Recent research reveals that over 60% of clinical trials in the UK face significant delays due to the stringent requirements from the Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committees (RECs). These setbacks are often driven by complex approval procedures, heightened data transparency expectations, and rigorous documentation requirements. Additionally, many clinical researchers struggle to adapt their trial protocols to comply with the evolving Good Clinical Practice (GCP) standards, driving up costs and prolonging timelines.
This certified program is designed to provide you with a comprehensive understanding of the UK’s clinical trial regulatory framework and equip you with the skills to manage trials effectively in this environment. You will explore the end-to-end trial lifecycle, including the MHRA Clinical Trial Authorization process, REC reviews, and the NHS research governance requirements. In addition, you will explore the full clinical trial lifecycle from protocol design and site initiation to monitoring, data management, pharmacovigilance, adverse event reporting and study closure while ensuring legal and ethical compliance surrounding informed consent, participant safety, and data integrity.
Beyond compliance, this program emphasizes operational excellence in clinical trial delivery. You will develop advanced project management strategies to anticipate and mitigate trial delays, streamline ethics and governance approvals, and optimize patient recruitment across NHS networks. Through practical simulations, you will master stakeholder alignment across sponsors, CROs, investigators, and regulatory authorities, while integrating validated digital systems to strengthen audit readiness and real-time data oversight. By the end of this program, you will acquire the technical depth and managerial expertise required to design, oversee, and execute complex UK clinical trials — ensuring full regulatory compliance, operational efficiency, and uncompromising scientific integrity.
Upon successful completion of the program, you will attain Certified UK Clinical Trials Project Manager (CCT™) designation. This industry-recognized certification will validate your professional credential to lead and manage complex clinical trials in compliance with UK regulatory frameworks and ICH-GCP (R3) standards, positioning you as an expert in leading ethical and compliant clinical trial projects.
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This program will entitle you:
Pricing & Registration- Experience a 3-day instructor-led live program and gain an in-depth understanding of the UK’s clinical trial regulatory frameworks, including MHRA and HRA requirements, NHS Research Governance, and ICH-GCP (R3) standards, ensuring compliance with evolving post-Brexit and international regulations.
- Attain the industry-recognized Certified UK Clinical Trials Project Manager (CCT™), demonstrating your comprehensive expertise across the full clinical trial lifecycle in the UK—from protocol development and Clinical Trial Authorisation (CTA) submissions to vendor and site oversight, risk-based quality management (RBQM), monitoring strategies, and inspection readiness in alignment with MHRA standards.
- Gain practical knowledge in ethical approvals, informed consent processes, data management, pharmacovigilance, and Trial Master File (TMF) maintenance, while strengthening stakeholder coordination, documentation integrity, and quality systems to ensure ethical, compliant, and high-performing clinical research operations across the UK.
- For inquiries, chat with our Program Advisers 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
Accreditations
This Certified UK Clinical Trials Project Manager (CCT™) is a mark of excellence and distinction that signifies a fully qualified expert possesses profound expertise in applying UK regulatory frameworks to optimize trial efficiency, ensure patient safety, and maintain compliance across UK’s complex clinical research landscape. It is accredited by the Chartered Institute of Professional Certifications, which maintains the governing standards for all members. The CCT™ charter is a trademarked charter available only to professionals who have completed and passed this program. The certification is governed and maintained by Chartered Institute of Professional Certifications with over 90,000 members around the world. It is also endorsed by prominent associations and organizations worldwide.
The content of this program has been fully certified and accredited by CPD as adhering to Continuing Professional Principles.
What Can You Expect From This Live Program
UK clinical trials project management is highly complex due to multifaceted challenges like recruitment, regulatory approvals, and resource coordination. On average, pharmaceutical-led projects face 102 days for R&D approvals, 90 days for ethics, and 83 days for regulatory clearance, significantly slowing trial initiation. Additionally, 45% of multicenter trials fail to recruit 80% of target participants on time, leading to costly delays. Managing numerous stakeholders across diverse sites and adhering to stringent regulations adds significant operational complexity in UK trials.
This certified program is designed to equip you with robust, end-to-end knowledge of clinical trial project management within the UK’s regulatory ecosystem. You will gain a comprehensive understanding of UK Clinical Trials Regulation, MHRA and HRA requirements, the Clinical Trial Authorisation (CTA) process, and Combined Review submissions through the Integrated Research Application System (IRAS). You will explore the full trial lifecycle from protocol design and site initiation to monitoring, data management, pharmacovigilance, and study closure ensuring compliance with both national and international standards.
Through practical case studies and interactive sessions, you will develop the ability to apply Quality-by-Design principles, conduct effective risk-based quality management (RBQM), and oversee vendors, CROs, and research sites with measurable KPIs. The program also covers critical competencies in ethical approvals, informed consent (including e-Consent for vulnerable populations), safety reporting under E2 and E19, and maintaining inspection readiness through strong documentation practices, including the Trial Master File (TMF) and Good Documentation Practices (GDP).
