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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. Using the training materials
  2. The History of GCP - pt 1
  3. The History of GCP - pt 2
  4. What is GCP?
  5. Why should we have ICH-GCP? (Mini-exam)
  6. The Principles of ICH GCP
  7. Some General Points
  8. Documentation and Version Control
  9. Quality Assurance
  10. The specifics of GCP in Australia
  11. Other Resources
  12. Introduction to GCP (Webinar)

  1. Introduction
  2. Responsibilities of the CA (TGA)
  3. Responsibility of the HREC
  4. What needs to be checked?
  5. Subject Informed Consent Forms (ICF) I
  6. Subject Informed Consent Forms (ICF) II
  7. 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 I
  6. Medical Care of Trial Subjects II
  7. Communication with HREC/IRB
  8. Compliance with the Protocol
  9. Investigational Medicinal Product
  10. Randomization Procedures and Un-blinding
  11. Informed Consent I
  12. Informed Consent II - Consent Discussion
  13. Informed Consent III - Pregnant Women
  14. Informed Consent IV - Subjects who Cannot Read or Write
  15. Informed Consent V - Children and young people
  16. Informed Consent VI - People in unequal or dependent relationships
  17. Informed Consent VII - Subjects with mental impairment
  18. Informed Consent VIII - Subjects highly dependent on medical care
  19. Informed Consent IX - Subjects who may be involved in illegal activities
  20. Informed Consent X - Aboriginal and Torres Strait Islander peoples
  21. Informed Consent XI - People in other countries
  22. Informed Consent XII - Updating consent
  23. Records and Reports I
  24. Records and Reports II - Study Site Files
  25. Records and Reports III
  26. Records and Reports IV
  27. Records and Reports V - Financial Information and Contracts
  28. Records and Reports VI - The Case Record Form (CRF)
  29. Records and Reports VII - Recording Subject Data
  30. Premature Termination or Suspension of a Trial
  31. Progress Reports and Final Report(s) by Investigator
  32. Archiving

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

  1. Introduction
  2. Monitoring
  3. Monitor Responsibilities
  4. The Monitoring Visit
  5. Verifying IMP
  6. Complying with the Protocol
  7. Verifying Informed Consent
  8. The CRF and Source Documents
  9. Verifying Subject Data
  10. Errors in CRFs
  11. Closing out the Monitoring Visit
  12. The Monitoring Report & Plan
  13. Quality Management - Centralized Monitoring
  14. Fraud and Misconduct

  1. Introduction
  2. Adverse Events (AE)
  3. Adverse Reactions (ARs)/Adverse Drug Reactions (ADR)
  4. Reference Safety Information (RSI)
  5. Safety Critical Adverse Events
  6. Serious Adverse Event (SAE)/Serious Adverse Reaction (SAR)
  7. Significant Safety Issue (SSI)
  8. Suspected Unexpected Serious Adverse (SUSAR)
  9. Unexpected Adverse Reaction (UAR)
  10. Urgent Safety Measure (USM)
  11. Adverse Event Decision Tree
  12. Sponsor Responsibilities I
  13. Sponsor Responsibilities II - SUSAR Reporting
  14. Sponsor Responsibilities III - SSIs & USMs
  15. Sponsor Responsibilities IV - Annual Report
  16. Principal Investigator Responsibilities
  17. HREC Responsibilities
  18. Institution Responsibilities
  19. TGA Responsibilities
  20. Safety Reporting Flowchart

  1. Introduction
  2. Protocol Structure and Content

  1. Introduction
  2. Investigator Brochure Structure and Content

  1. Essential Documents
  2. Archiving
  3. Documents to be Present Pre-Study
  4. Documents to be Added During the Study
  5. Documents to be Added 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 Certified Customers

novartis
NHS
takeda
roche
baxter

Learner Rating & Reviews

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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 high-quality clinical studies. This comprehensive course covers 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 well-being of human participants
  • Upholding the integrity and reliability of clinical trial data
  • Fostering consistent, top-tier practices across all facets of clinical research

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 is meticulously crafted to ensure that participants gain a thorough understanding of these critical concepts, enabling them to apply this knowledge effectively in their professional roles within the clinical research field.

