| 摘要: |
| 目的:分析与总结苏州大学附属儿童医院临床试验机构质控中发现的问题。 方法:按照国家药品监督管理局食品药品 审核查验中心最新发布的核查要点对 2021 年 1 月-2023 年 6 月机构质控报告中的问题进行整理与归类。 结果:本机构临床试 验项目质控中发现的问题主要集中在研究人员资质文件收集、知情同意书签署、异常值评判、试验数据记录等方面。 结论:临床 试验机构、伦理委员会、研究者和申办方均应履行各自职责,对试验质量全程把关,保障受试者的权益与安全、保证临床试验数 据的真实性。 |
| 关键词: 机构质控 核查要点 问题分析 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2024.07.008 |
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| 基金项目:苏州市科技局临床试验机构能力提升项目,编号 SLT201946。 |
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| Common Problems in Quality Control of Clinical Trials According to the New Key Points for Verification |
| Zou Yaru, Jin Huizhen, Du Rao, Mao Chenmei |
| ((Children’s Hospital of Soochow University, Jiangsu Suzhou 215025, China)) |
| Abstract: |
| Objective: To analyze and summarize the problems in quality control of clinical trials in Children’ s Hospital of Soochow University. Methods: According to the latest key points for verification issued by Center for Food and Drug Inspection of National Medical Products Administration, the problems in quality control reports from Jan. 2021 to Jun. 2023 were sorted out and classified. Results: The problems found in the quality control of clinical trials mainly focused on the collection of investigators’ qualification documents, signing of informed consent, judgment of outlier and records of clinical trial data. Conclusion: Clinical trial institutions, ethics committees, investigators and sponsors should perform respective responsibilities to check the quality of clinical trials throughout process, protect the rights and safety of subjects and ensure the authenticity of clinical trial data. |
| Key words: quality control key points for verification problem analysis |
