Good Clinical Practice: ICH GCP E6 R3 Training – English v1

Good Clinical Practice (GCP) Training Course – Syllabus

Course Name: Good Clinical Practice (GCP) – ICH E6 (R3) Training for Clinical Research Professionals

Course Description: This comprehensive GCP training course is aligned with the ICH E6 (R3) guideline and meets the criteria established by TransCelerate BioPharma for mutual recognition of GCP training. It provides an in-depth understanding of the updated GCP principles and the responsibilities of investigators, sponsors, and other parties to ensure ethical, compliant, and high-quality conduct of clinical trials. Upon successful completion, participants receive a GCP training certificate valid for 3 years.

Target Audience: This course is intended for anyone whose role supports the conduct, oversight, or integrity of a clinical trial. This includes investigators and site staff, sponsor and CRO personnel, IRB/IEC members, and clinical service providers. Pharmaceutical, biotech, and medical device organizations commonly require GCP training for employees and contractors whose work can affect participant safety, data integrity, or regulatory compliance.

Learning Objectives: Upon completion of this course, participants will be able to:

• Understand the ethical and scientific foundations of GCP and the updates introduced in ICH E6 (R3).
• Apply the updated GCP principles to maintain trial integrity, participant safety, and data reliability.
• Identify and carry out investigator responsibilities in alignment with R3 requirements.
• Recognize and apply sponsor responsibilities, including quality-by-design and risk-based approaches.
• Understand the shared responsibilities and collaboration among investigators, sponsors, service providers, and oversight bodies across the trial lifecycle.
• Apply records management, trial close-out, and long-term retention requirements consistent with R3.

Course Structure: The course includes twelve videos that focus on the key aspects of GCP under ICH E6 (R3), followed by a final assessment. Participants must complete all videos and pass the final assessment with a minimum score of 75% to receive their GCP training certificate.

Course Breakdown:

• Video 1: Orientation & Course Roadmap – Course objectives, structure, and certification requirements.
• Video 2: GCP Overview: Definitions and Roles – Foundational definitions and the roles of the parties involved in clinical research under R3.
• Video 3: Principles of GCP Part 1 – Detailed review of the first half of the updated GCP principles.
• Video 4: Principles of GCP Part 2 – Review of the remaining GCP principles.
• Video 5: Investigator Responsibilities Part 1 – Qualifications, resources, and oversight obligations of the investigator.
• Video 6: Investigator Responsibilities Part 2 – Protocol compliance, informed consent, and participant protection.
• Video 7: Investigator Responsibilities Part 3 – Safety reporting, deviations, and continuing oversight.
• Video 8: Sponsor Responsibilities Part 1 – Quality management, trial design, and risk-based approaches.
• Video 9: Sponsor Responsibilities Part 2 – Monitoring, oversight of service providers, and data integrity.
• Video 10: Shared Responsibilities & Collaboration Across the Trial – Coordination among investigators, sponsors, and other parties throughout the trial lifecycle.
• Video 11: Records, Close-Out & Long-Term Retention – Documentation, trial close-out, and long-term records management.
• Video 12: Final Review & Assessment Overview – Course recap and orientation to the final assessment.

Final Assessment: The assessment covers all course modules. A score of 75% is required to pass. Retakes are permitted.

Certification: Upon successful completion of the assessment, participants receive a GCP training certificate, valid for 3 years from the date of completion. The certificate meets TransCelerate BioPharma mutual recognition criteria.

Course Benefits:

• Build current GCP knowledge aligned with the ICH E6 (R3) guideline.
• Meet sponsor and regulatory training requirements with a TransCelerate mutual-recognition-aligned certificate.
• Receive a 3-year certificate recognized by participating organizations.

Time to Complete: ~2.5 hours