Discussion on whole process management of IIT clinical research from perspective of high quality development
Investigator-initiated-trial(IIT)is the most important part of clinical researches.Based on the IIT management practice of one 3 A 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 studyquality controltotal quality managementorganization and administration
NETL
NSTL
万方数据
