Advanced Certificate in ICH-GCP E6 (R3): Strategy, RBQM & Digital Trials

Future-Proof Your Clinical Research Career

The transition from R2 to R3 is not just an update; it is a fundamental shift in how clinical trials are designed and monitored. The industry is moving away from “tick-box compliance” toward Quality by Design (QbD).

This course is built for Principal Investigators, CRAs, Project Managers, and QA professionals who need to operationalize the 11 Principles of ICH-GCP E6(R3) immediately.

What You Will Master

• The R3 Delta: Navigate the new “fit-for-purpose” approach and the two-annex structure (Interventional vs. Non-traditional).
• Risk-Based Quality Management (RBQM): Learn to design a Quality Management Plan that identifies “Critical to Quality” factors before the trial starts.
• Digital Governance: Manage data integrity across wearables, eConsent, and decentralized platforms (DCTs).
• Vendor Oversight: Clearly define responsibilities between Sponsors, CROs, and IT vendors to prevent regulatory gaps.

Course Curriculum

Module 1: The Paradigm Shift

• Evolution of GCP: R2 vs. R3
• The 11 Core Principles & The Two-Annex Structure
• Implementing a Culture of Quality (QbD)

Module 2: RBQM in Action

• Identifying Critical to Quality (CtQ) Factors
• Risk Assessment Workshops & Tolerance Limits (QTLs)
• Risk Reporting under new guidelines

Module 3: Data Governance & Technology

• The Modern Data Lifecycle (Wearables, EHRs)
• Computerized Systems Validation (CSV) for AI/Agile systems
• Data Integrity 2.0 (ALCOA++ in decentralized trials)

Module 4: Roles & Oversight

• The Modern Investigator: Oversight of non-clinical staff
• Sponsor Oversight: Managing IT vendors and CROs
• Informed Consent: eConsent and dynamic models

Module 5: Advanced Operations

• Decentralized Clinical Trials (DCTs)
• Pragmatic & Adaptive Trial Designs
• The Digital TMF: Reconstruction of the trial

Certification & Recognition

Upon passing the final capstone assessment, you will be awarded the Certified ICH-GCP E6 (R3) Practitioner credential.

• Verifiable Digital Badge: Showcase your expertise on LinkedIn and professional portfolios.
• Continuous Relevance: Access to updates as the R3 guideline is finalized and amended.
• Leadership Signal: Prove to sponsors and employers that you are ready to manage complex, technology-driven trials.