ICH GCP E6(R3) PRACTICAL TRAINING for QA, Sponsor, CPMs, Investigators & Monitors
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
Practical GCP training for real studies, not 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 PROJECT MANAGERS (CRO & SPONSOR)
- Practice labs:• building a Risk Register + QTLs
• Vendor Failure scenario (labs, imaging, data providers)
• Oversight File audit simulation - Outcomes:• managing studies as risk-based systems
• predictable operational quality
• clean documentation for Sponsor oversight
• fewer escalations, smoother inspections
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
Programme Overview
ICH GCP E6(R3) – Role-Based Practical Training
ICH GCP E6(R3) – Role-Based Practical Training
A scenario-driven programme built on real audit and inspection findings, delivered on a single platform with five role-specific learning tracks.
All courses share a common regulatory foundation, followed by role-adapted practicums reflecting real responsibilities in clinical trials.
All courses share a common regulatory foundation, followed by role-adapted practicums reflecting real responsibilities in clinical trials.
Common Core (identical across all roles)
- 1. GCP Evolution: E6(R2) → E6(R3)• What changed, why it changed, and how it is assessed
• Implementation timing, structure, scope, and intent - 2. Glossary & Terminology Updates• New, updated, and removed terms
• Interpretation pitfalls seen in audits and inspections
- 3. The 11 ICH GCP Principles (R3)• Principles 1–11
• Each principle includes a micro-practicum and knowledge check - 4. IRB / IEC Fundamentals under R3• Approvals, continuing review, communication, documentation
Role-Based Practical Tracks (after the common core)
Learners follow one dedicated track, with practicums adapted to their real decision-making role:
- Investigator TrackFor PI, Sub-I, study coordinators, pharmacy, site staff
Focus:
• Site conduct, participant safety, informed consent
• Protocol compliance, deviations, IP handling, records
Key outcome:
• Site-level playbooks, checklists, and inspection readiness - Monitor / CRA TrackFor CRAs, CTMs, regional leads
Focus:
• Risk-based monitoring under R3 (CtQ-driven)
• Issue detection, escalation, and documentation
Key outcome:
• Risk-based monitoring toolkit and scenario exams
- Sponsor TrackFor biotech & pharma sponsor functions
Focus:
• End-to-end sponsor responsibility
• Quality by Design (CtQ, QTLs), oversight, safety, data, reporting
Key outcome:
• Oversight models and governance templates - Quality Assurance TrackFor sponsor and CRO QA auditors
Focus:
• Independent assurance
• Oversight effectiveness, CAPA, noncompliance governance
Key outcome:
• Audit checklists and CAPA effectiveness frameworks - Project Management TrackFor CTMs, PMs, programme managers
Focus:
• Operationalisation of sponsor systems
• Vendors, timelines, risks, escalation, delivery governance
Key outcome:
• Operational plans, RACI models, trackers
Practicum-Driven Learning Model
Every module ends with a role-specific practicum, including:
✔ Short case vignette based on real findings
✔ Closed-ended decision questions
✔ Answer key aligned with E6(R3) expectations
What Is Included
• One shared regulatory foundation
• One role-specific execution path
• Practical scenarios derived from audits and inspections
• Comprehensive final assessment
• Bonus: R2 → R3 Transition Tool
• One shared regulatory foundation
• One role-specific execution path
• Practical scenarios derived from audits and inspections
• Comprehensive final assessment
• Bonus: R2 → R3 Transition Tool
How the Programme Works
One shared foundation. Five specialised execution paths.
This programme ensures:
- Сonsistent interpretation of ICH GCP E6(R3) across functions
- Role-specific practice of real trial decisions
- Alignment between Investigators, Monitors, QA, Sponsors, and Project Management
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
ABOUT THE TRAINER
- Maxim BunimovichInternational GCP Auditor• Conducted audits across EU & US regions
• Extensive experience with imaging vendors, Phase I units, central labs, CRO oversight
• Creator of the CSV training program for GCP auditors
• Over 500 audit findings analyzed and classified
• Works with Almirall, Menarini, AEMPS, Telix, EU-funded studies
A trainer who uses R3 every day — not someone who only teaches it.
