Retrospective analysis and work suggestions for the first examination of drug clinical trials in Hunan
Objective To summarize the obvious problems in the first inspection of the new filing in the drug clinical trial institutions,and to determine the key points in the supervision of the new institutions.Methods The problems in the first supervision and inspection of the new filing institutions of Hunan in 2023 were summarized.Results The responsibility consciousness of some institutions was poor,with weak internal quality control.The quality awareness of clinical departments need improvement and clinical departments didn't pay enough attention to the quality management of clinical trials.Conclusion Enough attention should be paid to the first inspection,focusing on targeted inspection plans,scores and grades of the inspection results,and strengthening the supervision and control of new institutions.
drug clinical trial organizationfirst record inspectionwork suggestion
NETL
NSTL
万方数据
