Investigator-initiated-trial（IIT）is the most important part of clinical researches. Based on the IIT management practice of one 3A grade hospital in Beijing, this paper analyzed the organizational structure of clinical research,the key points of scientific review and ethical review, recordation filling, contract verification and quality control, which were compared with the IIT management measures issued by the NHC one by one. According to the above , this paper puts forward some corresponding countermeasures, aiming at improving the management level and promoting high-quality development of clinical research.

clinical study  /  quality control  /  total quality management  /  organization and administration