CORE--CLINICAL TRIAL PROTOCOL REVIEW AND MONITORING SYSTEM

$72,259P30FY2002CANIH

Mayo Clinic Coll Of Medicine, Rochester, Rochester MN

Investigators

Linked publications & trials

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Abstract

Description: The protocol review process involves the active participation of six separate committees: 1) The Executive Committee meets monthly and has programmatic oversight of clinical studies; 2) The Cancer Center Clinical Research Committee consists of 15 senior members and reviews all concepts proposed for clinical studies. This committee must approve all concepts before further development can occur; 3) The Protocol Review Committee (PRC), which has evolved into two subcommittees (Hematology and Cancer Center Protocol Review) that provide the majority of the PRMS review process; 4) The Administrative Committee meets weekly and reviews all adverse drug reactions (ADRs), protocol amendments, and NCI directives. Every protocol-related problem from the preceding week is reviewed. All protocol violations are reviewed and discussed in this forum; 5) The Resource Utilization Committee meets quarterly to review resource utilization; and 6) The Tumor Study Groups, which are mutidisciplinary disease-focused groups that are responsible for the development of clinical trials. The Group Chair is responsible for the development of activities and approval of research projects. This group develops the study concepts.

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