ICH GCP E6(R3) PRACTICAL TRAINING
A modern, role-based training built for how clinical research actually works under R3
A modern, role-based training built for how clinical research actually works under R3
Learn ICH GCP E6(R3) the way FDA/EMA expect: through systems, risks, processes, and decisions
Shared theory
Role-specific practice
Skills you can immediately apply in your daily work
WHY R3 MATTERS TODAY
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ICH GCP E6(R3) is not an update — it is a complete redesign of how quality is defined and achieved in clinical trials.
- Regulators now expect:✔ risk-based thinking
✔ management of Critical-to-Quality (CtQ) factors
✔ proportionality — controls matched to risk
✔ strong Sponsor, CRO and Site oversight
✔ ALCOA++ data & records integrity
✔ documented, defensible decision-making - Yet most professionals still operate in the E6(R2) mindset, resulting in:✔ repeated findings
✔ weak oversight
✔ poor documentation logic
✔ unpredictable quality
✔ stress during audits and inspections
This training exists to bridge that gap and bring your skills to the R3 level.
WHAT THIS TRAINING IS ABOUT
- A modern, practical R3 program built around:
- systems instead of checklists
- risks instead of tasks
- decisions instead of compliance anxiety
- role-specific practice instead of generic theory
- Every participant receives:✓ solid R3 theoretical foundation (QbD, Proportionality, RBQM, Oversight, ALCOA++)
✓ practice labs designed for their real role
✓ case studies based on FDA/EMA/The QARP findings
✓ assignments that simulate real clinical scenarios
✓ international certificate
WHAT CHANGED IN R3 — AND WHAT YOU WILL MASTER
- Quality by Design (QbD)Identify CtQ factors and build your processes around them.
- Oversight as a systemUnderstand the responsibilities of Sponsors, CROs, Investigators, Vendors
- ProportionalityApply controls that match the true risk — stop over-monitoring or under-controlling.
- Data & Records Integrity (ALCOA++)Define source data, traceability, and manage digital systems correctly.
- RBQM in practiceBuild a Risk Register, QTLs, KRIs, escalation logic, and mitigation strategies
- Evidence-based decision-makingDocument decisions in a way that withstands an inspection
THE UNIQUE VALUE: ROLE-BASED PRACTICAL TRACKS
One theory.
Five different practical paths — tailored to how each role works in real life.
FOR INVESTIGATORS & SITE TEAMS
- Practice labs:• ICF errors & reconstruction
• identifying IPD + Root Cause + CAPA
• safety oversight scenarios
• Source Data reconstruction exercises - Outcomes:✔ fewer deviations
✔ clearer documentation
✔ confident PI oversight
✔ inspection-ready behaviour
FOR CRAs / SITE MANAGERS
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Practice labs:• remote monitoring drill
• identifying critical data deviations
• proper escalation and follow-up
• risk-based monitoring logic - Outcomes:✔ fewer missed findings
✔ strong documentation trail
✔ confidence in remote & centralized monitoring
✔ alignment with RBQM expectations
FOR SPONSOR TEAMS
(Clinical, Data, Safety, Medical, PV)**
- Practice labs:• decision-making on SAE, data discrepancies, protocol deviations
• mapping and assessing data flows
• Inspection Defense Simulation (EMA/FDA style) - Outcomes:✔ confident regulatory decision-making
✔ strong data governance
✔ inspection-ready responses
✔ better cross-functional communication
FOR QA, AUDITORS & COMPLIANCE PROFESSIONALS
-
Practice labs:• auditing critical processes under R3
RCA for complex deviations and issues
• classification challenge (minor/major/critical)
• reviewing oversight, TMF, vendor processes - Outcomes:✔ conducting R3-level system audits
✔ identifying systemic failures, not symptoms
✔ building effective CAPA
✔ becoming an R3-competent audit expert
WHAT YOU WILL DO DIFFERENTLY IN 30 DAYS
✔ think in systems, not tasks
✔ evaluate risks logically, not intuitively
✔ distinguish CtQ from noise
✔ document decisions like an inspector expects
✔ manage and monitor proportionally
✔ prevent deviations instead of closing them
✔ communicate professionally across roles
This is the skillset the industry now requires
✔ evaluate risks logically, not intuitively
✔ distinguish CtQ from noise
✔ document decisions like an inspector expects
✔ manage and monitor proportionally
✔ prevent deviations instead of closing them
✔ communicate professionally across roles
