Good Clinical Practice Training Refresher 2026: ICH-GCP E6(R3) Revision

Rated 5 out of 5
121
GCP Refresher 2026 Good Clinical Practice

Duration :

1

1 hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Successful completion provides learners with a dated, traceable and downloadable certificate for the course : 

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.

Description:

Stay current with the latest Good Clinical Practice standards. This refresher course has been fully updated in March 2026 to reflect the ICH E6(R3) revision and is designed for clinical research professionals who already hold a foundational GCP background.

Through scenario-based exercises, practical quizzes, and a final assessment, the course helps you identify knowledge gaps, consolidate your understanding, and align your day-to-day practices with evolving GCP expectations. Immediate feedback is provided throughout, and participants who complete the course receive a CPD/CEU-accredited GCP-ICH training certificate, directly accessible via our learning platform.

Who Should Enroll?

This GCP refresher training is tailored for clinical research professionals—including investigators, sponsors, study coordinators, clinical trial assistants, and ethics committee members—who need a concise yet comprehensive refresher on Good Clinical Practice. It is ideal for those looking to align their practices with the latest ICH E6(R3) guidance and uphold high-quality standards in clinical trials.

 

Topics Outlined in the Course

  • What’s new in ICH-GCP E6(R3)?
  • How have the GCP principles changed?
  • What is the IRB/IEC’s updated role?
  • What must investigators now ensure?
  • What are sponsors responsible for?
  • How is data governance evolving?
  • What’s expected in the Investigator’s Brochure?
  • How should protocols be designed or amended?
  • Which documents are essential for trials?
  • How can GCP be applied in real scenarios?

 

This certified course integrates real-life examples and assessments to facilitate a comprehensive and applied learning experience. Upon completion, participants will receive a globally acknowledged GCP-ICH training certificate, accredited with CPD/CEU credits. 

 

Curriculum:

 

Lesson 1: Introduction

 

Lesson 2: Definitions of key terms used in GCP

 

Lesson 3: The 11 principles of ICH-GCP (R3)

 

Lesson 4: Institutional review board (IRB)/ Independent Ethics Committee (IEC)

 

Lesson 5: Responsibilities of the investigator

 

Lesson 6: Responsibilities of the sponsor

 

Lesson 6: Data Governance for Investigator and Sponsor

 

Lesson 7: Clinical trial protocol and protocol amendments

 

Lesson 8: Investigator’s Brochure

 

Lesson 9: Essential Documents and Records for the Conduct of Clinical Trial

 

Conclusion

 

Glossary

 

Assessment

Author:

patricia kay
Dr. Patricia Kay
Dr. Patricia Kay is a results focused senior research management professional with over 20 years experience in the life sciences. She has a significant expertise in clinical development, health program management, strategic planning, stakeholder management, business unit operations and personnel management. Dr. Kay has a broad knowledge of cardiovascular disease, immunology, infectious diseases. She takes part in many startups boards.

Reviews:

Rated 5 out of 5
121

$95

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This course includes:
One-year access
Updated content every month
Certificate of completion

GxP-Training Benefits

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$95.00 / year

$95.00 / year

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