Beijing Tsinghua Changgung Hospital affiliated to Tsinghua University, was established in 2014. And now it is qualified by the State Drug Administration as a clinical trial organization in more than 30 specialties, including endocrinology, neurology, cardiovascular medicine, infectious diseases, intensive care medicine, general surgery (vascular, hepatobiliary, gastrointestinal, thyroid and breast), anesthesia, orthopedics, plastic surgery, gynecology, rehabilitation medicine, dermatology and venereology, obstetrics, emergency medicine, oncology, gastroenterology, nephrology, otolaryngology, and medical imaging. In January 2018, the hospital obtained the qualification recognition of "Qualification of Medical Device Clinical Trial Organization" by the State Drug Administration. For the record, a total of 46 specialties in the hospital are certificated to conduct clinical trials of medical devices. It has a number of clinical researchers and managers with rich experience in clinical trials.
The Clinical Trials Research Institute, under the leadership of the hospital, is committed to conducting clinical trials involving human medical research, including investigator-initiated and sponsor-initiated registered clinical trials and post-marketing clinical trials involving drugs, medical devices, in vitro diagnostic reagents, in accordance with China's relevant laws and regulations and the requirements of GCP.
At present, there are several international multi-center-led, international multi-center China-led and domestic multi-center-led clinical trials of new drugs and medical devices. In addition to the research ward, central trial pharmacy, sample analysis room, and trial archives, the institution has established dedicated offices for CRAs and CRCs to meet the need for regular monitoring and follow-up.
As the hospital-wide clinical trial system and management department, the Clinical Trials Research Institutional Office is responsible for the overall management of projects. The office includes office secretary, data manager, drug manager, quality controller, financial manager and other positions. The responsibility ranges from project management, contract and funding management, quality management, file management to training management, etc. The Clinical Trials Research Institutional Office is responsible for quality control of projects in accordance with national laws and regulations, and cooperates with the State Bureau of Inspection, sponsor monitoring or third-party auditing to ensure the quality of clinical trial projects.
Work Location
The Clinical Trials Research Institutional Office is located on the west of second floor of Building #3, Beijing Tsinghua Changgung Hospital.
Reception Hours.
Reception day is all day Wednesday. Please make an appointment with the institution to visit on other days of the week, and be aware of any changes under special circumstances.
Organization Email: gcp@btch.edu.cn
Organization Phone Number:
Please contact Mr. Liu, secretary of the organization, to submit your project and communication materials: 010-56118583.
Please contact Ms. Li, Institutional Quality Control Officer for genetic office and quality control management: 010-56118766.
Please contact Mr. Chen, financial administrator of the organization for contract and expense management: 010-56118766.