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已发表论文

将国际协调理事会良好临床实践(GCP)原则和基本文件纳入中国皮肤科住院医师教育

 

Authors Ding X, Wang P, Tao X, Tang Y 

Received 15 November 2024

Accepted for publication 16 March 2025

Published 2 April 2025 Volume 2025:16 Pages 525—533

DOI http://doi.org/10.2147/AMEP.S506683

Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Md Anwarul Azim Majumder

Xiaoxia Ding,1 Peijiao Wang,2 Xiaohua Tao,1 Yi Tang1 

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; 2Chinese Medicine Hospital of Tiantai County, Taizhou, People’s Republic of China

Correspondence: Yi Tang, Center for Plastic & Reconstructive Surgery, Department of Dermatology, Zhejiang Provincial People’s Hospital, Hangzhou, Zhejiang, People’s Republic of China, Email tangyi@hmc.edu.cn Xiaohua Tao, Center for Plastic & Reconstructive Surgery, Department of Dermatology, Zhejiang Provincial People’s Hospital, Hangzhou, Zhejiang, People’s Republic of China, Email taoxiaohua@hmc.edu.cn

Abstract: Integrating International Council for Harmonisation Good Clinical Practice (ICH GCP) principles, including essential documentation and ethical standards, into medical education is crucial for building clinical trial capabilities and advancing research literacy. However, dermatology residency programs in China currently lack a formal framework for incorporating these principles. This perspective article proposes a three-module curriculum tailored to address this gap and align Chinese dermatology residency education with international standards. The first module, Foundational Clinical Research Knowledge, introduced in the second year of residency, covers key GCP principles, such as the roles and responsibilities of IRB/IEC, investigators, and sponsors, as well as the significance of essential documents like clinical protocols and investigator brochures. The second module, Dermatology Subspecialty Training with GCP Principles, conducted in the third year, emphasizes advanced trial design, protocol amendments, and investigator responsibilities. The third module, Communication and Ethics Training, spans both years, focusing on interdisciplinary collaboration, IRB/IEC responsibilities, and ethical decision-making. The curriculum incorporates stepwise learning, hands-on exercises, and regular assessments while addressing practical barriers such as resource and cost limitations through faculty-supported programs. By fostering critical thinking and interdisciplinary communication, this model aims to equip residents with the skills to lead ethically sound, patient-centered clinical trials, ultimately advancing evidence-based dermatology education and practice in China.

Keywords: good clinical practice (gcp) training, dermatology residency, medical education reform, ethics in clinical training, research literacy

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