Good Clinical Practice for Investigators and Coordinators (ICH E6 R3)
Barnett’s ICH GCP E6(R3) course covers the essential elements for investigative sites. Presented through the lens of an Investigator, it is designed for investigators and coordinators seeking a detailed review of the ICH E6(R3) guideline's content, requirements and application. This comprehensive and interactive course can be taken at your own time and pace. For experienced investigators and coordinators, each section provides a “test-out” option to focus on new content and areas where refresher training may be needed.
Key Features of the Course Include:
- Interactive modules aligned with the core areas and requirements outlined in ICH E6(R3)
- Situational-based learning content and scenarios that align with challenges that clinical researchers encounter regularly in their roles
- Emphasis on what is new in the R3 release (Jan 2025) of ICH E6
- Knowledge assessments and case study reviews throughout the course
- Downloadable References, Glossary and Acronyms guides
- 2025 Good Clinical Practice training certificate
Course Learning Objectives:
Upon completion of the course, you will be able to:
· Describe the foundations, background and application of E6 (R3)
· Identify the key changes in E6 (R3)
· Describe the roles and responsibilities of the IRB/IEC, investigator, sponsor and service providers with respect to the planning, conduct and oversight of clinical trials, with emphasis on the responsibilities of the investigator and clinical trial site staff (CRCs)
· Identify some of the regional regulations that govern clinical trials
· Appreciate the importance of compliance to E6 (R3) and explain the impact of noncompliance
· Apply your knowledge of E6 (R3) by completing tests and challenges (based on course content)
Additional Benefits of the Course:
- Know the key regulations governing the conduct of clinical trials, including common Audit and Inspection findings
- Understand ICH GCP E6(R3) Principles, Content and Structure (including what is new)
- Describe the expectations for the Institutional Review Board (or IRB) or Independent Ethics Committee (or IEC)
- Review the detailed expectations of the Investigator, the Sponsor and Service Providers
- Know requirements for Informed Consent, Investigational Product Management, the Protocol (including Deviations management) and the Investigator Brochure throughout the lifecycle of trials
- Define Sponsor Quality Management requirements including Risk Management, Quality Assurance, Quality Control and Monitoring
- Know the standards required to ensure that the trial-related Data and Records are fit for purpose
- Describe requirements and proper management and Reporting of Safety Events (including common deficiencies)
- Understand Data Governance requirements and the appropriate management of Data Integrity, Traceability and Security to ensure accurate reporting
- Explain requirements for the management of Computerized Systems used in clinical trials by responsible parties
- Describe requirements for the management of Essential Records that are generated throughout a clinical trial
- Practice what you’ve learned through knowledge checks and application-based case studies
Sample Challenge Scenarios Included in the Course:
- Choose the actions that should be taken when dosage-related noncompliance is detected
- Identify the steps that should be taken when significant noncompliance is detected
- Identify the changes to roles and responsibilities in ICH E6(R3)
- Determine if a site is qualified to be selected by a sponsors
- Apply the steps to be taken when an informed consent form has been updated
- Correctly align the requirements and responsibilities related to data and records quality and integrity
- Select the correct findings that represents noncompliance with the corresponding E6(R3) ALCOA ++ principle.
- Determine the correct steps to be taken when planning Investigational Product management for a trial
- Correctly categorize an investigational product-related safety event
- And many more…!
Course Module Structure:
Welcome
Module 1: ICH GCP Foundations
Module 2: Regulations and Compliance
Module 3: ICH GCP E6(R3) Principles
Module 4: IRC/IEC
Module 5: The Investigator
Module 6: Informed Consent of Trial Partcipants
Module 7: Overview of Sponsor Responsibilities
Module 8: Data and Records Quality and Integrity
Module 9: Managing Investigational Products
Module 10: Managing Safety Events and Reporting
Module 11: Data Governance and Computerised Systems
Module 12: The Investigator's Brochure
Module 13: The Protocol
Module 14: Essential Records for the Conduct of Clinical Trials
Flexible Training Options:
The course is available for Individuals and Team/Organizational Training :
Hosted Training and Group Pricing for Any Size Team:
Barnett can host and manage enrollment for individuals and teams. The more participants you register, the lower the cost per user.
1-10 Users $199 per user
11-20 Users $179 per user
21-30 Users $169 per user
31-40 Users $159 per user
41+ Users $149 per user
Course Licensing for Inclusion in your Learning Management System (LMS)
License the course and seamlessly integrate it into your organization’s Learning Management System (LMS)
For Group Training and Licensing Partners, Course Demos are Available
For an additional fee, the course can be customized to meet your organization’s specific needs, such as company specific examples, logo/branding inclusion, and more.
For more information, contact Barnett at:
Customer.service@barnettinternational.com
To inquire about licensing this course for inclusion in your LMS, contact:
nganatra@barnettinternational.com
WHAT OUR CUSTOMERS SAY
Thank you! I have completed the training and generated my certificate. I think Barnett’s Good Clinical Practice for Sponsors and CROs was the most thorough GCP training I’ve ever taken!"
- Barnett On-Demand GCP course graduate
