MEDICAL &SAFETY CORE The Medical &Safety Core of the Alzheimer Disease Cooperative Study (ADCS) serves to: provide supervision and direction for the project as a whole, coordinate the activities of the sites and the Project Directors with each other and make decisions involving policy, priority and flow of work as well as allocation of resources and personnel, provide fiscal control for the operation of the ADCS, coordinate the development and implementation of new protocols, oversee the work of the various committees, maintain subcontracts with sites and vendors, develop and implement recruitment strategies, and maintain contact with industry, the media and NIA. The Medical &Safety Core also codes medical adverse events, classifies concomitant medications used in ADCS trials with standard classification and nomenclature schemes, and provides clinical trial safety reports to the Data and Safety Monitoring Board.
Medical and Safety Core: The Administrative and Medical Cores work closely together to generate safety reports for distribution to participating sites for submission to their respective IRBs and to provide safety data summaries to the Project Directors to assist them in preparing the annual report for each trial. The two cores together also provide guidance to the Project Directors with respect to the content, coding, format, and timelines for reporting serious adverse events to the FDA and participating IRBs.
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