This ICH E6(R3) Good Clinical Practice (GCP) Refresher Course is designed for experienced clinical research professionals who already possess a foundational understanding of GCP. Building on core GCP knowledge, this refresher emphasizes the key changes from E6(R2) to E6(R3) and reinforces essential responsibilities for investigators, sponsors, CRO personnel, site staff, and other stakeholders involved in clinical trials.

Content includes an overview of GCP and the GCP principles; essential records; informed consent and ethics committees; computerized systems and data governance, and good documentation practices including ALCOA+. The course focuses on practical application, offering real-life case scenarios to apply what you have learned.

This refresher course supports ongoing GCP and regulatory compliance across all phases of clinical research. It is ideal for individuals who have previously completed comprehensive GCP training and need an efficient, focused update on current standards outlined in ICH E6(R3). The training includes real-life case scenarios to apply what you have learned.

This course can be used alone or as part of the full curriculum; for more information refer to the additional information below.

Course Length: 90 minutes

Includes:

• Unlimited access to the content for 45 days from your initial day of purchase.

• Certificate of completion

• Case Studies

• Post-Assessment

• Knowledge Checks

Learning Objectives

1. Apply critical thinking techniques for effective implementation of the global Good Clinical Practice Guideline, ICH E6(R3).

2. Discover how the changes in the guideline affect organizational processes and stakeholder roles and responsibilities.

3. Reflect on challenges and opportunities in implementing the GCP guideline.

4. Identify practical applications of the guideline in your work processes.

Audience

The course is designed for experienced clinical research professionals, including sponsor and CRO personnel, investigators and site staff, or others involved in GCP activities.

ONBOARDING OR ANNUAL REVIEW CURRICULUM

This course can be used alone or as part of the full curriculum, including:

1. Good Documentation Practices and ALCOA-C - Available HERE

2. Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH E2A) - Available HERE

3. Structure and Content of Clinical Study Reports (ICH E3) - Available HERE

4. Overview of 21 CFR 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA) - Available HERE

5. Overview of 21 CFR Part 50 Human Subject Protection and 21 CFR Part 56 IRB/IEC - Available HERE

6. Overview of 21 CFR Part 11 Electronic Data / Signatures & 21 CFR Part 54 Financial Disclosure - HERE