The National Institutional Review Board for Clinical Trials of Drugs of our hospital obtained qualification accreditation from the National Medical Products Administration (NMPA) in October 2019, with 6 approved specialties: Respiratory Medicine, Cardiovascular Medicine, Gastroenterology, Gynecology, Urology and Pediatric (Respiratory) Specialty.
Affiliated to the Pharmacy Dept, the institutional review board is headed by the hospital president. An institutional office is set up under it, with positions including Director of Institutional Office, Deputy Director of Institutional Office, Secretary, Quality Manager, Document Manager and Drug Manager. The institutional office takes overall charge of managing all clinical trial projects, and delivers services, supervision, coordination, organization and training for all specialized clinical departments.
The institution is equipped with a dedicated GCP central pharmacy, document archive and academic meeting room. Full-time pharmacists are assigned to the GCP central pharmacy to implement standardized centralized management of investigational products. Each approved specialty has dedicated wards and outpatient clinics for clinical trials, complete supporting equipment for trial implementation, as well as emergency medicines and resuscitation devices for severe adverse events. In addition, medical technology auxiliary departments (Pharmacy Dept, Clinical Lab, Ultrasound Room, Medical Imaging Dept, etc.) are incorporated into the full clinical trial management system to participate in trial execution. The Medical Affairs Dept, Information Dept, Emergency Center and Intensive Care Unit (ICU) provide all-round support. The hospital’s mature emergency response system and independent Ethics Committee for Clinical Trials of Drugs and Medical Devices fully satisfy the requirements for conducting clinical trials and guarantee smooth trial operation.
More than 200 investigators of our hospital have completed national-level GCP training and obtained corresponding qualification certificates. In accordance with the requirements of Good Clinical Practice (GCP), the institution has formulated a complete set of systematic clinical trial management systems, standard operating procedures and specifications to administer the whole lifecycle of clinical trials. Annual training on GCP regulations and technical operations is organized to strengthen investigator team development and optimize the quality control system. All trial projects are conducted in strict compliance with GCP principles and trial protocols to protect subject safety, ensure data authenticity and achieve high-quality completion of all clinical trial programs.
Clinical trials acceptable to the institution are listed as follows:
1. Phase I clinical trials of new drugs (pharmacokinetics, bioequivalence / bioavailability trials)
2. Phase II–IV clinical trials of drugs
3. Clinical trials of medical devices
4. Clinical trials of in vitro diagnostic reagents
5. Non-registration drug-related clinical trials initiated by sponsors or investigators
Contact Information
Institutional Office: Ms. Qin
Tel: 0755-85278975, 15626049540, 18475392977
Fax: 0755-85278975
Address: 16th Floor, Comprehensive Building, Shenzhen Bao'an District Songgang People's Hospital, No.2 Shajiang Road, Songgang Subdistrict, Bao'an District, Shenzhen
Postal Code: 518100
On November 1, 2018, our hospital completed the filing formalities for the Medical Device Clinical Trial Institution with the National Medical Products Administration (NMPA) (Filing No.: Xie Lin Ji Gou Bei 201800376). A total of 32 specialties across 16 departments have been successfully filed, basically covering all departments capable of conducting medical device clinical trials, including the Department of Rehabilitation Medicine, Department of Traditional Chinese Medicine, Stomatology Dept, Neonatology, Pediatrics (3 sub-specialties), Gynecology Dept, Obstetrics Dept, Respiratory Medicine Dept, Gastroenterology Dept, Cardiovascular Medicine Dept, Urology Dept, General Surgery, Pathology Dept, Medical Imaging Dept, Ultrasound Room and Clinical Lab, among which there are 12 clinical departments and 4 medical technology departments. After filing, these 32 specialties can cooperate with medical device research and development institutions to carry out medical device clinical trials.
More specialized departments and investigators in our hospital will participate in medical device clinical trials. Meanwhile, the Clinical Trial Institutional Office will keep strict quality control and deliver solid work to further strengthen institutional development of clinical trials. In full compliance with Good Clinical Practice (GCP) and relevant laws and regulations, the office will promote standardized, orderly and law-based clinical trial operations.
Contact Information of Medical Device Clinical Trial Institution, Shenzhen Bao'an District Songgang People's Hospital
Ms. Qin
Tel: 0755-85278975, 15626049540, 18475392977
Our hospital officially established the Phase I Clinical Trial Research Unit in August 2018, forming a Phase I research team led by hospital administrators. The team consists of 4 full-time and part-time physicians, 5 full-time and part-time nurses, 2 full-time and part-time pharmacists, and several other relevant research staff, including 2 PhD holders and 4 master’s degree holders. Professor Fang Yi from Peking University People’s Hospital is appointed as the Honorary Director and Academic Leader of the Phase I Clinical Trial Research Unit. All full-time and part-time staff have received national or provincial GCP training and hold corresponding post qualifications.
Located on the 16th floor of the new inpatient building, the research unit covers a usable area of approximately 1,100 square meters with 34 research beds and 8 clinical observation rooms plus 1 emergency resuscitation room. It has complete management systems, standard operating procedures and emergency response plans. Functional zones include subject reception room, physical examination screening room, activity room, catering room, resuscitation room, document archive, physician office, CRC/CRN office, sample processing room, sample storage room, and investigational product processing & storage room.
The unit is equipped with an all-round monitoring system, emergency call system and access control system. The adopted electronic data information system integrates functions of subject screening, personnel management, project management, subject management, sample management and equipment management to realize standardized and efficient trial implementation. A real-time electronic monitoring system enables dynamic observation of subjects participating in innovative drug trials and ensures traceability of all data and test results. A temperature and humidity monitoring system guarantees proper storage of investigational products and biological samples. The unit is fully equipped with resuscitation devices including ventilators, ECG monitors, defibrillators and sputum aspirators, and a dedicated emergency green channel is available to safeguard subject safety.
The Phase I Clinical Trial Research Unit is qualified to conduct consistency evaluation of quality and therapeutic effects for generic drugs as well as clinical research on innovative drugs.
Brief Introduction to Phase I Clinical Trial Research Unit
