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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 and meets the training requirement for you to participate in international clinical trials.

Course Syllabus

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

  1. Introduction
  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
  12. Informed Consent of Trial Participants: The Consent Discussion
  13. Informed Consent of Trial Participants: Obtaining Consent Subjects Who Cannot Read or Write
  14. Informed Consent of Trial Participants: Obtaining Consent of Minors and “Mentally Incompetent” Subjects
  15. Informed Consent of Trial Participants: Obtaining Consent and Incapacitated Subjects
  16. Informed Consent of Trial Participants: 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)
  5. Contract Research Organisations
  6. Trial Design
  7. Trial Management and Data Processing: Part 1
  8. Trial Management and Data Processing: Part 2
  9. Trial Management and Data Processing: Part 3
  10. Trial Management and Data Processing: Part 4
  11. Trial Management and Data Processing: Part 5
  12. Investigator Selection: Introduction
  13. Investigator Selection: Permissions
  14. Investigator Selection: Responsibilities
  15. Investigator Selection: Compensation
  16. Financing
  17. Notification/ Submission to Regulatory Authorities
  18. Gaining CA Approval in the EU
  19. Confirmation of Review by IRB/IEC
  20. Information on IMP
  21. Manufacturing, Packaging, Labelling, and Coding Investigational Products: Part 1
  22. Manufacturing, Packaging, Labelling, and Coding Investigational Products: Part 2
  23. Supplying and Handling Investigational Products
  24. Record Access
  25. Audit and Inspection
  26. Noncompliance
  27. Premature Termination or Suspension of a Trial
  28. Clinical Trial/Study Reports
  29. Multicentre Trials

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

  1. Introduction
  2. Adverse Drug Reaction Reports: Part 1 – Adverse Events (AEs)
  3. Adverse Drug Reaction Reports: Part 2 – Serious Adverse Events
  4. Adverse Drug Reaction Reports: Part 3 – Suspected Unexpected Serious Adverse Reactions (SUSARs)
  5. Adverse Drug Reaction Reports: Part 4 – Adverse Events of Special Interest
  6. Adverse Drug Reaction Reports: Part 5 – Periodic Safety Reports
  7. Adverse Drug Reaction Reports: Part 6 – Reporting Decision Tree

  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. 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
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Our GCP certified customers

novartis
NHS
takeda
roche
baxter

Learner Rating & Reviews

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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 those involved in clinical research with the necessary knowledge and skills to conduct trials ethically and scientifically. 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 accuracy and reliability of clinical trial data
  • Fostering uniformity in high-standard practices across all clinical research activities

Whitehall Training's Good Clinical Practice Course thoroughly explores these crucial areas, offering learners a robust grounding in both the theoretical principles and practical applications of GCP. Our course ensures that participants gain a thorough understanding of the ethical and scientific standards essential for executing high-quality clinical trials.

For those aiming to take part in clinical trials research, obtaining GCP certification is essential.

If you're keen to broaden your knowledge of the clinical research field, GCP certification offers significant benefits:

  • It guarantees adherence to global standards
  • Your research gains credibility and quality
  • Study participants' rights and well-being are safeguarded
  • It opens up more career opportunities in clinical research

Whitehall Training's Good Clinical Practice Course doesn't just offer certification; it also provides you with hands-on skills to effectively implement GCP principles in your day-to-day work. This practical approach ensures you're well-prepared for the realities of clinical research, making our course a worthwhile investment for your professional development.

Good Clinical Practice (GCP) certification is crucial for numerous professionals involved in clinical research. The following roles typically require GCP training:

  • Lead Researchers and Co-investigators: Those who oversee and conduct trials at research facilities.
  • On-site Clinical Trial Team: This includes study coordinators, research nurses, and other personnel involved in day-to-day trial operations.
  • Trial Sponsors and Research Organisations: Individuals responsible for trial planning, commencement, and result compilation.
  • Regulatory Body Representatives: Officials tasked with ensuring trials comply with established standards.
  • Ethics Committees and Review Boards: Members who assess and approve trial protocols.
  • University and Research Centre Staff: Those ensuring institutional research meets international benchmarks.
  • Researchers Funded by National Bodies: All staff working on nationally funded clinical studies.

Our Whitehall Training Good Clinical Practice Course is designed to meet the needs of this diverse group, offering both role-specific guidance and fundamental GCP principles.

Moreover, the course is beneficial for anyone seeking to enhance their research capabilities or improve their understanding of clinical trial procedures, regardless of their current role in the field.

Our GCP training programme is a comprehensive guide to the international ICH-GCP (E6-R2) guidelines, essential for anyone involved in clinical trials. It's designed to meet the training requirements for participation in international clinical studies, offering a thorough, step-by-step approach to understanding and implementing Good Clinical Practice.

Crafted by an industry veteran with over three decades of experience, including a stint as Research Director at a major pharmaceutical company, this course brings real-world insights to your learning. The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom has accredited our programme, underscoring its quality and relevance.

We've made accessibility a priority, offering the course in multiple languages beyond English, including German, Bulgarian, French, Italian, Japanese, Polish, Portuguese, Russian, and Spanish. For those working in specific regions, we've developed tailored versions that align with the regulatory frameworks of Australia, the UK, the US, France, Germany, and Latin America.

Our course stands out for its user-friendly design, featuring clear, visually engaging content that's easy to follow. We've structured it to allow simple cross-referencing with the ICH-GCP E6 document, enhancing your understanding of the guidelines. The practical insights woven throughout the course, drawn from extensive industry experience, help bridge the gap between theory and real-world application.

Upon completion, participants can earn 6 CPD points, adding value to their professional development. Whether you're new to clinical trials or looking to refresh your knowledge, our GCP course offers a robust, accredited learning experience to support your role in clinical research.

Indeed, our GCP course has received accreditation from a prestigious body: the Faculty of Pharmaceutical Medicine at the Royal College of Physicians. This institution is renowned as the professional membership organisation for pharmaceutical physicians in the United Kingdom and has been establishing stringent research standards since 1989.

The accreditation of our course by such a respected entity serves as a testament to its quality. It assures participants that the content and delivery meet exacting industry and academic criteria, resulting in a qualification that is widely acknowledged within the field.

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

  • Official recognition: Has the course been endorsed by reputable organisations?
  • International compliance: Does the certification meet ICH standards for global clinical trial participation?
  • Content excellence: Is the material current and authored by industry professionals?
  • Duration of availability: For how long can students access the course materials?

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

  • Official recognition: We've earned accreditation from the Royal College of Physicians, offering 6 CPD points.
  • International compliance: Our certification adheres to ICH E6(R2) guidelines, enabling participation in clinical trials worldwide.
  • Content excellence: The course is crafted by our GCP specialist, Lucy Parker, who brings over ten years of experience managing research across major institutions, including the NHS.
  • Duration of availability: We support continuous learning by providing unlimited access to course resources.

For group bookings, we offer a 10% discount on orders of 5 licences at checkout. If you're interested in larger group discounts, please reach out to our team for a tailored quote.