Beyond regulatory compliance, you will develop proven clinical trial project management strategies to anticipate and mitigate trial delays, accelerate ethics and governance approvals, and optimize patient recruitment across NHS networks. Through real world case studies and practical applications, you will master stakeholder alignment across sponsors, CROs, investigators, and regulatory authorities, while integrating validated digital systems to strengthen audit readiness and real-time data oversight.
Upon successful completion, you will attain the Certified UK Clinical Trials Project Manager (CCT™) designation, a globally recognized certification that validates your professional competence to lead, manage, and oversee complex clinical trials in compliance with MHRA, HRA, and ICH-GCP (R3) standards. This industry-recognized certification has lifelong validity and positions you as a trusted leader in the UK clinical research and project management.
Key Skills You Will Gain
- Clinical Trial Project Planning
- ICH-GCP (R2/R3) Compliance
- MHRA & HRA Regulatory Navigation
- Clinical Trial Authorisation (CTA) Management
- NHS Research Governance Application
- Ethical Approval & Informed Consent Management
- Protocol Design & Amendment Control
- Quality-by-Design (QbD) Implementation
- Risk-Based Quality Management (RBQM)
- Vendor & CRO Oversight
- Site Selection & Performance Monitoring
- Budgeting & Resource Allocation
- Contract Negotiation & Management
- Data Integrity & ALCOA++ Principles
- Electronic Data Capture (EDC) Oversight
- Pharmacovigilance & Safety Reporting (AE/SAE/SUSAR)
- Development Safety Update Report (DSUR) Preparation
- Inspection Readiness
- CAPA Management
- Trial Master File (TMF) & Documentation Control
- Good Documentation Practices (GDP)
- Remote & Centralized Monitoring Techniques
- Change Control & Issue Escalation
- Stakeholder & Cross-Functional Communication
- Risk Assessment & Mitigation Strategies
- Compliance with GDPR & Data Privacy Laws
- Clinical Study Report (CSR)
- Lay Summary Development
- Post-Trial Transparency
- Disclosure Management
- Application of Digital Tools for Trials
- e-Consent Systems in Clinical trials
- Hybrid Trial Implementation
- Future-Ready Trial Design
Your Faculty Director
Fiona Wallace is an accomplished clinical research leader and educator with over 25 years of global experience spanning CROs and pharmaceutical organizations across multiple continents. As Director of FW Clinical Research, she has successfully led Phase I–IV clinical trial studies across multiple disciplines, bringing deep operational insight into every stage of the clinical trial process.
Renowned for her engaging and practical teaching style, Fiona designs high-impact learning solutions that drive workforce engagement, retention, and regulatory excellence. Her expertise covers clinical monitoring, project management, global clinical regulatory training, and inspection readiness, with a strong focus on GCP compliance, data integrity, and patient safety.
A respected Board Member of The Institute of Clinical Research (ICR), Fiona actively collaborates with UK universities to inspire the next generation of life science professionals. Her mission is to cultivate excellence, resilience, and ethical integrity across the global clinical research community.
Certified UK Clinical Trials Project Manager (CCT™) Program Agenda
Chartered Exam
At the end of the program, there will be a Chartered exam comprised of 50 multiple choice questions. Upon passing the exam, you will be accredited with Certified UK Clinical Trials Project Manager (CCT™) designation.
- 98% of students who have taken this exam have passed the exam successfully. Almost all professionals who have taken our courses have passed this exam and attain their Certified UK Clinical Trials Project Manager (CCT™) designation.
- The exam has 50 multiple choice questions and you need to answer 25 out of 50 questions correctly to pass the exam.
- You can re-take the exam online as many times as you want, with no additional charges for retaking of exams.
- The program cost already includes the exam fees, so there are no additional charges for taking the exam.
- If you have challenges passing the exam, you can secure assistance from our team and faculty leader to help you pass the exam.
Certified UK Clinical Trials Project Manager (CCT™) Designation
Upon completing the program and passing the Chartered exam, you will be awarded with the Certified UK Clinical Trials Project Manager (CCT™) designation that can be used in your resume, CV and other professional credentials. This certification is industry-recognized with lifelong validity.
Globally demanded and recognized, this certification demonstrates your expertise in navigating the UK’s complex clinical trial regulatory landscape. It equips you the expertise to manage trial operations, ensure GCP compliance, and uphold the highest standards of ethics, safety, and data integrity. Developed by Chartered Institute of Professional Certifications, the content of this program has been independently accredited by CPD Certification Service as adhering to the highest standards of continuing professional principles.
Pricing & Registration
United Kingdom
Dates: 15 - 17 Jun 2026
Venue: Online Executive Program (via Zoom)
Time: 9:00am - 4:30pm British Summer Time (BST)
| Early Bird Packages | Regular Pricing | ||
|---|---|---|---|
| By 07 Apr 2026 | By 19 May 2026 | After 19 May 2026 | |
| UK Delegates | GBP 1,495 | GBP 1,695 | GBP 1,795 |
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
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Certified UK Clinical Trials Project Manager (CCT™)
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