Master ICH GCP E6(R3):
The Next Evolution
in Clinical Trials
Master ICH GCP E6(R3):
The Next Evolution
in Clinical Trials
Navigate the complexities of E6(R3) with unmatched clarity. Become a leader in clinical trials by mastering the latest standards
31.03.2025
31.03.2025
This isn’t just another GCP training course. It’s a practical program
that streamlines clinical trial workflows and ensures compliance
with the latest ICH GCP E6(R3) updates
that streamlines clinical trial workflows and ensures compliance
with the latest ICH GCP E6(R3) updates
Master ICH GCP E6(R3) updates with a course designed to ensure an efficient transition from E6(R2)
- Blended Learning Approach100% Online: Self-paced modules with cartoons, quizzes, test cases and recorded lectures.
- Expert-Designed & CertifiedCompany-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).
- Instant feedback and progress tracking.
- Enhanced EngagementShort comprehensive cartoons to explain complex topics.
- Practical scenarios to simulate real-life cases.
- Mobile-compatible: Learn anytime, anywhere
- Accreditation
- Developed by experienced GCP auditors
- Built on real-world insights and industry best practices
- Customizable for Companies
- Registered by Transcelerate
- CPD points
Designed for Professionals Like You
Whether you’re leading a team or supporting research initiatives, this course equips you with the tools to excel
Investigator
€250
Pre-order price
Pre-order price
150€
For Clinical Investigators, Study Coordinators and other Investigator site staff.
buy this option
Monitor
€350
Pre-order price
Pre-order price
250€
For Clinical Research Associates and similar roles (e.g., Central Monitoring Associates).
buy this option
Expert
€450
Pre-order price
Pre-order price
350€
Sponsor and Service Providers clinical staff other than Monitor (e.g., Project Managers / Clinical Trial Managers), QA staff, and other similar roles
buy this option
Individual Solutions
Ideal for those who don’t fit the predefined roles but want to enhance their knowledge
of E6(R3).
of E6(R3).
Request Custom Offer
Corporate Access
Corporate access
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!