Clinical trial investigators′ satisfaction with clinical research coordinators and discussion on managing strategy / 中华医院管理杂志

ABSTRACT

Objective To learn the investigators′ satisfaction with CRCs and to identify the shortcomings with the CRC industry or institutional management for improvement. Methods A questionnaire survey was conducted among 120 clinical trial investigators at three tertiary general hospitals in January 2018. The questionnaire covered the basics, satisfaction with CRC, and comments of the investigator on other works of the CRC. The data acquired were subject to descriptive analysis, and the count data comparison method was Fisher precise test. Results The investigators were satisfied with CRCs in general. Specifically, their satisfaction with the " sense of responsibility" , " work hours" , and " command of GCP protocols"ranged 72.6% to 83.2% . That with " initiative" , " work stability" , and " rich clinical trial experience" fell below 60.0%. Affiliation of CRCs was correlated to "initiative"(P=0.007), and "command of clinical trial schemes and trial procedures" ( P =0.043), while investigators′ satisfaction with CRCs of uncertain affiliation fell significantly. Investigators′ experience was correlated to the " command of GCP protocols" of CRCs(P=0.035 ), as the more experienced the investigator, the less their satisfaction with the CRC. Conclusions Hospitals are expected to build a CRC standardized training system and hierarchical certification system; to standardize their CRC recruitment mechanism for overall management; to enhance their budgeting capability for sufficient CRC expenses, higher investigator efficiency and assured clinical trial quality.