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Navigating ICH GCP E6(R3) – Online GCP Course & Certificate

Navigating ICH GCP E6(R3) is an online ICH E6(R3) GCP course with a verifiable certificate. You learn the complete current Good Clinical Practice guideline – principles, Annex 1 and the appendices – in three self-paced microcourses with knowledge checks, pass the final certification exam and download your VIARES certificate.

Built for newcomers who need a first GCP certificate and for investigators, clinical research coordinators, CRAs, sponsor and CRO staff who need the update from E6(R2) to ICH E6(R3), adopted by the International Council for Harmonisation on 6 January 2025.

Last reviewed: October 12, 2026 · Instructor: Khilna Samat, VIARES

Sample of the VIARES Navigating ICH GCP E6(R3) certificate of achievement, signed by CEO Dietmar Eglhofer, with a personal verification code

Course at a glance

Online & self-paced

100% online, start anytime, in English.

ICH E6(R3), current version

Principles, Annex 1 and Appendices.

Verifiable certificate

PDF with a unique code. 53,000+ VIARES certificates issued.

5-day money-back guarantee

Enroll without risk.

  • Course: Navigating ICH GCP E6(R3) – the complete current GCP guideline (principles, Annex 1, appendices) plus what changed from E6(R2)
  • Provider: VIARES, an online clinical research academy founded in 2018 with 12,000+ learners
  • Format: 100% online, self-paced, start anytime, English
  • Included: introduction video, 3 interactive microcourses (Principles, Annex 1, Appendices), 3 knowledge checks, a timed final certification exam and your VIARES certificate
  • Certificate: downloadable PDF that employers can verify online at lms.viares.com (over 53,000 VIARES certificates issued)
  • Guarantee: 5-day money-back guarantee
Enroll in Navigating ICH GCP E6(R3)

Original price was: € 199,90.Current price is: € 99,90.Add to cart

5-day money-back guarantee · 100% online · start anytime

What you learn in the VIARES Navigating ICH GCP E6(R3) course

The course teaches the complete current ICH GCP E6(R3) guideline – principles, Annex 1 and the appendices – and shows what changed compared with E6(R2). It works as a first GCP certification for newcomers and as the E6(R3) update for professionals in the pharmaceutical sector, clinical researchers and regulatory affairs experts. It has 17 learning activities across 7 sections:

course sections
7
learning activities
17
interactive microcourses
3
pass mark · 30 min · unlimited attempts
70 %

An introduction video and handouts, plus a step-by-step guide to working through the program: microcourses, knowledge checks, final exam, certificate.

  • Good clinical practice: definition, purpose and objective
  • The Declaration of Helsinki and the ICH member list
  • The structure of E6(R2) vs E6(R3) and what each version emphasizes
  • The purpose of the revision and the amended principles of GCP

Knowledge check from a pool of 52 questions.

  • The IRB/IEC and its composition
  • Investigator responsibilities and the key changes, including decentralized clinical trial elements
  • Sponsor responsibilities and oversight
  • Data governance: definitions, emphasis and key takeaways

Knowledge check from a pool of 59 questions.

  • Appendix A: the Investigator’s Brochure (IB)
  • Appendix B: the clinical trial protocol and protocol amendments, including estimands and Bayesian design
  • Appendix C: essential records for the conduct of a clinical trial
  • Summary: the focus of E6(R3)

Knowledge check from a pool of 32 questions.

A timed final certification exam with knowledge questions and practice scenarios from the course. One example: a sponsor who does not plan to retain trial records securely is not following GCP, because records must be kept for the required period and made available to regulatory authorities on request. After you pass, you download your VIARES certificate and can add it to your LinkedIn profile.

Sample question: What is the main objective of the ICH GCP guideline? Answer: to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities.

Your instructor: Khilna Samat

Khilna S VIARES Clinical Research Associate Training Course Graduate

Khilna Samat

Course tutor, Navigating ICH GCP E6(R3)

Operations & Training Specialist at VIARES; former clinical research coordinator at a US site.

Full bio

Khilna Samat is the course tutor of Navigating ICH GCP E6(R3) and Operations & Training Specialist at VIARES. With a background in biochemistry, Khilna worked as a clinical research coordinator at a US site on Phase II–IV trials and as a Study Start-Up Specialist.

Global companies employing VIARES graduates

Where to learn more: our Good Clinical Practice certification guide

Want the background first – what GCP certification is, who needs it, free vs paid options and how long a certificate stays valid? Read our Good Clinical Practice (GCP) certification guide.

Frequently asked questions about the course

Work through the three microcourses and their knowledge checks, pass the timed final exam and download your PDF certificate. Every certificate carries a unique code that can be verified online.

It works as a first GCP certification for newcomers to clinical research and as the ICH E6(R3) update for professionals in the pharmaceutical sector, clinical researchers and regulatory affairs experts who already know E6(R2).

The course is self-paced, so you set the speed. Each knowledge check has a 30-minute limit and the final exam is timed, so plan an uninterrupted block of time for the exam.

Yes. Every VIARES certificate has a unique code that employers can check on the public verification page at lms.viares.com. VIARES has issued over 53,000 certificates.

Yes. VIARES offers a 5-day money-back guarantee on the course.

Start your GCP training today

Get up to date with ICH E6(R3) and earn a verifiable GCP certificate online: enroll in Navigating ICH GCP E6(R3).

Want a full career path into clinical trials? GCP is one building block of our Clinical Research Associate (CRA) certification course, which prepares you for monitoring roles. New to the topic? Start with our explainers on good clinical practice, the clinical trial protocol and data integrity.

Learner studying an online clinical research associate course on a laptop and taking notes
Navigating ICH GCP E6(R3) · Original price was: € 199,90.Current price is: € 99,90.

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