药物临床试验新机构备案第三方评估问题分析OA

Objective Based on third-party evaluation reports,this study aims to explore the problems in the registra-tion of new drug clinical trial institutions and provide suggestions,in order to provide reference for medical institutions planning to register.Methods Third-party evaluation reports were collected from 23 tertiary hospitals that completed initial registration from 2020 to 2025.A total of 516 on-site inspection issues were summarized,and quantitative analysis were performed based on expert consultation.Results Newly registered institutions for drug clinical trials in China mainly have four problems:docu-ment system(52.33％),hardware facilities(23.26％),personnel qualification(20.93％),and organizational structure(3.49％).Among them,the management document system is incomplete(40.37％),the operability is weak/inconsistent with the actual situation(21.11％),the pharmacy and drug storage facilities are unreasonable(40.00％),and there is insufficient mastery of regulation and management document requirements(50.93％),and 61.82％of the problems are concentrated in the professional group.Conclusions Newly registered institutions for drug clinical trials need to improve their document system,training incentives,hardware configuration,and ethical mechanisms,and collaborate with multiple parties to improve their filing management system.This study provides a targeted improvement path for the proposed filing institution.