医药导报2023，Vol.42Issue(12)：1884-1889,6.DOI:10.3870/j.issn.1004-0781.2023.12.025
药物临床试验机构质量管理现状调查分析
Investigation and Analysis of the Current Situation of Quality Management in Drug Clinical Trial Institutions
摘要
Abstract
Objective To understand the current situation of quality management and implementation of risk-based quality management in clinical trial institutions.Methods In the form of questionnaires,Questionnaire Star was used to create the questionnaire,which was sent to clinical trial organisations in all provinces and cities to fill in through emails and institutional WeChat groups.Results The questionnaire results from 123 clinical trial institutions from 25 provinces were included for analysis.The quality management status was as follows:104(84.6%)institutions of the main quality management mode were the internal quality control by GCP department.On average,each institution had 3、4 full-time staff for quality management,with an average of 1 full-time staff to manage 16.8 projects and 10.9 specialties.In the last three years,65(52.8%)institutions conducted training for researchers 2-3 times/year.Ninety-five(77.2%)institutions had established a clinical trial funding allocation system.Forty-nine(39.2%)institutions had established GCP informatization management system and 44(35.2%)institutions had established risk-based quality management model.In the case of coordination between the clinical trial institution and the sponsor,47(41.2%)institutions did not not aware of the sponsor's/CRO's quality management plan in their collaboration with the sponsor.Conclusion The surveyed institutions have weaknesses,such as insufficient dedicated personnel for quality management,low utilization rate of GCP information systems.The collaborative capacity between clinical trial institutions and sponsors needs to be improved,and the implementation rate of risk-based quality management is also low.关键词
临床试验机构/质量管理/基于风险的质量管理/问卷调查Key words
Clinical Trial Institutions/Quality Management/Risk based quality management/Questionnaire分类
医药卫生引用本文复制引用
谭琴,邱攀博,李高扬,李庆娜,陆芳..药物临床试验机构质量管理现状调查分析[J].医药导报,2023,42(12):1884-1889,6.基金项目
中国中医科学院科技创新工程重大攻关项目-基于风险识别与评估的中药临床试验关键环节质量控制研究(CI2021A04704). （CI2021A04704）
