The UK’s clinical trial regulations are among the most intricate in the world—navigating the clinical trial landscape requires authorization from the Medicines and Healthcare products Regulatory Agency (MHRA), approval from a Research Ethics Committee (REC), and strict compliance to evolving post-Brexit legislation. Additionally, the UK places rigorous emphasis on patient safety, informed consent, data protection under the UK GDPR, and pharmacovigilance standards. Statistics show that over 68% of clinical trial sponsors in the UK encounter clinical trial delays due to dual regulatory processes and heightened scrutiny of trial protocols for safety compliance.
This certified program is designed to provide you with a comprehensive understanding of these complex regulations and equip you with the skills to successfully navigate the challenges of clinical trial management in the UK. You will gain expertise across a broad spectrum of critical areas, including the UK Medicines for Human Use (Clinical Trials) Regulations, the latest MHRA guidelines, Good Clinical Practice (GCP) compliance requirements, and the evolving impact of the Medicines and Medical Devices Act 2021. The program will also delve into the critical processes for trial authorization, subject protection, informed consent documentation standards, and pharmacovigilance obligations, alongside transparency initiatives, public registry submissions, and the implications of technological advancements on trial management in the UK.
Moreover, this program will provide you with practical strategies to integrate these regulations into your clinical trial operations, ensuring full compliance while maintaining efficiency and ethical rigor. You will learn how to navigate the complexities of trial design under UK-specific frameworks, address challenges arising from multi-site trial coordination, manage regulatory inspections, and build robust audit trails for computerized systems in compliance with MHRA and UK GDPR standards. Throughout the program, you will develop the capabilities to adapt to the evolving regulatory environment, manage post-authorization trial modifications, and mitigate operational risks associated with non-compliance. By the end of the program, you will be fully equipped to lead compliant, ethical, and efficient clinical trials across the UK’s dynamic research landscape.
Upon successful completion, you will attain the Certification in UK Clinical Trial Regulations and Compliance. This certification holds lifelong validity and not only enhances your professional profile but also demonstrates your expertise in navigating the UK’s complex clinical trial landscape. Globally recognized and industry-respected, the certification holds lifelong validity and will elevate your professional standing, opening new opportunities for leadership roles within the clinical research and pharmaceutical sectors.
1 Chartered Institute of Professional Certifications' reviews and ratings are a comprehensive collection of participants feedback we have gathered over the last decade. To view authentic and personal testimonials that are handwritten by our participants, please download our participants' written reviews here.
This program will entitle you:
Download Brochure Pricing & Registration- Experience 2 days of instructor-led live training and acquire in-depth insights into the UK’s clinical trial regulations, covering the full spectrum of compliance from trial design and approvals to conduct, monitoring, and closeout.
- Attain the industry-recognized Certification in UK Clinical Trial Regulations and Compliance, demonstrating your comprehensive expertise in navigating the regulatory landscape governing the clinical trial process from preparation and submission to approval, reporting, and compliance measures.
- Master essential knowledge in trial design, regulatory compliance, and GCP principles, while gaining strategic insights into ethical approvals, data integrity, risk-based monitoring, and quality management.
- For inquiries, chat with our Program Advisers at advisor@charteredcertifications.com or call us at
- USA: +1 888 745 8875
- Singapore and Asia Pacific: +65 6716 9980
- Australia and New Zealand: +61 3 9909 7310
- UK, Europe and Middle East: +44 (020) 335 57898
Accreditations
This program is accredited by the Chartered Institute of Professional Certifications, which maintains the governing standards for all professionals who have completed this program.
The content of this program has been fully certified and accredited by CPD Certification Service as conforming to Continuing Professional Principles. CPD is the leading independent CPD accreditation institution operating across industry sectors to complement the Continuing Professional Development policies of professional institutes and academic bodies. The CPD Certification Service provides support, advice and recognized independent CPD accreditation compatible with global CPD principles.
