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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. Basic Information
  2. What is GCP?
  3. Why should there be ICH GCP?
  4. IHC GCP Principles
  5. Details of GCP specific to France
  6. Some Basic Approaches
  7. Documentation and Version Control
  8. Quality Assurance (QA)
  9. Other 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
  7. IEC Interactions with Sponsors and Investigators

  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 IEC
  8. Compliance with the Protocol
  9. Investigational Medicinal Products
  10. Randomisation Procedures and Un-blinding
  11. Informed Consent of Subjects to the Tests
  12. Data Collection and Expression of Results
  13. Informed Consent: The Consent Discussion
  14. Informed Consent: Subjects Who Cannot Read or Write
  15. Informed Consent: Minors and “Mentally Incompetent” Subjects
  16. Informed Consent: Incapacitated Subjects
  17. Informed Consent: Updating Consent
  18. Records and Reports: Introduction
  19. Records and Reports: Study Site Files
  20. Records and Reports: Updates & Amendments
  21. Records and Reports: Source Documents
  22. Records and Reports: Financial Information
  23. Records and Reports: The Case Record Form
  24. Records and Reports: Recording Subject Data
  25. Premature Termination or Suspension of a Trial
  26. Progress Reports and Final Reports by Investigator
  27. 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 Reports
  9. Trial Design
  10. Trial Management
  11. R2 Modifications
  12. Electronic Data Systems
  13. Record Keeping
  14. Investigator Selection: Introduction
  15. Investigator Selection: Permissions
  16. Investigator Selection: Responsibilities
  17. Investigator Selection: Compensation
  18. Financing
  19. Notification/ Submission to Regulatory Authorities
  20. Gaining CA Approval in the EU: Part 1
  21. Gaining CA Approval in the EU: Part 2
  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: Introduction
  3. Monitoring: Monitor Responsibilities
  4. Monitoring: IMP Inspection
  5. Complying with the Protocol, Amendments, SOP and Guidance
  6. Verifying Informed Consent
  7. The Case Record Form (CRF) and Source Documents
  8. Verifying Subject Data
  9. Errors in Subject Data Recording Notebooks
  10. Closing out the Monitoring Visit
  11. The Monitoring Report & Plan
  12. Quality Management - Centralised Monitoring
  13. Fraud and Misconduct

  1. Introduction
  2. Reporting Adverse Drug Reactions: Adverse Events
  3. Reporting Adverse Drug Reactions: Serious Adverse Events
  4. Adverse Drug Reaction Reports
  5. Adverse Reactions of Special Events
  6. Periodic Safety Reports
  7. Reporting of Adverse Drug Reactions

  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. Further Resources

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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I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...

Frequently Asked Questions

Good Clinical Practice (GCP) training is a vital educational programme for those involved in clinical research. It provides essential knowledge about the ethical and scientific standards required to conduct high-quality clinical trials. This comprehensive training is based on the globally recognised guidelines set forth by the International Council for Harmonisation (ICH).

The key objectives of GCP training include:

  • Safeguarding the rights, safety, and welfare of human participants

  • Upholding the accuracy and reliability of clinical trial data

  • Fostering uniform, high-standard practices throughout all stages of clinical research

Whitehall Training's Good Clinical Practice Course thoroughly explores these crucial areas, offering participants a robust understanding of GCP principles and their practical implementation in clinical trials. Our course ensures that learners are well-equipped to navigate the complexities of modern clinical research whilst adhering to international standards.

Absolutely. For those involved in clinical trials, GCP certification isn't just valuable—it's essential.

Even if you're not directly conducting trials but want to deepen your understanding of clinical research, GCP certification offers significant benefits:

  • It demonstrates your commitment to upholding global standards

  • It bolsters the integrity and calibre of your research

  • It shows your dedication to safeguarding participants' wellbeing and rights

  • It can open doors to new opportunities in the clinical research field

Our Good Clinical Practice course goes beyond mere certification. It equips you with practical know-how to implement GCP principles effectively in real-world scenarios. This hands-on approach ensures you're not just certified, but truly prepared to excel in the realm of clinical research.

