北京大学临床研究所
阅读次数： 发布日期：2018-03-21
北京大学临床研究所成立于2008年6月18日，直属北京大学医学部，是国内第一个由大学成立的专门从事临床研究的教学、科研、服务、组织协调和技术支持的公共平台。
研究所致力于为高质量的临床研究提供技术支撑和培养优秀的临床研究专业人才，从而推动我国临床研究的发展，提高临床研究水平，为人类健康的维护和保障做出应有的贡献。
2014年11月，由研究所牵头申请的“临床研究方法学”二级学科获教育部批准设立，并获硕士和博士授权点，本学科为临床医学一级学科下的二级学科。“临床研究方法学”是临床研究的方法论，是一门多学科交叉的科学。
主要研究方向为：
（1） 临床研究的伦理学实践
（2） 临床研究项目开发与设计
（3） 临床研究的数据技术与应用
（4） 临床研究的统计设计与分析
（5） 临床研究项目管理与质量控制
（6） 新药与医疗器械临床研究法规与注册
研究所的职能主要包括提出、设计、组织和实施高质量的重大临床研究项目，并代表医学部，支撑、协调和管理全校范围内的跨院项目和全国性的多中心合作项目；为附属医院及全国相关机构提供临床研究的技术服务和技术推广；构建全国临床研究网络，推动全国临床研究工作；开展国际间的临床研究合作与学术交流。
研究所设有4部1室（即：项目开发与管理部、教育培训部（下设伦理培训中心）、数据管理部、生物统计部和所办公室），形成了一支包括6名教授、10名客座教授、3名副教授、9名博士、18名硕士的业务熟练、配置合理的专业团队，建立起了一整套国际标准化操作规程（SOP），拥有了国际一流的临床研究数据管理系统和国内先进的计算机网络工作平台，已经具备设计、执行、监管和组织协调高质量临床研究项目的能力，并向社会提供高水平的服务。
研究所的数据管理团队得到国际认证，成为能够承接国际高水平项目的临床数据管理机构。研究所先后成为“北京市新药临床研究设计与管理技术服务中心”和“北京市临床研究质量促进中心”。2013年，研究所获教育部批准建设我国第一个“临床研究方法学”二级学科，并成为硕士和博士授权点。
建所以来，研究所已为近百项由国家科技部、北京市科委资助的科技重大专项以及由国际机构和北京大学支持的重大临床研究创新项目提供了技术支持,其中TESTING等项目已产出了影响国际临床指南的创新成果。
机构负责人：方伟岗
联系人：杨佳
邮箱：pucri_yangj@bjmu.edu.cn
电话：82805563转508
地址：学生公寓6号楼
网址链接：http://pucri.bjmu.edu.cn/Default.aspx
Peking University Clinical Research Institute (PUCRI)
Peking University Clinical Research Institute (PUCRI) was established in June 18, 2008, as an affiliation of the Peking University Health Science Center (PUHSC). It is China’s first academic institution devoted to education & training, research, services, management & coordination, technological support, and policy development in clinical research.
The PUCRI is committed to improving human health through advancing clinical research, by producing talents in clinical research and providing technological support that enables quality clinical research.
The PUCRI led the application of the “Clinical Research Methodology” secondary subject, which is approved by the Ministry of Education in November 2014, and PUCRI had the doctorate and master degrees awarding units of the secondary subject.
Major Research Fields：
(1) The Practice of Medical Ethics in Clinical Research
(2) The Project Development and Design in Clinical Research
(3) The Data Technology and Application in Clinical Research
(4) The Statistical Design and Analysis in Clinical Research
(5) The Project Management and Quality Control in Clinical Research
(6) New Drug and Medical Apparatus and Instruments Registration in Clinical Research Laws
The PUCRI has four departments and one office (i.e. the Department of Project Development and Management, the Department of Education and Training, the Department of Data Management, the Department of Biologic Statistics, and the Executive Office.) , holds a professional team with reasonable configuration of 6 professors, 10 visiting professors, 3 associate professors, 9 doctors and 18 masters. Furthermore, the PUCRI formulated a whole set of international standardized operating procedures (SOP), had a world-class clinical research data management system, and established the domestic advanced working platforms of computer network. The PUCRI was capable for the design, development, supervision, and the organization and coordination of the high quality project in clinical research, and provided high standard services for the society.
The main function of PUCRI is:
To design, organize and implement the high quality clinical research projects, and support, coordinate, and manage the clinical research projects between hospitals within the scope of whole school and the national polycentric-cooperative projects.
To provide clinical research service, technical training courses, and technical promotion for the affiliated hospitals and the national related institutions;
To conduct the advanced training and education in clinical research.
To construct a national clinical research network and promote the clinical research work.
To develop international cooperation and academic communication in clinical research.
PUCRI has become “a Technical Service Center of New Drug Clinical Research Design and Management in Beijing” and a “Beijing Clinical Research Quality Promotion Center”.
Since the construction of PUCRI, the institute has provided technical support for nearly 100 national science and technology projects which are supported by The Ministry of Science and Technology and the Beijing Municipal Science and Technology Commission, and the important clinical research innovation projects supported by the international institutions and Peking University. The TESTING project and other clinical research projects had produced International clinical guidelines innovation achievements
Director: Fang Wei-gang
Contact: Yang Jia
E-mail：pucri_yangj@bjmu.edu.cn
Tel：82805563-508