In recent years, clinical trials have become the primary means of evidence-based medicine and an indispensable approach in the research and development of new drugs and medical devices. As clinical trials have expanded across China, the demand for biostatistics has grown steadily, making the advancement of this field a prominent highlight in the pharmaceutical industry and driving robust momentum in its development. To further promote the development of biostatistics in clinical trials in China, strengthen the standardized application of biostatistical methods in clinical research, and effectively enhance the quality and rigor of clinical trial data management and statistical analysis, the Statistical Theory and Methods Professional Committee of the Chinese Society for Health Information and Nanjing General Hospital of the Nanjing Military Region plan to continue hosting the fifth “Training Course on Clinical Trial Data Management and Statistical Analysis” [National Continuing Medical Education Project No.: 2014-12-05-032 (National)]. Details are hereby announced as follows.

　　Suitable for

　　(1) Professionals engaged in clinical trial data management and/or statistical analysis, graduate students, clinical monitors, and others from pharmaceutical universities, research institutions specializing in medical devices and biologics, clinical trial sites, pharmaceutical and medical device companies, and contract research organizations (CROs).

　　(2) Clinical researchers who aspire to conduct high-quality clinical studies and publish high-impact-factor papers, particularly those indexed in SCI, can provide scientifically rigorous methodological guidance and quality assurance for their clinical research.

　　Time and place

　　(1) Date: October 18–20, 2014 (registration on the 17th).

　　(2) Venue: Dongyuanxuan Grand Hotel, Nanjing, Jiangsu Province (at the intersection of Minggong Palace Road and Zhujiang Road; see the attached transportation map).

　　Course Outline and Instructors

　　This training course focuses on the fundamental statistical principles and methods relevant to clinical trials, aiming to provide practical standards and hands-on guidance for clinical trial data management and statistical analysis. The content is closely aligned with real-world needs, ensuring that participants gain valuable knowledge they can immediately apply in their work. We also hope this program will serve as a platform for professional and academic exchange, fostering channels for communication, consultation, and collaboration with industry experts. All instructors are either drug review consultants accredited by the National Medical Products Administration or leading authorities in the field, and they are actively engaged in clinical trial data management and statistical analysis for new drugs, medical devices, and biological products. With many years of frontline experience in these areas, they bring extensive practical expertise. Please refer to the attached schedule and expert profiles for further details.

　　Registration and Related Matters

　　Please submit the registration confirmation form, completed in the attached format, via email by October 10. The total cost of the training course is RMB 1,500, payable upon registration. Accommodation and meals will be arranged centrally; participants are responsible for their own transportation and lodging expenses. Upon successful completion of the assessment, participants will receive a “National-Level Continuing Medical Education Program Credit Certificate” (8 Category I credits).

　　Contact: Lu Mengjie; Contact number: 13611574218; Email: 898545969@qq.com.

　　Postal Code: 210002; Address: Medical Department, Nanjing General Hospital of the Nanjing Military Region, No. 305 Zhongshan East Road, Nanjing, Jiangsu Province.

　　Statistical Theory and Methods Professional Committee of the Chinese Society for Health Information, Medical Affairs Department, Nanjing General Hospital of the Nanjing Military Region

　　August 5, 2014