CMMI Human Subject Research Enhancement Program

CMMI 人类受试者研究增强计划

• 批准号: 6591448
• 负责人: DAVID M GOLDENBERG
• 金额: $ 10万
• 依托单位: CTR FOR MOLECULAR MEDICINE/IMMUNOLOGY
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2004-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6591448
• 关键词: behavioral /social science research tag; clinical research; clinical trials; computer system design /evaluation; data management; education evaluation /planning; health science research support; human rights; information systems; training

With the exponential growth of human subject research and the continuing expansion of new technologies, it is essential that IRBs have on-going training and tools that will enable them to perform their assigned tasks to the highest level of proficiency. A vital component to the continuing review of clinical trials is a strong monitoring program. An integral component for this program is a database that is used to track the progress of each study. In this regard, the specific aims of this application will be the following: l .) The development of a secure networked database that will be used to assist the IRB and clinical monitoring program in tracking the progress of clinical trials sponsored by our institution. Tracking elements will include such items as documentation of informed consent, protocol and investigator brochure amendments, adverse event listing, serious adverse event notifications, monitoring visits, verification and collection of case report forms, submission tracking (i.e., submission of initial and annual reports to IRB, Radiation Safety Committee, FDA, Data Safety Monitoring Committee), training documentation, etc. 2.) Set up of a new application server to host the database. This will become an integral part of receiving information from CMMI clinical trials within this institution and among affiliated institutions through the use of virtual private networks (VPN). 3.) Provide travel expenses and educational materials for IRB members, investigators, and Regulatory Affairs Office personnel to attend meetings for educational enhancement.

随着人类课题研究的指数级增长和新技术的不断扩展，IRB 必须拥有持续的培训和工具，使他们能够以最高的熟练程度执行分配的任务。持续审查临床试验的一个重要组成部分是强有力的监测计划。该计划的一个组成部分是一个数据库，用于跟踪每项研究的进展。对此， 该应用程序的具体目标如下： l .) 开发一个安全的网络数据库，该数据库将用于协助 IRB 和临床监测计划跟踪我们机构赞助的临床试验的进展情况。跟踪要素将包括知情同意文件、方案和研究者手册修订、不良事件列表、严重不良事件通知、监测访问、病例报告表的验证和收集、提交跟踪（即向IRB、辐射安全委员会、FDA、数据 安全监察委员会）、培训文件等 2.) 设置新的应用程序服务器来托管数据库。这将成为通过使用虚拟专用网络 (VPN) 在该机构内以及附属机构之间接收 CMMI 临床试验信息的一个组成部分。 3.) 为 IRB 成员、调查人员和监管事务办公室人员提供参加教育强化会议的差旅费和教育材料。