Notice on the publication of Technical Guidance for Clinical Trial Data Management
Clinical trial data are the most important evidence to support drug licensing. Well-regulated data management is the key to ensure the quality of clinical trials. China's Provisions for Drug Registration and Good Clinical Practice (GCP), and other relevant regulations all have corresponding principle requirements to this. Corresponding detailed technical guidance is also needed in the technical operation level.
In order to strengthen the standardized management of clinical trial data in China, ensure the quality of clinical data of drug research and make the evaluation of drugs based on scientific evidence, our Center has drafted the Technical Guidance for Clinical Trial Data Management since 2009 by referring the relevant international norms and technical guidelines and combining the current clinical trial data management reality, and the final draft has been formed through repeated discussion on expert meetings. Hope insiders can put forward your feedback and suggestions to facilitate the Center to complete further improvement work.
The Center for Drug Evaluation will further detail and formulate the specific technical requirements on data quality assessment and data submission in clinical trial declaration materials. All research and development units, drug clinical trial institutions, clinical trial relevant personnel and related parties please pay close attention to that!
Technical Guidance Feedback Contact: Wang Jun
Tel: +86-10-68585566-475
E-mail: wangj@cde.org.cn.
Information Source: Center for Drug Evaluation of China National Food and Drug Administration