According to the requirements of the Regulations on the Administration of Drug Clinical Trial Institutions issued by the National Medical Products Administration (NMPA) and the National Health Commission, and the Notice of the Center for Certification and Evaluation of Guangdong Drug Administration on the Supervision and Inspection of Drug Clinical Trial Institutions, the inspection team of the Center for Certification and Evaluation of Guangdong Drug Administration visited Shenzhen Samii Medical Center (The Fourth People's Hospital of Shenzhen) (SSMC) on November 29, 2022, to conduct the first inspection of SSMC as a GCP institution on record.

Ethan Kholdebarin, Hospital Director, WANG Cheng, CPC Secretary, Legal Representative and Deputy Hospital Director, LI Weixin, Senior Research & Development Officer and Head of GCP Center, YU Ping, Head of Office of GCP Center and Head of Endocrinology Department, WANG Xinyuan, Chair of GCP Ethics Committee led all the investigators in the Office of GCP Center, GCP Ethics Committee, and Endocrinology Group of the GCP Center as well as Diagnostic Laboratory, ECG Room, Medical Imaging,  Medical Ultrasound and other auxiliary departments in SSMC to welcome the supervision and inspection.

Adhering to the concept of "promoting development, management and improvement through inspection", the inspection team carefully listened to the work reports of relevant departments of SSMC, performed a multi-dimensional, detailed and strict on-site inspection and review on the quality management system, hardware facilities and equipment (such as special pharmacies, material center, conversation room), the development and implementation of SOPs, first aid indications, protection of the rights and interests of subjects, data quality and traceability and others, and conducted in-depth analysis and explanations on the spot for the problems found. The inspection team also had in-depth communication with responsible persons and investigators of various specialties in SSMC on tirals, and put forward many valuable suggestions.

Afterwards, the inspection team gave a summary feedback on the inspection, and unanimously agreed that SSMC had successfully completed all the contents specified in the GCP and therefore shall be regarded as having passed the inspection. As a result, the Endocrinology Department was filed as an eligible entity to conduct clinical trials with YU Ping, head of the Department, as the PI. The inspection team also offered a few guiding suggestions for the future drug clinical trials in SSMC.

The leaders of SSMC made the following requirements: the whole hospital should pay high attention to clinical trials, and promote development and reform through evaluation; each professional group should carefully analyze the existing problems and shortcomings, and further improve medical staff’s awareness on clinical research and ethics.

SSMC’s success in passing the inspection means that it has NMPA-recognized qualifications to carry out Phase II-IV drug clinical trials in China, and that clinical trials in SSMC have been taken to the next level after obtaining the qualifications for clinical trials of medical devices. SSMC will take this inspection as an opportunity to further strengthen management and strictly follow the requirements of the NMPA and the Provincial Medical Products Administration to ensure that its drug clinical trial process is standardized, quality is reliable, and the rights and safety of subjects are protected. At the same time, SSMC will also continue to expand the scope of clinical trials, build an innovative scientific research exchange platform covering international and domestic experts and physicians, help to improve the level of medical teaching and research in SSMC and the level of clinical research on new drugs/medical devices, and strive to enable patients to have access to more and better drugs and medical devices as soon as possible.