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中文摘要
翻译
医疗与安全核心 阿尔茨海默病合作研究(ADCS)的医疗和安全核心服务于:为整个项目提供监督和指导,协调各现场和项目总监的活动,并做出涉及政策、优先级和工作流程以及资源和人员分配的决策,为ADCS的运行提供财务控制,协调新协议的制定和实施,监督各委员会的工作,维护与研究中心和供应商的分包合同,制定和实施招聘策略,并与行业、媒体和NIA保持联系。Medical & Safety Core还对医疗不良事件进行编码,使用标准分类和命名方案对ADCS试验中使用的伴随药物进行分类,并向数据和安全监测委员会提供临床试验安全性报告。
英文摘要
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.
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HABS-HD - Core F - Biostatistics Core
Statistics and Data Management
Statistics and Data Management
Statistics and Data Management