From 28 to 29, August,2021 Advanced Training Course on Clinical Trial Quality in Northwest China, hosted by GCP Group of Northwest Clinical Institution of Professional Committee of Clinical Research Quality and Evaluation of China Quality Association for Pharmaceuticals and Professional Committee of Clinical Research Statistics of World Federation of Chinese Medicine Societies, organized by the First Affiliated Hospital of Xi 'an Jiaotong University (XJTU), was held online. A total of 631 GCP practitioners including researchers, research nurses, administrators, CRC, sponsors, CRO and other staff related to clinical trials from multiple drug clinical trial institutions across China participated in the training course. The total online hits reached 22,700. The opening ceremony was presided over by Lu Mingying, Director of Office of Clinical Pharmacological Institution of our hospital.President Lyu Yi introduced that our hospital is sparing no effort to promote the construction of national medical center and regional medical center. Shan Guangliang, Director of Professional Committee of Clinical Research Quality and Evaluation of China Quality Association for Pharmaceuticals illustrated the main work of the professional committee and the significance of clinical trial quality. Dang Michan, Director of Drug Registration Management Office of Shaanxi Medical Products Administration introduced the general situation and development requirements of clinical trial institutions in Shaanxi province.

Ten experienced experts in the field of clinical trials gave intriguing lectures. Dang Michan, explicitly explained the regulatory requirements of Shaanxi Medical Products Administration and the problems found in daily supervision and inspection under the new laws and regulations. Director Li Ning from Cancer Hospital of Chinese Academy of Medical Sciences delivered an intriguing presentation entitled "Development and Prospects of Research-oriented Ward Construction". Professor Sun Ruihua from China-Japan Friendship Hospital shared the statistical thinking and consideration in clinical research design. Director Yuan Wei'an from Shanghai Shuguang Hospital discussed how to transform the roles of physicians and researchers in new drug clinical trials. Other experts delivered lectures on thinking of the ethics committee work under the new situation, 32 steps and precautions for the implementation of clinical research, research strategies for early-stage clinical trials of innovative drugs, risk control of clinical trials of medical devices, exploration of informatization construction and supervision mode of clinical trial institutions, and design and application of real-world research, respectively.

In the session of "Expert Dialogue", Director Cao Yu, an administrator of clinical trial institution, Professor Ren Jie, a senior researcher, Director Cui Dongyang and Director Xu Zhongnan as representatives of the sponsors, and other experts delivered a panel discussion on "How to transform and develop for the institutions and researchers under the filing system".

The training course centers on both theoretical and practical contents, covering the whole process of clinical trials. It sets up a exchange and mutual learning platform for relevant staff in the field of clinical trials in Northwest China, aiming to jointly improve the clinical research level in this region.