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Good Clinical Practice Training Refresher 2025: ICH-GCP E6(R3) Revision

 5/5

121

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:

This GCP refresher course is designed for professionals already familiar with the ICH-GCP standard who want to stay current with the latest E6(R3) revision. Developed as a practical refresher, it reviews key responsibilities of all stakeholders in clinical research. Through engaging content and assessments, this course helps you confirm your understanding and close any knowledge gaps in line with evolving GCP expectations.

Through scenario-based quizzes, exercises, and a final assessment, learners receive immediate feedback and can validate their understanding. Upon completion, participants earn a recognized certification 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:

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:

 5/5

121

I appreciated the format of the GCP inspection course offered by GxP Training. It was easy to navigate through the educational modules and ultimately the final test. The information was presented in a clear concise way.

$95

Participant(s):

Buy now

Large group ? Request a quote !

This course includes:

One-year access

Updated content every month

Certificate of completion

GxP-Training Benefits

Experts : We work with the world's top experts in GMP, GLP, GCP, GDP, regulatory affairs, QA and pharmacovigilance.
Validated : All our courses are CPD/CEU accredited and we deliver a unique, traceable and authentic certificate to each learner.
Self-paced : access 24/7 to the course during 12 months at your own rhythm.
Smooth Experience : Each course starts with a video and ends with an exam and a valid certificate.
Up-to-date : each course is updated on an annual basis to remain valid along the Regulatory Body recommendations.
Instant Purchase : one click to buy and immediate access. Get certified today.
LinkedIn compatible : get a valid certificate at the end of each training program and publish it on LinkedIn with a Unique and Secure Link to your registered certificate.
HR management : all course programs are available either individually or as a batch to HR managers in order to pilot employees Training, follow their progress and send reminders.
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LMS compliant : each course is a SCORM object that you can distribute through your corporate Learning Management System.