将ICH良好的临床实践 (GCP) 原则和基本文档整合到中国皮肤病学住院教育中
Xiaoxia Ding1, Peijiao Wang2, Xiaohua Tao1
1Center for Plastic & Reconstructive Surgery, Department of Dermatology, Zhejiang Provincial People's Hospital (Affiliated People's Hospital), Hangzhou Medical College, Hangzhou, Zhejiang, People's Republic of China.
Advances in medical education and practice
|April 7, 2025
概括
这项研究提出了一个由三个模块组成的课程,将国际协调委员会良好的临床实践 (ICH GCP) 原则纳入中国皮肤病学住院计划,增强临床试验能力和伦理研究实践.
科学领域:
- 医疗教育 医学教育
- 临床研究 临床研究
- 皮肤病学 皮肤病学
背景情况:
- 国际协调理事会良好的临床实践 (ICH GCP) 原则对于临床试验至关重要.
- 目前,中国皮肤病学实习课程缺乏正式的ICH GCP整合.
- 提高研究素养和临床试验能力至关重要.
研究的目的:
- 提出一个新的三模块课程,将ICH GCP整合到中国皮肤病医疗住院.
- 为使中国皮肤病学实习教育与国际研究标准保持一致.
- 提高居民在进行伦理,以患者为中心的临床试验方面的技能.
主要方法:
- 一个由三个模块组成的课程,包括基础知识,子专业培训和道德.
- 模块1:基础临床研究知识 (第二年).
- 模块2:皮肤病学子专业培训与GCP原则 (3年).
- 模块3:沟通和道德培训 (第二年和第三年).
- 纳入逐步学习,实践练习和评估.
- 解决诸如资源和成本限制等实际障碍.
主要成果:
- 拟议的课程系统地整合了ICH GCP原则.
- 它涵盖了基本文件,伦理标准和关键利益相关者的角色 (IRB/IEC,调查人员,赞助商).
- 该课程强调批判性思维,跨学科沟通和道德决策.
结论:
- 拟议的课程使居民能够领导道德上合理的,以患者为中心的临床试验.
- 实施将推动基于证据的皮肤病学教育和实践在中国.
- 这种模式培养了皮肤病学现代临床研究的基本技能.
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