TRAINING FORMAT
✔ 3-5 hours of theory and practical labs per role
✔ 8 weeks access
✔ final applied assignment
✔ international certificate + CPD points
✔ online, self-paced
PRICING TIERS
Enroll now:
Course for INVESTIGATOR
€150
€150
For research sites
Includes core R3 + site-specific labs
Immediate access Includes core R3 + site-specific labs
Clinical Research Associate
€200
€200
For CRA / Site Managers
Includes R3 monitoring track + remote lab
Immediate access Includes R3 monitoring track + remote lab
Quality Assurance
€300
€300
For QA, Compliance Teams and Auditors
Full access + advanced case labs + RCA/CAPA
Immediate access Full access + advanced case labs + RCA/CAPA
Team & Enterprise Training
Save 30% for groups of 15 or more. Align your entire team with the ICH E6(R3) framework at a significantly reduced cost per person.
Save 30% for groups of 15 or more. Align your entire team with the ICH E6(R3) framework at a significantly reduced cost per person.
Most popular questions
This programme is designed for professionals and teams working in clinical research: QA, CRAs/monitors, CRCs, CPMs, investigators, and sponsor/CRO staff.
If you are involved in running studies, audits, or preparing for inspections, you are in the right audience.
If you are involved in running studies, audits, or preparing for inspections, you are in the right audience.
Most GCP trainings simply repeat the guideline; this course starts from real inspection and audits findings and real-life study situations.
You work through practical cases and typical mistakes, so you learn to make decisions instead of just listening to slides.
You work through practical cases and typical mistakes, so you learn to make decisions instead of just listening to slides.
Yes. Each participant receives an individual certificate that clearly states their name, the topics covered (ICH GCP E6(R3), role-specific modules), the date, and the duration of training.
This certificate can be used as documented evidence of GCP training in audits and inspections and can be directly integrated into your training matrix and personnel qualification records.
This certificate can be used as documented evidence of GCP training in audits and inspections and can be directly integrated into your training matrix and personnel qualification records.
Yes, the programme is built around ICH E6(R3) principles and current EMA/FDA inspection expectations for digital and data‑driven trials.
We translate the requirements into clear actions for investigators, monitors, project managers and QA so you understand what inspectors actually look for in practice.
We translate the requirements into clear actions for investigators, monitors, project managers and QA so you understand what inspectors actually look for in practice.
Yes, there are formats for individual professionals and corporate versions for teams and departments.
You can start as an individual participant and later invite colleagues or order a dedicated cohort for your organisation.
You can start as an individual participant and later invite colleagues or order a dedicated cohort for your organisation.
Yes. The programme is built around current EMA and FDA inspection focus areas, including risk-based quality management, proportionality, oversight, and data integrity.
Content reflects how inspectors actually assess compliance under ICH GCP E6(R3) in real inspections, not just a theoretical discussion of the guideline
Content reflects how inspectors actually assess compliance under ICH GCP E6(R3) in real inspections, not just a theoretical discussion of the guideline
The core programme is currently delivered as an online, self‑paced e‑learning course with practical labs and an applied assignment.
For organisations, we can customise this into hybrid formats (e‑learning plus live sessions) or dedicated in‑person workshops, adapted to your teams, timelines, and inspection pressure so training does not block operations.
For organisations, we can customise this into hybrid formats (e‑learning plus live sessions) or dedicated in‑person workshops, adapted to your teams, timelines, and inspection pressure so training does not block operations.
The programme is designed to fit around a full‑time role.
Typically it requires 3–4 hours per week for materials, case work, and live Q&A sessions.
Typically it requires 3–4 hours per week for materials, case work, and live Q&A sessions.
The goal is to reduce the risk of errors, findings, and costly rework – not just to issue a document.
You can apply what you learn directly to your current projects and use the outcomes of the training as a concrete argument when your performance or role is evaluated.
You can apply what you learn directly to your current projects and use the outcomes of the training as a concrete argument when your performance or role is evaluated.
Yes, each participant receives an individual, named certificate confirming successful completion of the training. The certificate specifies the covered topics (including ICH GCP E6(R3) and role-specific modules), training date, and total duration.
The training is registered with TransCelerate.
The certificate may be used as objective evidence of GCP training during audits and regulatory inspections and can be formally incorporated into the organization’s training matrix and personnel qualification records.
The training is registered with TransCelerate.
The certificate may be used as objective evidence of GCP training during audits and regulatory inspections and can be formally incorporated into the organization’s training matrix and personnel qualification records.
Individual professionals can enrol in the course by completing the registration form and selecting ENROLL NOW
Teams and companies can use the REQUEST CORPORATE TRAINING form, indicate number of people and roles, and we will come back within 1 business day with programme options and a clear budget.
Teams and companies can use the REQUEST CORPORATE TRAINING form, indicate number of people and roles, and we will come back within 1 business day with programme options and a clear budget.
Ready to upgrade your skills to the R3 level?
Choose your track and start learning today
Choose your track and start learning today
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