Since December, 1999, verified by State Food and Drug Administration, Obstetrics & Gynecology Hospital of Fudan University has been approved as a national research base and began conducting clinical trials for gynecological, obstetrical and reproduction-regulating drugs. The clinical trial institution for drugs was qualified by Shanghai Food and Drug Administraion on June 22, 2005. The following inspection as a specialty of gynecology, obstetrics and reproductive regulation (previous) was performed by State Food and Drug Administration on July 6, 2006. In the meantime, the qualification as a specialty of gynecology & obstetrics in integrated traditional Chinese and western medicine (updated) was confirmed.
The institution is supervised by Prof. Congjian Xu, Vice-President of the hospital. It has a staff of director (Prof. Jinfang Lin), chief of office (Prof. Zirong Huang), full-time secretary, quality monitors and filing clerks.
In the institution, offices and archives are specialized and assigned to related panels. Filing cabinets with locks, duplicators and communication devices including the fax, direct-dial phone and net-connected computers are assembled. Otherwise, various departments of clinical laboratory, image and pharmacy can be used, as well as reception rooms for subjects, and advanced equipments for diagnosis. In clinical trials, a sound supervising system, rational designs and standard operating procedures are ensured, and a set of management and contingency plan is ready to prevent the subjects being injured if an unexpected event happens.
The institution has a technical system for quality assurance. The qualification of sponsors and the projects of clinical trials need to be inspected by the officers, and the procedure will be totally monitored as the investigators carry out clinical trials.
Up to date, 99 persons in our hospital have participated in national GCP trainings. In the latest 3 years , 16 drugs, 6 medical equipments and 7 agents of clinical trials initiated and have being performed in our stitution . Some papers with high quality were published. The clinical trial institution for drugs in our hospital has won a certain reputation in the field of domestic medicine.
April 15, 2011