What Can You Expect From This Live Program
The UK’s clinical trial environment ranks among the most advanced yet complex globally, shaped by layered regulatory frameworks, evolving ethical standards, and post-Brexit divergence from the EU Clinical Trials Regulation (CTR). Frequent updates to MHRA guidance, shifting expectations on GCP compliance, and differences in governance procedures across England, Scotland, Wales, and Northern Ireland create significant challenges for trial sponsors, investigators, and research professionals striving to maintain regulatory alignment while operating efficiently across the UK.
This certified program will equip you with a comprehensive understanding of the UK’s clinical trial regulations and compliance requirements across all trial phases. You will explore a wide range of essential topics, including the Medicines for Human Use (Clinical Trials) Regulations 2004, Human Medicines Regulations 2012, the UK Clinical Trial Regulation Reform 2024, and regulatory obligations under UK GDPR. The program covers trial submissions, informed consent, ethics approvals via the UK Health Research Authority (HRA) and Research Ethics Committees (RECs), and compliance with MHRA expectations for sponsor oversight, documentation, safety reporting, and GCP adherence. It also highlights regulatory differences across the UK’s devolved administrations.
Throughout the program, you will gain the knowledge and skills to plan, manage, monitor, and close out clinical trials in full compliance with UK regulations. You will learn how to apply current GCP principles, interpret MHRA guidance updates, and implement best practices in risk-based monitoring, data integrity, and audit readiness. Additionally, the program offers hands-on insight into managing Trial Master Files (TMFs), developing Corrective and Preventive Action (CAPAs), responding to inspection findings, and maintaining high-quality documentation to meet MHRA inspection standards.
Moreover, this program provides practical guidance on emerging challenges such as digital and decentralized trial models, AI-driven protocol designs, and integrating real-world evidence while maintaining data privacy and ethical integrity. You will also explore compliance needs for vulnerable populations, diversity in recruitment, and cross-border collaboration post-Brexit.
Upon successfully completing the program, you will earn the Certification in UK Clinical Trial Regulations and Compliance. This certification will validate your ability to navigate the UK’s regulatory landscape and execute compliant, ethical, and high-quality clinical trials. Globally recognized and valid for life, this credential enhances your professional credibility and demonstrates your readiness to lead clinical research projects across commercial, academic, and non-commercial settings.
Key Skills You Will Gain
- UK Clinical Trial Regulation 2004
- Human Medicines Regulation 2012
- MHRA Compliance
- GCP Principles Application
- Informed Consent Management
- HRA/REC Ethics Submissions
- CTA Submission Process
- Sponsor Oversight Planning
- Vendor Management
- Trial Master File (TMF) Management
- Corrective and Preventive Actions (CAPA)
- MHRA Inspection Readiness
- Risk-Based Monitoring (RBM)
- Data Integrity ALCOA+
- Adverse Event Reporting
- GDPR-Compliant Data Handling
- Protocol Compliance Management
- Cross-Border Trial Governance
- Real-World Evidence Integration
- Decentralized Trial Execution
- AI-Enabled Trial Design
- Quality Management Systems (QMS)
- Documentation Standards
- Trial Closeout Procedures
- Stakeholder Communication
- Multi-Site Trial Coordination
- Ethical Risk Mitigation
- Participant Diversity Planning
- Regulatory Risk Assessment
- Post-Brexit Regulatory Navigation
Your Faculty Director
Charlotte Chadwick is an esteemed expert in clinical research and regulatory compliance, bringing over 25 years of leadership across pharmaceutical companies, CROs, and clinical research sites. With deep specialization in UK clinical trial regulations, early phase trials, and MHRA inspection readiness, she has guided numerous organizations through complex regulatory frameworks with precision and confidence.
Charlotte has played a pivotal role in supporting multiple first-time and routine MHRA inspections, consistently achieving 100% compliance. Her technical expertise covers GCP implementation, SOP development, sponsor oversight, ethics and regulatory submissions, and documentation systems. As the founder of her own consultancy, she advises biotech firms, CROs, pharmaceutical companies, and clinical technology providers on inspection-readiness, compliance strategies, and operational optimization.
