Liaocheng City No.2 People's Hospital is located in Linqing City, Shandong Province, adjacent to Hebei Province, where the Beijing-Hangzhou Canal and Beijing-Kowloon Railway, Xinggao Expressway and Deshang Expressway intersect. With a history of more than 130 years since its establishment in 1886, it has developed into a Grade 3A comprehensive hospital integrating medical treatment, teaching, scientific research and rehabilitation, with advanced equipments and reasonable personnel echelon.

 The hospital now covers an area of 440 acres, with a building area of more than 270,000 square metres, consisting of the hospital's main campus and Huamei campus, with a service radius of 100 kilometres, covering more than 30 counties and cities in the surrounding areas of Hebei, Luzhou and Henan Provinces, serving a population of about 5 million people, with nearly 40% of the patients from outside the city. The establishment of 1,498 beds, annual outpatient volume of more than 1.2 million people, annual discharge of more than 70,000 people.

 The hospital has more than 2,600 employees, more than 340 senior titles and above, more than 890 intermediate titles, 36 master's degree supervisors, 334 doctoral and master's degree students. It has completed 51 research projects at provincial and municipal levels, won more than 30 scientific and technological progress awards at provincial and municipal levels, published more than 500 papers in Chinese series and core journals, and more than 120 monographs.

 The hospital has 62 clinical departments, 17 medical and technical departments, 60 nursing units, 2 provincial key specialties, 1 provincial key specialty construction, 26 municipal key specialties, 1 municipal key specialty of traditional Chinese medicine, and 3 municipal key laboratories of gastrointestinal endoscopy diagnostic and treatment technology laboratory, molecular pathology laboratory, and paediatric respiratory laboratory.

 Our hospital began to prepare for the declaration of drug clinical trial organisations in 2019, and set up drug clinical trial organisations in early 2020, with the managing dean as the director of the organisation and the director of the pharmacy department as the director of the organisation office. An independent ethics committee was set up, with the dean as the chairman of the ethics committee, and the specialities with strong medical, teaching and research strengths in the hospital were selected for declaration.

 The drug clinical trial institution has an institutional office, a declared professional department for phase Ⅰ clinical trial research room, trial centre pharmacy, archives, auxiliary departments (laboratory, radiology, ultrasound, pathology, CT room, etc.) and other functional examination rooms.

 There are 7 full-time staff in the office of the institution, including secretary, quality control administrator, archivist, drug administrator and other positions, who are fully responsible for the management of all kinds of clinical trial projects. The total area of the institution is about 400m2, with the Director's Office, Institutional Office, QC Office, Institutional Archives, Central Pharmacy, CRC Office and so on.

 The office of the institution is equipped with office desks, networked computers, fax, copy and scanning machines, ordinary printers, shredders, direct-dial phones, water dispensers and other office equipment. Configuration in the specialised archive room: anti-theft door, 3 data cabinets, fire extinguisher, dehumidifier, air conditioner, mosquito light, temperature and humidity meter, monitoring, GPS clock, etc. The central pharmacy is equipped with: anti-theft doors, computers, 2 refrigerators, 1 cool cabinet, cold chain monitoring system, room temperature cabinets (used to store unqualified drugs and recycled packages), horizontal laminar flow table, mosquito lamps, humidifiers, thermo-hygrometers, monitoring, GPS clocks and so on.

 Since the establishment of the institution, the hospital has organised eight training sessions on GCP-related knowledge for relevant personnel outside the hospital, seven visits to study, and 28 training sessions for internal management personnel of the institution, and more than 180 people have passed the provincial training and examination and obtained GCP certificates.

 The institution has formulated 12 systems, 10 duties, 19 standard operating procedures (SOPs), 4 design specifications (SOPs) and 9 emergency plans (SOPs). The organisation has a perfect quality control and quality assurance system. The organisation implements a three-tier quality management model and has set up a quality control management team responsible for the whole process of drug clinical trials to ensure that drug clinical trials are scientific, standardised and orderly.