DSMP, After review, an investigator may meet with a member of the SRC and/or a Cancer Center biostatistician for further guidance. Once a protocol has been approved by the SRC, it is submitted for Institutional Review Board (IRB) review. The IRB receives a copy of the SRC review. No trial can be submitted to the Indiana University-Purdue University at Indianapolis (IUPUI) IRB without prior review by the SRC. The conduct of activated investigator-initiated protocols is monitored by the CTMC (described in the Data and Safety Monitoring section). In the event of significant toxicity and/or protocol regulatory non-compliance, the CTMC chair notifies both the investigator and the CRC of its findings and recommendations. In addition, the CTMC informs the IRB of its findings and recommendations. The CRC reviews and approves the recommendations. In the event of a serious breach of Good Clinical Practice (GCP), the CRC will notify the Director of the IU Simon Cancer Center, who will take appropriate action. It must be emphasized that it is an absolute requirement of the Schools of Medicine and Nursing, as articulated by Deans Craig Brater and Marion Broome, that all cancer clinical or behavioral trials that either are proposed by IU faculty members or proposed by others and that seek the use of IU Simon Cancer Center patients or resources must be submitted for review by the SRC. These protocols must be reviewed and approved by the SRC prior to IRB submission. The IRB will not review cancer trials until they have been approved by the SRC.

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