MED & SAFETY CORE

医学教育

• 批准号: 8461376
• 负责人: Rema Raman
• 金额: $ 115.98万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8461376
• 关键词: Adverse event; Alzheimer' s Disease; Annual Reports; Biometry; Blinded; Certification; Classification; Clinical; Clinical Trials; Clinical Trials Data Monitoring Committees; Code; Data; Data Reporting; Decision Making; Development; Ensure; Futility; Human Resources; Industry; Institutional Review Boards; Medical; Monitor; Nomenclature; Pharmaceutical Preparations; Physicians; Policies; Process; Protocols documentation; Reporting; Resource Allocation; Safety; Scheme; Serious Adverse Event; Site; Specific qualifier value; Supervision; System; TimeLine; Training; Vendor; Work; cooperative study; data management; design; experience; operation; patient safety; performance site; response; safety study

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.

医疗与安全核心 阿尔茨海默病合作研究的医疗和安全核心(ADCS)的作用是：为整个项目提供监督和指导，协调地点和项目主任之间的活动，做出涉及政策、优先事项、工作流程以及资源和人员分配的决定，为ADCS的运作提供财务控制，协调新方案的制定和实施，监督各委员会的工作，维护与地点和供应商的分包合同，制定和实施招聘战略，并保持与行业、媒体和NIA的联系。医疗与安全核心还对医疗不良事件进行编码，根据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，并向数据和安全监督委员会提供临床试验安全性报告。