摘要:
Clinical research assistants/coordinators (CRC) have played an increasingly important role in the new drugs clinical trials in recent years. They have undertaken most of the non-medical judgment work, become an important link among investigators, sponsors and clinical trial centers, and been an important force in accelerating enrollment and ensuring quality of clinical trials. CRC is a new career, so it is very important for us to have more concern and understanding in order to develop this team successfully. Based on the results of 10 questionnaires conducted since establishment of "China CRC Home" in 2014, comparing and analyzing the data of different years, this paper describes the culture environment of CRC and SMO (site management organization, SMO) from 11 aspects including CRC/SMO's development track, their personnel composition and distribution in major cities, CRC's personnel management and SMO's commercial mode, major ways of personnel training, and so on. The status of CRC is outlined in all aspects in this paper. The aim is not only letting more investigators know their assistants, but also paying more attention to the cultivation of CRC at that the whole pharmaceutical industry. So that this young team can grow and develop in a better environment and become a strong basic force for new drugs development in China. © 2018, Chinese Journal of New Drugs Co. Ltd. All right reserved.