IGF::OT::IGF: IOM Study on Clinical Trial Data Sharing

IGF::OT::IGF：IOM 临床试验数据共享研究

• 批准号: 8755813
• 负责人: JILL COLLAMORE
• 金额: $ 7万
• 依托单位: NATIONAL ACADEMY OF SCIENCES
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-30 至 2015-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8755813
• 关键词: Address; Clinical Research; Clinical Trials; Data; Disclosure; Ethics; Institute of Medicine (U.S.); Legal; Participant; Patients; Privacy; Provider; Randomized Controlled Clinical Trials; Research; Rights; Study Subject; Type - attribute; adverse outcome; benefit sharing; data exchange; data sharing; risk sharing

An ad hoc committee of the Institute of Medicine will conduct a study to develop guiding principles and a framework for the responsible sharing of clinical trial data. For purposes of the study, the scope will be limited to data gathered under randomized controlled clinical trials, and ¿data sharing¿ will include both unilateral disclosure of data, e.g., by a research sponsor or regulator (data transparency), and exchange of data among more than one organization or sector, whether or not those data are ultimately made public. Specifically, the committee will:

医学研究所的一个特设委员会将开展一项研究，以制定负责任地共享临床试验数据的指导原则和框架。出于研究目的，范围将仅限于随机对照临床试验下收集的数据，“数据共享”将包括单方面披露数据，例如由研究申办者或监管者（数据透明度），以及多个组织或部门之间的数据交换，无论这些数据最终是否公开。具体来说，委员会将：