Journal of Bioequivalence & Bioavailability

Quality assurance system for Chinese clinical studies of Chinese clinical trials registry

International Conference and Exhibiton on Pharmaceutical Regulatory Affairs

6-7 September 2011 Baltimore, USA

Taixiang Wu

Scientific Tracks Abstracts: JBB

Abstract:

A s a national public clinical trial registry and a recognized Primary Registry of WHO, Chinese Clinical Trial Registry (ChiCTR) takes the respon sibility to dissimilate the knowledge of clinical trial transparency which is an import ant ethics issue of medical studies involving human, and to promote the quality of medical studies in China. Th e ChiCTR had developed three key points to ensure the quality of clinical studies include: 1. Register a clinical study involving human before recruiting the fi rst participants; 2. Real-time monitoring system: eCRF public system; 3. Good reporting the results. We have developed ideas: 1. to register clinical studies is the ethics responsibility and obligation of trialists but not for the purpose of publication; 2. a clinical study is a public event itself which needs public population to participate, and the results may be used to public population service. Th erefore, public have the right to know how the study is processing

Biography :

Taixiang Wu is the administrator of Chinese Clinical Trials Registry, a primary registry of WHO, a pioneer of clinical trial transparence in China. He has published more than 130 papers in reputed journals and serving as an editorial board member and peer reviewer of repute.