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Clinical Practice
Pharmacovigilance
Manufacturing
Laboratory Practice
Distribution
MDR

About

Written by an expert with over 30 years of experience up to the Research Director level in a major pharma group, this GCP training course covers the ICH-GCP (E6-R2) international guidelines, along with the additional policies that are essential for practice in the UK.
Upon completion, learners meets the training requirement to participate in international clinical trials

Course Syllabus

  1. What is GCP
  2. Why is ICH GCP Important
  3. The Principles of ICH GCP
  4. Additional Learning Points
  5. Documentation and Version Control
  6. Quality Assurance (QA)
  7. Key Resources

  1. Introduction: Part 1
  2. Responsibilities of the CA
  3. Responsibilities of the IEC
  4. Subject Informed Consent Forms (ICF): Part 1
  5. Subject Informed Consent Forms (ICF): Part 2
  6. Composition, Functions, Operations, Procedures, and Records

  1. Introduction
  2. Investigator Responsibilities
  3. Investigator Qualifications and Agreements
  4. Adequate Resources
  5. Medical Care of Trial Subjects: Part 1
  6. Medical Care of Trial Subjects: Part 2
  7. Communication with IRB/IEC
  8. Compliance with the Protocol
  9. Investigational Medicinal Products
  10. Randomisation Procedures and Un-blinding
  11. Informed Consent of Trial Participants: Part 1
  12. Informed Consent of Trial Participants: Part 2 - The Debate on Consents
  13. Informed Consent of Trial Participants: Part 3 - Obtaining Consent of Subjects Who Cannot Read or Write
  14. Informed Consent of Trial Participants: Part 4 – Obtaining Consent of Minors and “Mentally Incompetent” Subjects
  15. Informed Consent of Trial Participants: Part 5 – Obtaining Consent: Incapacitated Subjects
  16. Informed Consent of Trial Participants: Part 6 – Updating Consent
  17. Records and Reports: Introduction
  18. Records and Reports: Study Site Files
  19. Records and Reports: Updates & Amendments
  20. Records and Reports: Source Documents
  21. Records and Reports: Financial Information
  22. Records and Reports: The Case Record Form
  23. Records and Reports: Recording Subject Data
  24. Premature Termination or Suspension of a Trial
  25. Progress Reports and Final Reports by Investigator
  26. Archiving

  1. Introduction
  2. Quality Management: Part 1
  3. Quality Management: Part 2
  4. QA and QC (Quality Assurance and Quality Control): Introduction
  5. QA and QC (Quality Assurance and Quality Control): Standard Operating Procedures
  6. QA and QC (Quality Assurance and Quality Control): Agreements & Contracts
  7. Contract Research Organisations
  8. Medical Expertise
  9. Trial Design
  10. Trial Management, Data Management, and Record Keeping: Part 1 – Research Management
  11. Trial Management, Data Management, and Record Keeping: Part 2
  12. Trial Management, Data Management, and Record Keeping: Part 3
  13. Trial Management, Data Management, and Record Keeping: Part 4 – Electronic Data Systems
  14. Trial Management, Data Management, and Record Keeping: Part 5 – Record Keeping
  15. Investigator Selection: Introduction
  16. Investigator Selection: Permissions
  17. Investigator Selection: Responsibilities
  18. Investigator Selection: Compensation
  19. Financing
  20. Notification/ Submission to Regulatory Authorities
  21. Gaining CA Approval in the EU
  22. Confirmation of Review by IRB/IEC
  23. Information on IMP
  24. Manufacturing, Packaging, Labelling, and Coding Investigational Products: Part 1
  25. Manufacturing, Packaging, Labelling, and Coding Investigational Products: Part 2
  26. Supplying and Handling Investigational Products
  27. Record Access
  28. Audit and Inspection
  29. Noncompliance
  30. Premature Termination or Suspension of a Trial
  31. Clinical Trial/Study Reports
  32. Multicentre Trials