Good Clinical Practice (GCP) certification is crucial for a broad spectrum of individuals involved in clinical research:

  • Lead Researchers and Their Teams: This includes principal investigators and co-investigators who are accountable for the execution of clinical trials at research facilities.

  • On-site Clinical Trial Personnel: Encompassing research coordinators, clinical nurses, and other staff members who play a role in managing the day-to-day aspects of trials.

  • Trial Overseers and Outsourced Research Firms: Those responsible for the strategic planning, commencement, and documentation of clinical trials.

  • Regulatory Bodies: Officials tasked with supervising and assessing compliance within clinical trials.

  • Ethics Review Boards: Individuals who scrutinise and endorse trial protocols to ensure ethical standards are met.

  • University and Research Centre Employees: Staff ensuring that institutional research aligns with international benchmarks.

  • Researchers Funded by National Health Bodies: All investigators and support staff engaged in publicly funded clinical studies.

Our Whitehall Training Good Clinical Practice Course is designed to accommodate this wide-ranging audience. It offers tailored insights for various roles while covering the fundamental principles of GCP. Moreover, the course serves as an excellent resource for anyone aiming to enhance their research capabilities and refine their clinical trial operations.

Our GCP training programme is a comprehensive guide to the international ICH-GCP (E6-R2) guidelines, designed to fulfil the training requirements for participation in global clinical trials. This course serves as an essential resource for anyone involved in clinical trial management, offering a detailed, step-by-step approach to understanding and implementing Good Clinical Practice.

Crafted by an industry veteran with over three decades of experience, including a tenure as Research Director at a leading pharmaceutical company, our course delivers unparalleled expertise. The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom has accredited this programme, underscoring its quality and relevance.

We've prioritised accessibility by offering the course in multiple languages, including English, German, Bulgarian, French, Italian, Japanese, Polish, Portuguese, Russian, and Spanish. Additionally, we provide region-specific versions tailored to the regulatory landscapes of Australia, the UK, the US, France, Germany, and Latin America.

Our course stands out for its user-friendly design, featuring a visually engaging format that facilitates easy navigation and cross-referencing with the ICH-GCP E6 document. Drawing on the author's wealth of practical experience, it offers valuable insights into the real-world application of GCP principles.

Upon completion, participants can earn 6 CPD points, further enhancing their professional development. Whether you're new to clinical trials or seeking to refresh your knowledge, our GCP course provides the comprehensive training needed to excel in this critical field.

Indeed, our GCP course has received certification from a prestigious body. The Faculty of Pharmaceutical Medicine at the Royal College of Physicians has awarded our course their seal of approval. This organisation is renowned in the UK as the professional membership body for pharmaceutical physicians and has been establishing stringent research standards since 1989.

This certification is a testament to the quality of our course. It demonstrates that our programme meets the exacting standards set by both industry professionals and academic experts. By completing this course, you'll gain a qualification that is widely acknowledged and respected throughout the pharmaceutical and clinical research sectors.

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

  • Official recognition: Has the course received approval from reputable organisations?

  • International compliance: Does the training meet ICH standards, allowing researchers to engage in global clinical trials?

  • 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-quality features:

  • Recognised excellence: The Royal College of Physicians has accredited our course, awarding it 6 CPD points.

  • Global standard compliance: Upon completion, participants are equipped to conduct clinical trials in line with ICH E6(R2) guidelines.

  • Expert-crafted content: Our GCP specialist, Lucy Parker, who boasts over ten years of experience leading research in major institutions like the NHS, has developed the course material.

  • Ongoing access: We support continuous professional development by offering unlimited access to course resources.

For group enrolments, we provide a 10% discount on purchases of 5 licences at checkout. If you're interested in larger group bookings, please contact our team to discuss bespoke pricing options.