The Protocol Review and Monitoring System (PRMS) of the Indiana University Simon CancerCenter (IUSCC) provides internal oversight of all cancer clinical trials of the IUSCC. The PRMS isthe shared responsibility of two committees:1. The IUSCC Scientific Review Committee (SRC) chaired by Dr. James Croop: The SRCevaluates the scientific merit of all cancer-related clinical trials proposed by Indiana UniversitySchool of Medicine faculty or faculty of other IU schools who require Cancer Centerresources, including patients or tissues, for conduct of a clinical trial. It assures that thedisease-oriented groups and the Principal Investigator (PI) have appropriately prioritized thetrial relative to the availability of patients and research staff. The SRC is also responsible forthe '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: Theprimary responsibilities of the CTMC are to assess the adequacy of trial-specific data safetymonitoring plans (DMSP's) for each protocol reviewed by the SRC, to review IUSCCsponsoredstudies 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 theClinical 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 forClinical Research, oversees the policies and procedures of the SRC and CTMC, receives monthlyreports 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 withprotocol development and SRC submission. There are also a variety of protocol templatesavailable 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-specificDSMP, After review, an investigator may meet with a member of the SRC and/or a Cancer Centerbiostatistician for further guidance. Once a protocol has been approved by the SRC, it is submittedfor Institutional Review Board (IRB) review. The IRB receives a copy of the SRC review. No trialcan be submitted to the Indiana University-Purdue University at Indianapolis (IUPUI) IRB withoutprior review by the SRC.The conduct of activated investigator-initiated protocols is monitored by the CTMC (described in theData and Safety Monitoring section). In the event of significant toxicity and/or protocol regulatorynon-compliance, the CTMC chair notifies both the investigator and the CRC of its findings andrecommendations. 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 GoodClinical Practice (GCP), the CRC will notify the Director of the IU Simon Cancer Center, who willtake appropriate action.It must be emphasized that it is an absolute requirement of the Schools of Medicine and Nursing, asarticulated by Deans Craig Brater and Marion Broome, that all cancer clinical or behavioral trialsthat either are proposed by IU faculty members or proposed by others and that seek the use of IUSimon Cancer Center patients or resources must be submitted for review by the SRC. Theseprotocols must be reviewed and approved by the SRC prior to IRB submission. The IRB will notreview cancer trials until they have been approved by the SRC.
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