Investigation and Analysis of the Current Situation of Quality Management in Drug Clinical Trial Institutions
10.3870/j.issn.1004-0781.2023.12.025
- VernacularTitle:药物临床试验机构质量管理现状调查分析
- Author:
Qin TAN
1
;
Panbo QIU
;
Gaoyang LI
;
Qingna LI
;
Fang LU
Author Information
1. 中国中医科学院西苑医院临床药理研究所,国家药品监督管理局中药临床研究与评价重点实验室,国家中医心血管病临床医学研究中心,北京 100091
- Keywords:
Clinical Trial Institutions;
Quality Management;
Risk based quality management;
Questionnaire
- From:
Herald of Medicine
2023;42(12):1884-1889
- CountryChina
- Language:Chinese
-
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.