  1. Introduction
  2. Monitoring: Part 1
  3. Monitoring: Part 2 – Monitor Responsibilities
  4. Monitoring: Part 3 - The Follow-up Visit
  5. Monitoring: Part 4 – Review of the Investigational Medicinal Product
  6. Monitoring: Part 5 – Complying with the Protocol, Amendments, SOP and Guidance
  7. Monitoring: Part 6 - Verifying Informed Consent
  8. Monitoring: Part 7 - The Case Record Form (CRF) and Source Documents
  9. Monitoring: Part 8 - Verifying Subject Data
  10. Monitoring: Part 9 – Errors
  11. Monitoring: Part 10 – Completion of the Monitoring Visit
  12. The Monitoring Report & Plan
  13. Quality Management - Centralised Monitoring
  14. Fraud and Misconduct

  1. Introduction
  2. Adverse Drug Rection Reports: Part 1 – Adverse Events (AEs)
  3. Adverse Drug Rection Reports: Part 2 – Serious Adverse Events
  4. Adverse Drug Rection Reports: Part 3
  5. Adverse Drug Rection Reports: Part 4 – Adverse Events of Special Interest
  6. Adverse Drug Rection Reports: Part 5 – Periodic Safety Reports
  7. Adverse Drug Rection Reports: Part 6

  1. Introduction
  2. Protocol Structure and Content

  1. Introduction
  2. Investigator Brochure Structure and Content

  1. Introduction
  2. Essential Documents
  3. Archiving
  4. Documents to be Present Pre-Study
  5. Documents to be Present During the Study
  6. Documents to be Present Post-Study

  1. Introduction
  2. Argentina
  3. Brazil
  4. Chile
  5. Colombia
  6. Mexico
  7. Peru

  1. Glossary & Abbreviations
  2. Useful Reference Documents List

Course Certificate

On course completion, you receive your official ICH-GCP e6(R2) certification, allowing you to participate in clinical trials internationally
course_certificate_icon

Our GCP certified customers

novartis
NHS
takeda
roche
baxter

Learner Rating & Reviews

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RC

Working with Whitehall training for the last two years of partnership has been a very successful experience – I have fast access to all the GCP course...

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Frequently Asked Questions

Good Clinical Practice (GCP) training is a vital educational programme designed to equip clinical trial professionals and researchers with the necessary knowledge of ethical and scientific standards essential for conducting top-tier clinical trials. This comprehensive course covers the globally recognised guidelines set forth by the International Council for Harmonisation (ICH).

The core objectives of GCP training include:

  • Safeguarding the rights, safety, and welfare of human participants
  • Upholding the credibility and reliability of clinical trial data
  • Fostering uniform, high-calibre practices across all facets of clinical research

Our Whitehall Training GCP course thoroughly explores these crucial areas, offering learners a robust grounding in both the theoretical principles and practical applications of Good Clinical Practice. By completing this training, participants gain the skills and understanding needed to navigate the complex landscape of clinical trials with confidence and competence.

Absolutely. For anyone looking to engage in clinical trials research, GCP certification is not just valuable—it's essential.

Even if you're simply keen to broaden your knowledge of the clinical research landscape, obtaining GCP certification offers numerous benefits:

  • It demonstrates your commitment to upholding global research standards
  • Your research gains increased credibility and quality
  • You'll be better equipped to safeguard the rights and wellbeing of trial participants
  • Your career prospects in the clinical research sector could significantly improve

Our Whitehall Training Good Clinical Practice Course goes beyond mere certification. We provide you with practical, hands-on skills that enable you to apply GCP principles effectively in real-world scenarios. This comprehensive approach ensures you're not just certified, but truly competent in GCP implementation.