An accomplished educator, Charlotte has over 15 years of experience delivering impactful training programs on clinical operations and regulatory compliance. She is known for transforming complex regulatory topics into practical, engaging sessions using real-world case studies, scenario-based learning, and visual storytelling. Her workshops and CRA training modules are highly acclaimed for their clarity, relevance, and immediate applicability, empowering professionals to maintain the highest standards of ethical and regulatory conduct in clinical research.
Certified UK Clinical Trial Regulations and Compliance Program Agenda
How You Will Benefit From This Program
- Master the UK Clinical Trials Compliance Framework: Gain a comprehensive understanding of the UK’s regulatory landscape, including the Medicines for Human Use Regulations, Human Medicines Regulations, and UK Clinical Trial Regulation Reform 2024.
- Design and Manage Compliant Clinical Trials: Learn to apply GCP principles, structure compliant trial protocols, and manage operational workflows aligned with MHRA expectations across all phases of clinical research.
- Ensure Inspection-Ready Trial Documentation: Understand the structure, maintenance, and quality control processes of the Trial Master File (TMF), including essential documents required for MHRA inspections.
- Implement Effective Sponsor Oversight Systems: Explore best practices for vendor management, delegation of responsibilities, oversight plans, and regulatory compliance across sponsor-led and outsourced trials.
- Maintain Data Integrity and Compliance: Learn how to manage electronic systems, and maintain audit trails in accordance with GCP and UK GDPR requirements.
- Conduct Protocol Compliance and CAPA Management: Apply practical strategies for identifying protocol deviations, conducting root cause analysis, and implementing Corrective and Preventive Actions (CAPA).
- Integrate Risk-Based Monitoring Strategies: Understand how to conduct risk assessments, prioritize monitoring activities, and apply MHRA-aligned risk-based monitoring plans to optimize trial efficiency.
- Navigate Ethical Approval and Consent Processes: Gain insights into REC/HRA submission pathways, informed consent design, version control, and ethical considerations for diverse and vulnerable populations.
- Develop High-Quality Clinical Trial Documentation: Master the creation and maintenance of compliant trial protocols, investigator brochures, SOPs, and submission packages essential for regulatory approval and inspection readiness.
Certification in UK Clinical Trial Regulations and Compliance
Upon successfully attending this program, you will be awarded with the Certification in UK Clinical Trial Regulations and Compliance that can be used in your resume, CV and other professional credentials. This certification is industry-recognized with lifelong validity.
Globally respected and in high demand, this certification will amplify your expertise in conducting ethical, efficient, and fully compliant clinical trials in accordance with the UK’s latest regulatory frameworks and MHRA expectations. It validates your capability to develop and implement robust clinical trial compliance systems aligned with UK legislation, GCP standards, and international best practices. This program is developed by Chartered Institute of Professional Certifications and the content of this program has been certified by CPD Certification Service as adhering to highest standards of continuing professional principles.
Pricing & Registration
United Kingdom
Dates: 27 - 28 Jan 2026
Venue: Online Executive Program (via Zoom)
Time: 9:00am - 4:30pm Greenwich Mean Time (GMT)
| Early Bird Packages | Regular Pricing | ||
|---|---|---|---|
| By 10 Nov 2025 | By 22 Dec 2025 | After 22 Dec 2025 | |
| UK Delegates | GBP 1,095 | GBP 1,295 | GBP 1,395 |
Group Discount: 2nd participant get 10%, or register 3 participants and 4th participant get a complimentary seat (1 discount scheme applies)
Register NowDownload Brochure
You can download our program brochure below. If you have any inquiries on this program, please contact our Program Advisor at advisor@charteredcertifications.com or call us at:
- Singapore and Asia Pacific: +65 6716 9980
- Australia and New Zealand: +61 3 9909 7310
- UK, Europe and Middle East: +44 (020) 335 57898
- USA: +1 888 745 8875
Convincing Your Boss To Attend This Program
Securing approval from your boss to attend this program can be difficult if you don’t know what to say. So we’ve prepared a template for you! All you need to do is to download this template, copy and paste in email and send it to your boss!
Certified UK Clinical Trial Regulations and Compliance
4.6 (919 ratings)