Introduction of Clinical Study Center
Beijing Jishuitan hospital started clinical research since the 1980s, and got the certification of "national drug clinical trial institution" in 2005, certified professions including orthopedic, burn, cardiology, respiratory, gastroenterology, neurology and rheumatology.We passed the drug clinical trial institution qualification review in 2012. Prof. Tian wei, the legal representative of Jishuitan…
Beijing Jishuitan hospital started clinical research since the 1980s, and got the certification of "national drug clinical trial institution" in 2005, certified professions including orthopedic, burn, cardiology, respiratory, gastroenterology, neurology and rheumatology.
We passed the drug clinical trial institution qualification review in 2012. Prof. Tian wei, the legal representative of Jishuitan Hospital, is nominated as Director of the drug clinical trial institution. And the GCP office is in charge of daily work. Since 2005, we successfully accomplished dozens of domestic and international multicenter drug and medical device clinical trials. In 2014, in order to optimize the service, strengthen supervision, to improve performance, we promoted the development of the function of the drug clinical trial institution, the subordinate relations of offices and positions. The GCP office is provided with management and professional business functions and attributes, becomes the core party of the clinical trial organization and operation.
Clinical trial institution (also known as Clinical Study Center, CSC) presently is equipped with special clinic room, blood collection room, drug and device warehouse, exclusive Clinical Research Assistant/Coordinator (Clinical Research Associate, referred to as "CRA; Clinical Research Coordinator, referred to as the CRC) room, and Project Manager (Project Manager, PM) workplace. The study center is also equipped with the office, conference room, reference room and other special venues and facilities.
GCP office is the core of the clinical trial institution. The sponsor, Contract Research Organization(CRO), Site Management Organization(SMO), inspection, clinical professional departments, assist department and outsourcing service providers (including central laboratory, logistics companies, etc.) work closely together under the office’s supervision.
Clinical trial institution is comply with China's relevant laws and regulations under the premise of GCP, undertaking clinical researches including drugs, medical devices, in vitro diagnostic reagent registered clinical trial, the researchers or the sponsors by post-marketing clinical research, investigations and analysis involving human medical and use of the biological behavior, including physiological, psychological, genetic, and medicine, related study.
The main business scope:
1. The sponsor initiated drugs, medical devices and in vitro diagnostic reagents of registered clinical trials and post-marketing clinical studies.
2. Sponsors and researchers initiated medical investigation involving human medical, intervention or not intrusive clinical research.
3. Organize to formulate and implement testing or research project scheme, carry out total quality management of project.
4. Ensure GCP office daily operation and sustainable developing, continuing training, making development plan, implementation of the quality control system and financial management, etc.
Beijing Jishuitan hospital started clinical research since the 1980s, and got the certification of "national drug clinical trial institution" in 2005, certified professions including orthopedic, burn, cardiology, respiratory, gastroenterology, neurology and rheumatology.We passed the drug clinical trial institution qualification review in 2012. Prof. Tian wei, the legal representative of Jishuitan…