New
SM
Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
Implementing ICH GCP E6(R3) Annex 2 Course & Certification
Intermediate
Watch Preview
4.7
★★★★★
93% Recommended
Updated 2026
3 hours
167 active users
3 points
Watch Preview
Your Study Basket
1 x Implementing ICH GCP E6(R3) Annex 2
| Total | |
VAT is levied as per your country’s applicable rules and rates at checkout
Save more with a monthly or annual plan that includes this course
Each course includes:
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with ICH GCP E6(R3) and its Annex 2 (final version adopted 03 June 2026), together with related FDA, EMA and MHRA expectations for decentralised trials, digital health technologies and real-world data. Whitehall Training monitors regulatory developments and updates course content as guidance evolves.
Learn from Industry Experts
This course was developed by senior clinical research professionals with decades of combined experience in GCP, clinical operations, quality assurance and regulatory inspection across global trials. The content goes beyond the guideline text to give you practical, implementation-focused mastery.
Secure Payment Service
Rest assured we use secure processes to protect your payment.
Secured by:
About
This advanced CPD course provides practical training on ICH GCP E6(R3) Annex 2, adopted in final form on 03 June 2026, and its application to modern clinical trial designs. Across eight modules you will learn how Annex 2 applies to decentralised trial elements, pragmatic approaches, digital health technologies, real-world data, remote activities, home healthcare, external service providers, investigational product management, data governance, participant safety and inspection readiness. Built around the final guideline text, the course combines scenario-based learning, knowledge checks, a 30-question final assessment and ten downloadable implementation tools, including checklists, templates and a responsibility matrix.
This course provides an overview of the new considerations introduced in the ICH E6(R3) Annex 2 Guideline. It is not a formal qualification, and a valid accredited GCP certificate remains required for individuals conducting clinical trial activities.
Who Should Enrol?
- CRAs and CTAs
- Clinical Trial and Project Managers
- Clinical Operations
- Sponsor and CRO staff
- Investigator site staff, PIs and Sub-Investigators
- Research Nurses
- QA
- Regulatory Affairs
- Clinical Data Management
- Pharmacovigilance
- Vendor oversight and digital/DCT teams
What you will learn
Apply Annex 2 to decentralised, pragmatic and data-enabled trials
Use Quality by Design and proportionate risk-based approaches
Protect participant safety and rights in remote settings
Select, validate and govern digital health technologies
Course Syllabus
- Course purpose, entry requirements and learning outcomes
- How Annex 2 fits within ICH E6(R3)
- Downloadable implementation toolkit
- Why Annex 2 was introduced and its adoption on 03 June 2026
- Principles, Annex 1 and Annex 2 relationship
- Scope: decentralised elements, pragmatic elements and real-world data
- Proportionate risk-based approach and quality by design
- Hybrid designs, remote visits and telemedicine
- Home healthcare and community-based activities
- Local healthcare provider involvement and usual clinical practice
- Participant burden, accessibility and risk considerations
- Critical-to-quality factors for modern trial models
- Risk identification, prioritisation, control and communication
- Avoiding unnecessary complexity and documenting design decisions
- Practical QbD worksheet and scenario
- Investigator oversight and delegation in decentralised trials
- Remote informed consent and identity verification
- Sponsor protocol, design and oversight obligations
- Responsibility matrix across all trial parties
- Wearables, apps, eCOA/ePRO and telehealth platforms
- Technology selection, usability, validation and verification
- Data security, access controls and audit trails
- Technology failure and contingency planning
- EHRs, registries, claims and patient-generated data
- Fitness for purpose: reliability and relevance
- Sponsor access, consent and permission for RWD
- Provenance, traceability, linkage and quality checks
- Direct-to-participant shipment and local pharmacy involvement
- Temperature control, accountability, returns and destruction
- Safety monitoring across remote sources and escalation pathways
- Emergency unblinding considerations
- Sponsor, CRO and service provider oversight
- Centralised, remote and on-site monitoring strategy
- Essential records and inspection readiness
- CAPA, lessons learned and implementation roadmap
- Course summary and key takeaways
- 30-question final assessment (80% pass mark)
- CPD certification
Our Certified Customers
Learner Rating & Reviews
4.7
★★★★★★
Average Rating
536 global ratings
★★★★★
87.0%
★★★★★
5.0%
★★★★★
3.0%
★★★★★
3.0%
★★★★★
2.0%
Best Seller
