The Clinical Pharmacology Department of the Second Hospital of Shandong University formally passed the on-site inspection of the China National Medical Products Administration in 2004, obtained the GCP qualification, and successfully passed the re-inspection in 2017. Through unremitting efforts, it has now formed specialties with its own characteristics and academic styles, and enjoyed a fairly high reputation at home and aboard. It consists of the Phase I Clinical Research Office and the GCP Office, which can undertake various phases of clinical researches on new drugs and medical devices.
(1) GCP Office
The GCP Office is located at the fourth floor of the Office Building of the Second Hospital of Shandong University, and it is responsible for the daily affairs of clinical trials. It has a GCP Pharmacy, which is managed by full-time pharmacists. The pharmacy is equipped with a professional refrigerator and cold chain temperature control system to meet the storage and transfer conditions of clinical trial drugs and devices. It has a professional and independent Data Room for storing clinical trial related data, and it is managed by a full-time data manager. The GCP Office has a systematic and scientific management system and SOP to guide daily clinical trial work. In recent years, researchers of clinical professional departments and auxiliary departments have devoted a lot of efforts to the construction and development of the GCP Office. Since its establishment, it has undertaken and completed more than 300 domestic and international multi-center clinical trials of drugs and medical devices. It has established a good relationship with customers, as well a good reputation in the industry. We have received and passed the on-site inspections of clinical trial projects by the National Medical Products Administration and provincial medical products administrations for several times.
The specialized departments for drug clinical trials in our hospital include: cardiology, neurology, respiratory medicine, hematology, ophthalmology, neurosurgery, urology and orthopedics (joint surgery, trauma orthopedics, spine orthopedics, hand and foot surgery) and other clinical specialties. All the researchers of these specialized departments have rich clinical trial expertise, experience and capabilities. All the specialized departments have a complete management system and SOP, which can ensure the quality of clinical trials and protect the rights and safety of subjects.
(2) Phase I Clinical Research Office
The Phase I Clinical Research Office is located at the second floor of the North Tower of Wenhui Building of the Second Hospital of Shandong University. It covers an area of more than 400 square meters. It can provide clinical research services such as human pharmacokinetics studies, human bioequivalence studies, and phase I clinical trials of new drugs, etc.
The Phase I Clinical Trial Ward is equipped with 30 standard beds, and it is equipped with a subject reception room, a subject activity room, a rescue room, a sample processing room, a laboratory, and a data room. The rescue room is equipped with rescue beds, ECG monitors, defibrillators, vacuum extractor, rebreathing bag, rescue vehicles, first aid transfer boxes and other rescue equipment and first aid drugs to ensure the safety of subjects. The ward is equipped with an ECG workstation, a physician workstation and a combined medication query system connected to the hospital, which are connected to the His system and Lis system of the hospital. The ward is equipped with water heaters and ultraviolet disinfection equipment. The Research Office is equipped with the biological safety cabinet, ultra-low temperature refrigerator, low-temperature centrifuge, ice machine, cold chain temperature control system and other experimental equipment, which can meet the research requirements of drug ice-water bath and ensure the safety of test drugs and biological samples. The biological sample collection and treatment area is all equipped with yellow fluorescent lamps to meet the research requirements of light-shielding drugs.
The Research Office is equipped with full-time research doctors and research nurses. All researchers have passed GCP, “Provisions for Drug Registration” and related professional technical training. The Research Office has a complete subject management system, experimental drug management system, biological sample management system, research document management system and clinical trial quality management system. At present, it has successfully completed more than 30 human pharmacokinetics/bioequivalence research projects, including ordinary oral solid preparations, granules, suspensions, chewable tablets, etc., and it has accumulated rich clinical research experience. It has repeatedly accepted and passed the on-site inspections of test projects by the National Medical Products Administration, as well as Shandong and Sichuan Medical Products Administrations. Many experimental drugs of this research center have been approved for marketing.
The laboratory is equipped with the high-performance liquid chromatography-mass spectrometer, high-performance liquid chromatograph, low-temperature high-speed centrifuge, pipette, precision balance and other laboratory equipment, as well as the full-time drug analysis staff, which can meet the requirements of the work of monitoring the therapeutic drug’s concentration.
Contact: 0531-85875330 (Director’s Office)
0531-85875203 (GCP Office)
0531-85875756 (Phase I Clinical Research Office)
E-mail：GCP0531@126.com
Fax: 0531-85875203