ICH GCP E6(R3) Training – Online Certification Course for Clinical Research
Comprehensive Training for Clinical Research Professionals
Course Start Date: March 31
Format: Online, available 24/7
Instructors: International GCP auditors
Certification: Transcelerate-accredited with CPD points
MASTER ICH GCP E6(R3) UPDATES WITH A COURSE DESIGNED TO ENSURE AN EFFICIENT TRANSITION FROM E6(R2)
MASTER ICH GCP E6(R3) UPDATES WITH A COURSE DESIGNED TO ENSURE AN EFFICIENT TRANSITION FROM E6(R2)
The transition to ICH GCP E6(R3) introduces critical regulatory changes that impact sponsors, research sites, and CROs:
- Risk-based monitoring and quality control are now central to compliance
- Adaptive processes enable more flexible trial management
- Revised investigator and sponsor responsibilities emphasize enhanced oversight, data integrity, and delegation
- Increased regulatory focus on digital systems requires validated data management and security.
Our course provides a comprehensive roadmap for successful adoption of E6(R3), enabling organizations to minimize compliance risks, optimize operational efficiency, and align with updated regulatory expectations.
Our Key Advantages for You:
Our Key Advantages for You:
-
Blended Learning Approach
100% Online: Self-paced modules with cartoons, quizzes, test cases and recorded lectures. -
Expert-Designed & Certified
Company-specific examples and challenges- Integrate tailored scenarios.
- Can be used for the study start (Investigators meeting and etc)
- Can be customized for other professionals or parties to whom the investigator has delegated trial-related activities
- Gamification Features (leaderboards, badges, and rewards).
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Enhanced Engagement
Short comprehensive cartoons to explain complex topics.- Practical scenarios to simulate real-life cases.
- Mobile-compatible: Learn anytime, anywhere
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Accreditation
- Registered by Transcelerate
- CPD points
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Customizable for Companies
- Customizable course content to align with company-specific needs
- In-person training sessions led by certified experts
- Option to develop a bespoke training module on your corporate platform
Secure your team’s expertise in ICH GCP E6(R3) –
30% off until March 20, 2025.
Prepare for upcoming regulatory changes with industry leading training
30% off until March 20, 2025.
Prepare for upcoming regulatory changes with industry leading training
The course is designed for both team training and individual self-paced learning.
Corporate Training
5–15 employees → from €100 per person
15–50 employees → from €80 per person
50+ employees → custom pricing available
- For Pharmaceutical and biotechnology companies
- Contract Research Organizations (CROs)
- Research sites and clinical institutions
- Other clinical research service providers
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Course for INVESTIGATOR
€150
€105
For Clinical Investigators, Study Coordinators and other Investigator site staff.
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Course For MONITOR
250€
175€
For Clinical Research Associates and similar roles (e.g., Central Monitoring Associates).
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Course For EXPERT
350€
245€
Sponsor and Service Providers clinical staff other than Monitor (e.g., Project Managers / Clinical Trial Managers), QA staff, and other similar roles
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WHAT YOU’ll LEARN
Explore a comprehensive program designed to simplify the complexities of E6(R3). 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.
Learn the Skills That Define
the Future of Clinical Trials!
the Future of Clinical Trials!