中国药业2026，Vol.35Issue(18)：21-24,4.DOI:10.3969/j.issn.1006-4931.2026.18.005
2020-2022年某院药物临床试验项目质量控制报告分析
Analysis of Quality Control Reports of Drug Clinical Trial Projects in a Hospital from 2020 to 2022
摘要
Abstract
Objective To provide reference for drug clinical trial institutions to improve their quality control systems.Methods The quality control reports from the Office of Drug Clinical Trial Institution of The Second People's Hospital of Huai'an from April 2020 to December 2022 were collected,statistically analyzed and summarized.Results A total of 386 times of quality control issues were summarized from 93 reports,mainly involving eight categories:original document recording issues(116 times,30.05%),electronic data capture system data entry issues(73 times,18.91%),investigational product issues(59 times,15.28%),adverse event issues(43 times,11.14%),examination and test issues(35 times,9.07%),documentation issues(21 times,5.44%),protocol deviations(18 times,4.66%),informed consent issues(13 times,3.37%)and other issues(8 times,2.07%).Conclusion Clinical trial institutions should attach importance to the supervision and inspection of each link during project implementation,strengthen investigator training,improve investigators'awareness of implementing Good Clinical Practice,and continuously enhance the quality of clinical trials.关键词
药物临床试验/质量控制报告/统计分析/药事管理Key words
drug clinical trial/quality control report/statistical analysis/pharmaceutical administration分类
医药卫生引用本文复制引用
薛乐刚,李海伦,葛秋,杨蓉,李江南,丁莹,李大伟..2020-2022年某院药物临床试验项目质量控制报告分析[J].中国药业,2026,35(18):21-24,4.基金项目
江苏省卫生健康委科研项目[H2019062] （）
江苏省医院协会医院管理创新研究课题[JSYGY-3-2024-107]. （）
