Protocol Review and Monitoring System (PRMS). HCI requires that all cancer clinical trials undergo vigorous scientific review prior to study initiation and throughout the conduct of the trial; that trials arc subject to continuous data and safety monitoring; and that protocols undergo periodic review and audit of research records to ensure scientific integrity. The Clinical Cancer Investigations Committee (CCIC) and an independent Data and Safety Monitoring Committee (DSMC) have been established. These cancer center committees assure the highest level of clinical research scientific review, safety and integrity. The multidisciplinary CCIC reviews all therapeutic, prevention, and behavioral studies performed at HCI for scientific merit, priority, and progress. CCIC review focuses on the scientific quality of the research, the appropriateness of study design as it relates to the research question, the scientific importance of the research question, and the impact the study will have on cancer patients. CCIC members assign a priority score to every approved study. For all cancer center studies, a priority score between 1.0 and 2.99 (inclusive) is required for access to HC[ shared resources. Disapproved studies are not activated and are not approved by the IRB. The DSMC provides a data and safety monitoring function for all HCI clinical trials, except those that require an independent Data and Safety Monitoring Board. The method and level of monitoring depends upon the study phase and the size and complexity of the clinical trial and is commensurate with the degree of risk for study participants. Two subconmlittees of the DSMC have been established to monitor study and data integrity: the Data Quality (audit) Subcommittee (DQS) and the Endpoint Review Subcommittee (ERS). The DSMC is empowered to suspend a protocol immediately for substantial concerns about patient safety or data quality.
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