This comprehensive training program provides an in-depth exploration of the ICH E6(R3) Good Clinical Practice guideline, the globally recognized standard for the ethical and scientific quality of clinical trial design, conduct, and reporting. Finalized in January 2025, this latest revision represents a significant modernization of GCP principles, emphasizing a risk-based, proportionate approach to trial management and the integration of digital technologies. The curriculum is structured to guide participants through the entire guideline, covering the 11 fundamental principles, the expanded roles and responsibilities of sponsors and investigators, rigorous data governance frameworks, and the critical requirements for essential records. Participants will gain a thorough understanding of how to apply the new principles-based framework to ensure participant protection, data integrity, and regulatory compliance across diverse trial designs, from traditional site-based studies to decentralized and hybrid models.
This training program is based exclusively on the principles and requirements of the following international guideline:
ICH E6(R3): The International Council for Harmonization’s Guideline for Good Clinical Practice (adopted January 6, 2025). The program also references related ICH guidelines that form an interconnected framework with E6(R3), including:
This training program is designed for a broad range of clinical research professionals whose work involves the application of GCP standards, including:
Learners who successfully complete the program will receive a dated, traceable certificate that provides verifiable proof of their achievement for professional records.
We provide training programs designed to help you meet quality and compliance standards. Our courses cover GMP, GLP, GCP, GEP, GDP, and Quality Assurance.