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

However, even if you're simply keen to broaden your knowledge of the clinical research landscape, GCP certification offers significant benefits:

  • It demonstrates your understanding of global research standards
  • It boosts the reliability and calibre of your research endeavours
  • It upholds the rights and wellbeing of trial participants
  • It can open up new career opportunities within clinical research

Our Good Clinical Practice course goes beyond mere certification. It provides you with hands-on, practical knowledge that you can directly apply to your work in the field. By completing our course, you'll gain a comprehensive understanding of GCP principles and how to implement them effectively in real-world scenarios.

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

  • Lead Researchers and Co-investigators: Those directly responsible for overseeing and conducting clinical trials at research facilities.
  • Research Support Teams: This includes study coordinators, clinical research nurses, and other on-site personnel who play a vital role in managing trial operations.
  • Trial Sponsors and Research Organisations: Individuals in charge of planning, initiating, and reporting on clinical trials.
  • Regulatory Bodies: Officials tasked with monitoring and assessing trial compliance with established standards.
  • Ethics Committees and Review Boards: Members who evaluate and approve trial protocols to ensure ethical conduct.
  • University and Research Centre Staff: Those ensuring that institutional research meets international benchmarks.
  • Government-Funded Researchers: All staff and investigators participating in clinical trials supported by government grants.

Our Whitehall Training Good Clinical Practice Course is tailored to address the needs of this diverse group, offering both universal GCP principles and role-specific guidance. It's also an excellent resource for professionals aiming to enhance their research capabilities and streamline their clinical trial processes.

Our GCP training programme thoroughly covers the ICH-GCP (E6-R2) international guidelines, ensuring you meet the necessary requirements to participate in global clinical trials. We've designed this course as a comprehensive, up-to-date guide to these crucial guidelines, making it an essential resource for anyone involved in clinical trial management.

The course content has been crafted by an industry veteran with over three decades of experience, including time as a Research Director in a major pharmaceutical company. This wealth of knowledge translates into practical insights that go beyond mere theoretical understanding.

We're proud to offer this course in multiple languages, including English, German, Bulgarian, French, Italian, Japanese, Polish, Portuguese, Russian, and Spanish. This diversity allows professionals from various linguistic backgrounds to access high-quality GCP training.

One of the standout features of our course is its clear, visually engaging format. We've designed it to facilitate easy cross-referencing with the ICH-GCP E6 document, enhancing your learning experience and practical application of the material.

The course's quality is further validated by its accreditation from the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. Upon completion, participants earn 6 CPD points, contributing to their professional development.

For those requiring region-specific knowledge, we've developed tailored versions of the course that align with the regulatory frameworks in several countries and regions, including Australia, the UK, the US, France, Germany, and Latin America.

By choosing our GCP course, you're not just ticking a box for compliance; you're investing in a rich, practical understanding of Good Clinical Practice that will serve you well throughout your career in clinical research.

Indeed, our Good Clinical Practice (GCP) course has received certification from a prestigious institution. The Faculty of Pharmaceutical Medicine, which operates under the auspices of the Royal College of Physicians, has granted our course its seal of approval. This organisation has been at the forefront of establishing and maintaining exacting standards in pharmaceutical research since its inception in 1989.

The Faculty's endorsement serves as a testament to the quality and rigour of our course content. It assures participants that the training they receive aligns with the most up-to-date industry benchmarks and academic criteria. Consequently, upon completion, you'll obtain a qualification that is well-regarded across the pharmaceutical and clinical research sectors.

This certification underscores our commitment to delivering top-tier education in Good Clinical Practice, ensuring that you're equipped with knowledge that meets the highest professional standards.

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

  1. Official recognition: Has the course received approval from respected industry bodies?
  2. Global acceptance: Does the certification meet international standards, allowing participation in worldwide clinical trials?
  3. Content relevance: Is the material current and developed by industry professionals?
  4. Availability: For how long can students access the course materials?

Our Whitehall Training GCP course is priced at £79, reflecting its high quality and comprehensive offering:

  1. Recognised qualification: The course carries accreditation from the Royal College of Physicians, awarding 6 CPD points.
  2. Internationally accepted: Completion enables participation in clinical trials, in line with ICH E6(R2) guidelines.
  3. Expert-led content: Developed by our GCP specialist, Lucy Parker, who brings over ten years of experience managing research across major institutions, including the NHS.
  4. Unlimited access: We support ongoing professional development by providing lifelong access to course resources.

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