Comprehensive online GCP training aligned with MHRA requirements, the Medicines for Human Use (Clinical Trials) Regulations 2004, ICH E6(R3), and international standards — trusted by UK clinical research professionals, sponsors, investigators, and CROs. Self paced. 21 CFR Part 11 compliant certificates. Inspection ready training records.
The United Kingdom has a comprehensive regulatory framework for Good Clinical Practice (GCP) that is governed by the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 1031) , which implement the EU Clinical Trials Directive into UK law. The MHRA is the competent authority responsible for the regulation of clinical trials in the UK.
| Market | Framework | Application |
|---|---|---|
| MHRA | Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 1031) | UK implementation of the Clinical Trials Directive |
| MHRA | GCP Inspection Programme | Routine inspections of clinical trial |
| MHRA | ICH E6(R3) GCP | International ethical and scientific quality standard |
| European Union (applicable) | Directives 2001/20/EC and 2005/28/EC | EU GCP framework (applicable where retained) |
All courses are self paced, available online, and include 21 CFR Part 11 compliant certificates with verifiable IDs — accepted as documented training records during 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 UK.
The MHRA conducts GCP inspections of clinical trial sites, sponsors, and CROs to verify compliance with GCP requirements. The MHRA GCP Inspection Programme covers clinical trial sites, sponsors, and CROs. Inspection findings can have serious consequences:
Common MHRA GCP inspection observations include:
Our 21 CFR Part 11 compliant certificates provide auditable, documented training records that MHRA inspectors accept during inspections.
The United Kingdom, through the MHRA, remains an active participant in the international development of Good Clinical Practice standards. Understanding this global context is essential for UK 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 MHRA has adopted this guideline, ensuring that data generated in compliance with ICH E6(R3) is accepted by regulators worldwide, including the FDA and EMA.
The UK has established a robust, independent framework for clinical trials post-Brexit, anchored by the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended) and the MHRA GCP Inspection Programme. Our GCP training programs are aligned with both UK requirements and ICH E6(R3), equipping you to conduct trials that meet the highest UK standards while remaining compliant with global expectations.
Clinical trial data generated in the UK is frequently used to support Marketing Authorisation Applications (MAAs) not only in the UK but also in the EU, US, and other regions. Our GCP courses cover the principles recognized by all major regulatory authorities, including the MHRA, EMA, and FDA, ensuring your clinical data is submission-ready for a global market.
Training your clinical monitors, investigators, quality assurance staff, or auditors? Our programs provide consistent, verifiable training across your organization, ensuring inspection readiness for MHRA GCP audits. Group quotes provided within 24 hours.
| Feature | GxP Trainings |
|---|---|
| Medicines for Human Use (Clinical Trials) Regulations 2004 aligned | |
| MHRA GCP Inspection Programme aligned | |
| ICH E6(R3) GCP aligned | |
| EU Directives 2001/20/EC and 2005/28/EC 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. The MHRA does 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 MHRA inspectors accept during inspections.
The MHRA GCP Inspection Programme ensures that the rights, safety, and well-being of trial subjects are protected, and that clinical trial data are reliable and robust. Inspections are conducted at clinical trial sites, sponsor organisations, and CROs.
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.