基于经验调查的分析,分析临床研究协调员 (CRC) 偏离在中国四川的指定的责任,基于经验调查
Shuxia Shi1,2,3,4, Shangyuan Qin5, Qin Yu1,2,3,4
1National Drug Clinical Trial Institution of West China Second University Hospital, Sichuan University, Chengdu, China.
Frontiers in medicine
|February 19, 2026
概括
临床研究协调员 (CRCs) 由于调查员责任不清楚,经常超越界限. 标准化CRC角色和研究者管理对于临床试验质量和患者安全至关重要.
科学领域:
- 临床研究 临床研究
- 监管科学 监管科学
- 医疗保健管理的管理
背景情况:
- 临床研究协调员 (CRC) 在临床试验中发挥着至关重要的作用.
- 超越CRC的职责可能会损害试验质量和患者安全.
- 标准化CRC角色对于高效和道德的临床研究操作至关重要.
研究的目的:
- 探索CRCs中超越行为的当前状态和原因.
- 为标准化CRC责任提供参考.
- 保护临床试验质量和受试者安全.
主要方法:
- 基于文献综述和半结构面试,开发了一个调查问卷.
- 调查问卷在线向202名临床试验利益相关者发送.
- 数据分析涉及IBM SPSS统计和R软件,并评估了内容的有效性和可靠性.
主要成果:
- 相当多的受访者 (87.62%) 将CRC角色的超越归因于调查人员对责任的不清楚理解.
- 当调查人员要求CRC执行未经授权的任务时,经常发生超越 (89.60%).
- 最常见的超越涉及CRC使用医生账户访问医院系统 (75.25%).
结论:
- 违反CRC角色界限的原因是调查人员对法规和协议的认识不足.
- 调查人员必须明确定义并履行其审判义务.
- 临床试验中心必须遵守良好的临床实践 (GCP) 准则,以提高试验效率和质量.
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