Shenzhen Samii Medical Center officially established a National Drug/Medical Device Clinical Trial Institution in June 2021. With strong support from hospital leadership and active collaboration from various departments, Shenzhen Samii Medical Center completed the registration for the medical device clinical trial institution on September 1, 2021 (Registration Number: 202100065). 

Currently registered departments include: Endocrinology, Neurology, Neurosurgery, Obstetrics & Gynecology, Cardiovascular Medicine, Urology, Anesthesiology, Diagnostic Laboratory, Medical Ultrasound, Respiratory Medicine, General Surgery, Orthopedics, Respiratory Medicine, E.N.T.. On June 21, 2022, our hospital successfully obtained the qualification for a drug clinical trial institution (Registration Number: 2022000078). The registered department is Endocrinology, Neurology, Cardiovascular Medicine, Respiratory Medicine, Anesthesiology.

I. Management framework

Our hospital places great emphasis on the operational efficiency of clinical trials and prioritizes the quality of these trials. We strictly adhere to the national clinical trial regulations, hospital policies, and Standard Operating Procedures (SOPs) in managing the conduct of clinical trials. The research teams within various specialized departments possess the necessary capabilities, and our medical institution's facilities and equipment are fully equipped to support the smooth execution of trials. Our processes are well-defined, roles are clearly outlined, and our communication channels are streamlined through digitization, ensuring the rapid, efficient, and high-quality approval and implementation of trial projects.

The Clinical Trial Institution of Shenzhen Samii Medical Center has a dedicated office with a team of 8 staff members respectively working as the Office Director, Deputy Director of the Office, Secretary, Quality Administrator, Records Administrator, and Drug/Medical Device Administrator. They collectively oversee the management of various clinical trial projects. The Clinical Trial Center is located on the 7^th floor, Finger B, of the Inpatient Building, covering a total area of 1,500 square meters. It is equipped with the Office, GCP Record Room, meeting rooms, subject reception area of different specialties, data room of different specialties, and other corresponding facilities and equipment. The Office is furnished with office desks/workstations, networked computers (both intranet and internet), direct dial telephones, all-in-one printer-copier-fax machines, shredders, and locked file cabinets. These provisions ensure the necessary conditions for efficient office operations.

Additionally, the institution has a dedicated GCP Record Room, equipped with locked and opaque file cabinets. The cabinets are classified into administrative file cabinets, ongoing project file cabinets, and completed project archive cabinets, each clearly labeled. An illustrative diagram is provided for easy retrieval and placement. The Record Room is equipped with air conditioning, fire extinguishers, cameras, anti-mold and anti-moth agents, mouse traps, blackout curtains, and ventilation. It does not have sprinkler fire suppression facilities, and the air conditioning vents are not directed towards the file cabinets. The room is equipped with a 24-hour temperature and humidity monitoring system. An alarm system is in place to detect abnormal temperature changes. Temperature and humidity records are regularly exported, printed, and archived. The Record Room meets requirements for fire prevention, water resistance, moisture prevention, theft prevention, protection against insect and rodent damage, light-shielding, ventilation, and temperature and humidity control. The keys for the file cabinets and the Record Room are held by the Record Administrator. Designated individuals manage trial archives, maintain documentation for file archiving, and implement a registration system for document access. This setup meets the archival requirements for the current specialties conducting related activities in our institution.

The staff members of the institution have signed conflict of interest declarations and confidentiality commitments regarding the review of projects, subject information, and related matters. These documents have been stored in individual personnel files. Qualification documents for personnel are kept complete, such as academic degrees, GCP training certificates, professional licenses, professional title certificates, and materials verifying participation in relevant projects and papers. All organizational management personnel have undergone training in external clinical trial techniques, GCP, and relevant regulations. They have obtained corresponding certificates. The Office of the institution has an annual training plan that regularly schedules external learning exchanges, internal training sessions, and other educational activities. All training records and materials are completely kept, including attendance sheets, training logs, training photos, training presentations, training assessment questionnaires, and training certificates. All training assessment questionnaires are reviewed, and follow-up measures are taken for individuals who do not meet the passing criteria. These measures might include requiring individuals to relearn the content and retake the exam, among other necessary steps.

In the future, we will continue to adhere rigorously to the relevant Good Clinical Practice (GCP) requirements. We will uphold a proper understanding of the value and risks associated with clinical trials, along with a deep sense of reverence. This commitment will lead us to enhance our quality control over trial projects, aiming to foster a continuous improvement in the quality of clinical trials.