Good Clinical Practice (GCP) Training Course Syllabus
Course Name: Good Clinical Practice (GCP) – ICH E6 (R3) Training for Clinical Trials
Course Overview:
This comprehensive GCP course is based on ICH E6 (R3) and is designed to provide a practical understanding of Good Clinical Practice for regulated clinical trials. The course explains the updated framework in E6 (R3), including the principles of GCP, risk-proportionate quality management, fit-for-purpose processes, and the roles and responsibilities of investigators, sponsors, and other parties involved in trial conduct. The training is intended to support ethical conduct, participant safety, data integrity, and regulatory compliance throughout the clinical trial lifecycle.
Target Audience:
This course is for anyone required to complete GCP training as part of their training requirement for a regulated clinical trial.
Learning Objectives:
By the end of the course, participants will be able to:
- Understand the ethical and scientific foundations of Good Clinical Practice in clinical trials.
- Explain the key concepts and expectations introduced in ICH E6 (R3).
- Apply the principles of GCP to support participant safety, rights, well-being, and reliable trial results.
- Recognize investigator responsibilities under ICH E6 (R3).
- Recognize sponsor responsibilities under ICH E6 (R3).
- Understand shared responsibilities and the importance of coordination across parties involved in a clinical trial.
- Support data integrity, trial quality, and regulatory compliance using risk-proportionate and fit-for-purpose approaches.
Course Structure:
The course includes 12 instructional videos and a final assessment. Participants must complete all videos and pass the final assessment with a minimum score of 75% to receive a certificate of completion.
Course Breakdown:
Video 1: Orientation and Course Roadmap
Course objectives, structure, materials, and certificate requirements.
Video 2: GCP Overview: Definitions and Roles
Overview of GCP, key terminology, and the roles of the investigator, sponsor, and other trial stakeholders.
Video 3: Principles of GCP – Part 1
Introduction to the first group of GCP principles in ICH E6 (R3).
Video 4: Principles of GCP – Part 2
Continuation of the GCP principles, with emphasis on practical application to trial conduct.
Video 5: Investigator Responsibilities – Part 1
Investigator obligations relating to qualifications, oversight, and conduct of the trial.
Video 6: Investigator Responsibilities – Part 2
Continued review of investigator duties, including protocol compliance, participant protection, and trial records.
Video 7: Investigator Responsibilities – Part 3
Additional investigator responsibilities, including documentation, safety-related responsibilities, and trial management expectations.
Video 8: Sponsor Responsibilities – Part 1
Sponsor responsibilities relating to trial design, quality management, and oversight.
Video 9: Sponsor Responsibilities – Part 2
Continued review of sponsor obligations, including safety, data handling, monitoring, and essential trial processes.
Video 10: Shared Responsibilities and Collaboration Across the Trial
How responsibilities are distributed and coordinated among investigators, sponsors, service providers, and other parties.
Video 11: Records, Close-Out, and Long-Term Retention
Requirements for trial records, close-out activities, archiving, and retention.
Video 12: Final Review and Assessment Overview
Final course summary and preparation for the assessment.
Final Assessment:
The assessment covers all course modules. A score of 75% is required to pass. Retakes are allowed.
Certification:
Upon successfully passing the assessment, participants will receive a certificate of completion, valid for 3 years from the assessment date.
Course Benefits:
- Build a practical understanding of ICH E6 (R3) expectations for regulated clinical trials.
- Strengthen awareness of participant protection, data integrity, and quality management.
- Support compliance with sponsor and regulatory expectations for GCP training.
- Receive a certificate of completion valid for 3 years.
Time to Complete:
Approximately 3 hours