This is the skillset the industry now requires
WHY COMPANIES CHOOSE THIS TRAINING
- Measurable quality improvementFewer findings → fewer delays → lower operational risk
- Inspection readinessTraining content is directly aligned with EMA/FDA expectations
- Team alignmentEveryone speaks one language: CtQ, risks, QTLs, ALCOA++, oversight
- ROI in 1–2 studiesBetter processes pay for themselves quickly
PRICING TIERS
Enroll now:
Course for INVESTIGATOR
From 15 employees → €80 per person
€90
For research sites
Includes core R3 + site-specific labs
Immediate access Includes core R3 + site-specific labs
Clinical Research Associate
From 3 employees → €100 per person
€120
For CRA / Site Managers
Includes R3 monitoring track + remote lab
Immediate access Includes R3 monitoring track + remote lab
Project Manager
From 3 employees → €250 per person
€300
Full access + advanced case labs
Immediate access Sponsor Team
From 15 employees → €80 per person
€300
Full access + advanced case labs
Immediate access Quality Assurance
From 3 employees → €100 per person
€300
For QA, Compliance Teams and Auditors
Full access + advanced case labs + RCA/CAPA
Immediate access Full access + advanced case labs + RCA/CAPA
Which level is right for me?
Features
Investigator Level
For Clinical Investigators, Study Coordinators and other Investigator site staff.
Monitor Level
For Clinical Research Associates and similar roles (e.g., Central Monitoring Associates).
Expert Level
Sponsor and Service Providers clinical staff other than Monitor (e.g., Project Managers / Clinical Trial Managers), QA staff,
- General sections (Glossary, Introduction)
- GCP Principles
- IRB/IEC (Ethics Committees)
- Investigator responsibilities
- Data Governance
- Essential Records (Appendix C)
- Annex 2
8. Sponsor responsibilities relevant to monitoring activities
9. Appendices A and B
10. In-depth review of all E6(R3) sections, including complex and advanced topics
10. In-depth review of all E6(R3) sections, including complex and advanced topics
They trust us:
We really appreciate your feedback on our course!
Confirm your participation in our individual or corporate training and receive exclusive access to the E6(R2) vs. E6(R3) Key Differences Chart.
A structured, practical reference. This guide is available only to participants and designed for continued use as an essential tool during the transition process.
A structured, practical reference. This guide is available only to participants and designed for continued use as an essential tool during the transition process.
WHAT YOU’ll LEARN
Each module combines theory with practical application, ensuring you gain actionable insights
Content:
- Overview of GCP principles and evolution from E6(R2) to E6(R3).
- Emphasis on the importance of flexibility, quality by design, and risk-based and risk-proportionate approaches in clinical trials.
Content:
- Core principles for ethical and scientifically sound trials.
- Focus on participant safety, data reliability, and trial integrity.
- Outcome: Grasp the updated principles and their implications for trial design and execution.
Content:
- Roles and responsibilities of IRBs/IECs.
- Key updates in submission, review, and oversight processes.
Content:
- Investigator qualifications, IMP, informed consent, records and safety reporting.
- Updates in risk-based delegation, oversight and other items in E6(R3).
Content:
- Sponsor oversight, trial design, quality management, and safety assessment.
- Comparisons: Quality assurance, monitoring and other changes from E6(R2) to E6(R3).
Content:
- Data capture, audit trails, validation, and lifecycle management
- Enhanced focus on computerized systems in E6(R3) and their validation.
Essential Documents:
- Content: Document requirements before, during, and after trials.
- Investigator’s Brochure (IB)
- Protocol and Amendments
Content:
- Review all modules with a focus on practical application.
Get access to the ICH GCP E6(R3) course demo
Explore the content, format, and expert approach behind the program — so you can make an informed decision.
Use this opportunity to ask questions and evaluate how the course fits your professional goals.
Explore the content, format, and expert approach behind the program — so you can make an informed decision.
Use this opportunity to ask questions and evaluate how the course fits your professional goals.