Integrating ICH Good Clinical Practice (GCP) Principles and Essential Documentation into Dermatology Residency Education in China.

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.