Good Clinical Practice (GCP) training is crucial for a broad spectrum of professionals involved in clinical research. While not everyone in the field requires certification, it's highly beneficial for many roles:

  • Lead Researchers and Their Teams: This includes principal investigators and co-investigators who oversee the conduct of trials at research sites.
  • On-site Clinical Trial Personnel: Research coordinators, study nurses, and other staff members who manage day-to-day trial operations fall into this category.
  • Trial Oversight Professionals: Individuals from sponsoring organisations and Contract Research Organisations (CROs) who plan, initiate, and report on trials.
  • Regulatory Compliance Officers: Those tasked with monitoring and assessing trial compliance with established standards.
  • Ethics Review Committees: Members responsible for scrutinising and approving trial protocols before implementation.
  • University and Research Centre Staff: Employees ensuring that institutional research meets international benchmarks.
  • Publicly Funded Researchers: All investigators and support staff engaged in government-funded clinical trials.

Whitehall Training's Good Clinical Practice Course is designed to address the needs of this diverse audience. It offers role-specific knowledge alongside fundamental GCP principles, making it an excellent choice for both experienced professionals and those new to clinical research who wish to enhance their skills and improve their understanding of clinical trial operations.

Our Good Clinical Practice (GCP) training programme is designed to thoroughly cover the ICH-GCP (E6-R2) international guidelines, ensuring you meet the necessary training requirements for participation in global clinical trials. We offer this comprehensive course in multiple languages to cater to a diverse audience.

This training serves as a contemporary, step-by-step guide to the ICH-GCP (E6-R2) guidelines, making it an indispensable resource for anyone involved in clinical trial management. The course content has been meticulously crafted by an industry veteran with more than three decades of experience, including a tenure as Research Director at a leading pharmaceutical company.

We're proud to offer a course that's received accreditation from the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. In addition to English, you can access the course in a variety of languages including German, Bulgarian, French, Italian, Japanese, Polish, Portuguese, Russian, and Spanish.

To address specific regional needs, we've developed tailored versions of the course that align with the regulatory frameworks of Australia, the UK, the US, France, Germany, and Latin America. These regional adaptations ensure that participants gain relevant, market-specific knowledge.

Our course stands out for its user-friendly, visually engaging format, which facilitates easy reference to the ICH-GCP E6 document. Drawing from the author's wealth of experience, it provides practical insights into the real-world application of GCP principles. As an added benefit, participants can earn 6 CPD points upon completion.

By choosing our GCP course, you're opting for a high-quality, accredited training programme that combines comprehensive content with practical insights, all presented in an accessible format.

Indeed, our GCP course has received certification from a prestigious organisation in the field. The Faculty of Pharmaceutical Medicine, which is part of the Royal College of Physicians, has accredited our course. This institution is well-known in the UK for being the professional body representing pharmaceutical physicians and has been establishing stringent research standards since 1989.

The endorsement from such a respected body serves as a testament to the quality of our course. It assures participants that the content and delivery meet exacting industry and academic benchmarks. When you complete this course, you'll receive a certification that is widely acknowledged within the pharmaceutical and clinical research sectors.

The price of GCP certification can fluctuate based on several key factors:

  • Official recognition: Has the course received approval from respected organisations?
  • International compliance: Does the training fulfil ICH requirements, allowing researchers to engage in global clinical trials?
  • Content quality: Is the material current and authored by industry professionals?
  • Availability: For how long can students access the course materials?

At Whitehall Training, our GCP course is priced at £79, reflecting its high standards across these areas:

  • Recognition: The Royal College of Physicians has accredited our course, awarding 6 CPD points.
  • Global acceptance: Upon completion, researchers are equipped to participate in clinical trials worldwide, in line with ICH E6(R2) guidelines.
  • Expert-led content: Our course material is developed by Lucy Parker, our GCP specialist with over 10 years of experience leading research in major institutions, including the NHS.
  • Ongoing access: We support continuous professional development by offering unlimited access to course resources.

For group bookings, we provide a 10% discount on purchases of 5 licences at checkout. If you're interested in larger group discounts, please contact our team for a tailored quote.