Good Clinical Practice: ICH E6 R2 Training in English v1.2 (2y)

Course Name: Good Clinical Practice (GCP) – ICH E6 (R2) Training for Clinical Trials

Course Overview:
This comprehensive GCP course aligns with ICH E6 (R2) guidelines and meets the criteria set by Transcelerate BioPharma for GCP training mutual recognition. It provides an in-depth understanding of GCP principles and investigator responsibilities to ensure ethical and compliant conduct in clinical trials.

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:

• Grasp the ethical and scientific foundations of GCP in clinical trials.
• Apply the 13 principles of GCP to uphold the integrity and quality of clinical trials.
• Identify and execute the 13 investigator responsibilities to maintain compliance with GCP standards.
• Ensure data integrity, participant safety, and regulatory compliance in clinical research.

Course Structure:
The course includes seven videos focusing on key aspects of GCP. Participants must complete all videos and pass a final assessment with a minimum score of 75% to receive a GCP training certificate.

Course Breakdown:

• Video 1: Course Introduction – Objectives, structure, and certification requirements.
• Video 2: Introduction to GCP – Overview of ICH E6 (R2) guidelines and GCP’s role in clinical research.
• Video 3: GCP Principles (1-7) – Detailed review of the first 7 ICH GCP principles.
• Video 4: GCP Principles (8-13) – Review of the remaining principles (8 to 13).
• Video 5: Investigator Responsibilities (1-6) – Examination of the first 6 investigator responsibilities.
• Video 6: Investigator Responsibilities (7-13) – Continuation of investigator duties, focusing on protocol, safety, and quality control.
• Video 7: Summary and Final Assessment – Course recap, reinforcing key GCP principles and investigator responsibilities.

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 GCP certificate, valid for 2 years from the assessment date.

Course Benefits:

• Enhance your knowledge of GCP to ensure compliance in clinical trials.
• Meet the GCP training standards recognized by regulatory bodies and sponsors.
• Receive a Transcelerate-recognized certificate valid for 2 years.

Time to Complete: ~2 hours