The ICH GCP E6(R2) to (R3) Road Map training focuses on the latest revisions in Good Clinical Practice (GCP). The ICH E6(R3) GCP Guideline incorporates key concepts from the revised ICH E8(R1) Guideline and expands on the themes of Quality by Design, not using a one-size-fits-all approach, and using the least burdensome approach to the design and conduct of clinical trials. Rather than using a checkbox mentality, critical thinking is emphasized. There is additional emphasis on selection and oversight of contract service providers, electronic systems validation and security, and the need for maintaining a risk-based approach throughout. In this webinar, learn how to successfully integrate changes into your organization and programs.

This course is recommended for clinical research professionals who have five or more years of experience. The comprehensive ICH E6(R3) training course is recommended for those who have less experience or who have a gap in GCP knowledge.

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

Course Length: 3.5 hours

Includes:

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

• Certificate of Completion

• Real Life Case Scenarios

• Post-Assessment

• Knowledge Checks

Learning Objectives

1. Identify important changes to GCP per the ICH E6(R3) guideline. 

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

3. Consider ways of planning for implementation.

Audience

The course is designed for 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