Analysis and discussion on the implementation effect of project approval review of drug clinical trials in a hospital
Objective To summarize and analyze the problems found in the project approval review of drug clinical trials at Inner Mongolia Autonomous Region People's Hospital(our hospital).Methods The"Project Approval Review Record Form"and"Project Approval Meeting Feedback"of the drug clinical trial projects from 2020 to 2022 were collected,and all the recorded problems were classified and statistically analyzed.Results The results of the project approval review showed that the approval rate of the clinical trial approval review for drugs in our hospital was 83.1 1％.The main factor affecting the issuance of the project approval review decision was the problems in the project and research team qualification documents.Conclusion Only by strictly controlling the entrance of project approval and improving the quality of project access can institutions screen out high-quality clinical trial projects.
Drug clinical trialProject approval reviewRisk assessmentQuality control
万方数据
维普
