Comprehensive online GCP training aligned with EU Directives, ICH E6(R3), and international standards — trusted by European clinical research professionals, sponsors, investigators, and CROs. Self paced. 21 CFR Part 11 compliant certificates. Inspection ready training records.
The European Union has a comprehensive regulatory framework for Good Clinical Practice (GCP) that is governed by EU Directive 2001/20/EC and implemented through Directive 2005/28/EC, which lays down the principles and detailed guidelines for GCP as regards investigational medicinal products for human use. The EU framework is aligned with the ICH E6(R3) Good Clinical Practice guideline.
| Market | Framework | Application |
|---|---|---|
| European Commission | Directive 2001/20/EC | Clinical trials on medicinal products for human use |
| European Commission | Directive 2005/28/EC | Principles and detailed guidelines for GCP |
| European Commission | Regulation (EU) No 536/2014 | Clinical Trials Regulation (applicable from 31 Jan 2022) |
| EMA | ICH E6(R3) GCP | International ethical and scientific quality standard |
| National Authorities | Member State Competent Authorities | Inspection and enforcement |
All courses are self paced, available online, and include 21 CFR Part 11 compliant certificates with verifiable IDs — accepted as documented training records during EMA, MHRA, and other regulatory inspections.
This training program defines the complete knowledge and performance requirements for personnel involved in clinical research to become certified global auditors for Good Clinical Practice (GCP).
The program integrates GCP requirements from ICH E6(R3), Health Canada Part C, Division 5, and FDA regulations (21 CFR Parts 50, 56, 312, 314.50, and 314.80) with auditing practices based on ISO 19011:2026 for internal, second-party (vendor/CRO/site audits), and global regulatory compliance auditing.
This comprehensive training program provides an in-depth exploration of the ICH E6(R3) Good Clinical Practice guideline, the globally recognized standard for the ethical and scientific quality of clinical trial design, conduct, and reporting.
Finalized in January 2025, this latest revision represents a significant modernization of GCP principles, emphasizing a risk-based, proportionate approach to trial management and the integration of digital technologies.
Enroll in Good Clinical PracticesThis comprehensive training program is designed to provide individuals with a thorough understanding of ISO 19011:2026, "Guidelines for Auditing Management Systems."
The program covers all aspects of the standard, including the principles of auditing, managing an audit programme, conducting management system audits, and evaluating the competence of individuals involved in the audit process.
Enroll in ISO 19011:2026This comprehensive training program provides clinical research professionals with the knowledge and practical skills required to conduct clinical trials in compliance with Health Canada Food and Drug Regulations (Part C, Division 5) and the ICH E6(R3) Good Clinical Practice (GCP) guideline.
The curriculum is aligned with Health Canada's adoption of ICH E6(R3) effective April 1, 2026.
Enroll in Good Clinical PracticesThis training program is designed to provide organizations and individuals with a comprehensive understanding of the legal, regulatory, and operational requirements for protecting health information in clinical research and healthcare delivery settings.
Enroll in HIPAA ClinicalGCP training is a regulatory requirement for all personnel involved in the conduct of clinical trials in the EU.
EU Member State competent authorities conduct GCP inspections of clinical trial sites, sponsors, and CROs to verify compliance with GCP requirements. Inspection findings can have serious consequences:
Common EU GCP inspection observations include:
Our 21 CFR Part 11 compliant certificates provide auditable, documented training records that EU inspectors accept during inspections.
The European Union is a founding member of the International Council for Harmonisation (ICH) and actively participates in the development of global GCP standards. Understanding this international context is essential for EU clinical research professionals who design, conduct, or monitor multinational clinical trials.
The ICH E6(R3) Good Clinical Practice guideline is the internationally accepted standard for the ethical and scientific quality of clinical trial design, conduct, and reporting. The European Medicines Agency (EMA) and all EU Member States have adopted this guideline, ensuring that data generated in compliance with ICH E6(R3) is accepted by regulators worldwide, including the FDA and Health Canada.
The EU's Clinical Trials Regulation (EU) No 536/2014 has set a new benchmark for transparency and efficiency in clinical research. Our GCP training programs are aligned with both this Regulation and ICH E6(R3), equipping you to conduct trials that meet the highest European standards while remaining compliant with global expectations.
Clinical trial data generated in the EU is frequently used to support Marketing Authorisation Applications (MAAs) not only in Europe but also in the US and other regions. Our GCP courses cover the principles recognized by all major regulatory authorities, including the EMA, FDA, and WHO, ensuring your clinical data is submission-ready for a global market.
Need to upskill your entire clinical operations, quality assurance, or auditing team? We offer flexible group enrollment options for EU-based pharmaceutical companies, CROs, and research sites of all sizes. Get a custom quote for your team within 24 hours and ensure organization-wide GCP compliance with the latest ICH E6(R3) and EU Clinical Trials Regulation standards.
| Feature | GxP Trainings |
|---|---|
| EU Directives 2001/20/EC and 2005/28/EC aligned | |
| ICH E6(R3) GCP aligned | |
| Clinical Trials Regulation (EU) No 536/2014 covered | |
| FDA 21 CFR Parts 50, 56, 312 covered | |
| ISO 19011 auditing principles covered | |
| 21 CFR Part 11 compliant certificate | |
| Self paced — study on your schedule | |
| Instant certificate download | |
| Verifiable certificate ID | |
| Group / corporate enrollment |
Yes. EU regulators do not mandate a specific training delivery format. What matters is that training is documented, role appropriate, and effective. Our 21 CFR Part 11 compliant certificates provide verifiable proof of training that EMA, MHRA, and other EU competent authorities accept during inspections.
The Clinical Trials Regulation applies from 31 January 2022, replacing the Clinical Trials Directive (2001/20/EC).
Completion of basic GCP awareness training of at least four hours or equivalent on the job experience, and at least six months of experience in clinical research.
Yes. We offer corporate and group enrollment options for teams of all sizes. Contact us for a custom quote.
All courses include lifetime access — study at your own pace, on your own schedule.
Yes. Each certificate includes a unique verifiable ID that can be checked at gxptrainings.com/verify-certificate/
Equip yourself and your team with the GCP knowledge and documented training records required for Health Canada, FDA, and WHO inspection readiness.