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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. The History of GCP: Part 1
  2. The History of GCP: Part 2
  3. What is GCP?
  4. Introduction to GCP (Mini-Exam)
  5. How was GCP Introduced to the UK
  6. The Principles of ICH GCP
  7. Additional Learning Points
  8. Documentation and Version Control
  9. Quality Assurance (QA)
  10. MHRA GCP Inspections
  11. Key Resources
  12. Introduction to GCP (Webinar)

  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
  6. Communication with IRB/IEC
  7. Compliance with the Protocol
  8. Investigational Medicinal Products (IMPs)
  9. Randomisation Procedures and Un-blinding
  10. Informed Consent of Trial Participants
  11. Informed Consent of Trial Participants: The Consent Discussion
  12. Informed Consent of Trial Participants: Obtaining Consent Subjects Who Cannot Read or Write
  13. Informed Consent of Trial Participants: Obtaining Consent of Minors and “Mentally Incompetent” Subjects
  14. Informed Consent of Trial Participants: Obtaining Consent and Incapacitated Subjects
  15. Informed Consent of Trial Participants: Updating Consent
  16. Records and Reports: Introduction
  17. Records and Reports: Study Site Files
  18. Records and Reports: Updates & Amendments
  19. Records and Reports: Source Documents
  20. Records and Reports: Financial Information
  21. Records and Reports: The Case Record Form (CRF)
  22. Records and Reports: Recording Subject Data
  23. Premature Termination or Suspension of a Trial
  24. Progress Reports and Final Reports by Investigator
  25. Archiving

  1. Introduction
  2. Quality Management: Part 1
  3. Quality Management: Part 2
  4. QA and QC (Quality Assurance and Quality Control): Part 1
  5. QA and QC (Quality Assurance and Quality Control): Part 2 – Standard Operating Procedures (SOPs)
  6. QA and QC (Quality Assurance and Quality Control) – Contracts and Agreements
  7. Contract Research Organisations
  8. Trial Design
  9. Trial Management: Part 1
  10. Trial Management: Part 2 – Data Management
  11. Trial Management: Part 3 – Electronic Data Systems
  12. Trial Management: Part 4 – Record Keeping
  13. Investigator Selection: Introduction
  14. Investigator Selection: Permissions
  15. Investigator Selection: Responsibilities
  16. Investigator Selection: Compensation
  17. Financing
  18. Notification/ Submission to Regulatory Authorities
  19. Gaining CA Approval in the EU
  20. Confirmation of Review by IRB/IEC
  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. Audit and Inspection
  25. Noncompliance
  26. Premature Termination or Suspension of a Trial
  27. Clinical Trial/Study Reports
  28. 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 in CRFs
  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
  3. Adverse Drug Reaction Reports: Part 2 – Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)
  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: Part 1
  3. Protocol Structure and Content: Part 2 – Selection and Withdrawal of Subjects
  4. Treatment of Subjects

  1. Introduction
  2. Table of Contents of Investigator's Brochure (Example)

  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
course_certificate_icon

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 clinical trial professionals and researchers with the essential knowledge of ethical and scientific standards required for conducting top-tier clinical studies. 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 reliability and integrity of clinical trial data
  • Fostering uniform, high-calibre practices across all clinical research domains

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 providing a deep dive into these fundamental aspects, we ensure that participants are well-prepared to navigate the complexities of clinical research while adhering to the highest standards of ethics and scientific rigour.

Absolutely. For those involved in clinical trials, GCP certification isn't just valuable—it's essential. But even if you're not directly participating in trials, obtaining GCP certification can be incredibly beneficial:

  • It demonstrates your commitment to upholding global research standards
  • Your research gains enhanced credibility and quality
  • You'll be well-versed in safeguarding the rights and wellbeing of trial participants
  • It can open doors to exciting career opportunities in clinical research

Our Whitehall Training Good Clinical Practice Course goes beyond mere certification. We provide you with practical, hands-on knowledge that you can immediately apply in your professional life. By mastering GCP principles through our course, you'll be well-equipped to navigate the complexities of clinical research with confidence and expertise.

A broad spectrum of individuals involved in clinical research can benefit from GCP certification:

  • Lead and Co-investigators: Those with primary responsibility for overseeing and conducting trials at research facilities.
  • On-site Clinical Trial Personnel: This encompasses research coordinators, study nurses, and other team members directly involved in managing trial activities.
  • Trial Sponsors and CROs: Professionals who oversee the planning, commencement, and documentation of clinical trials.
  • Regulatory Body Representatives: Individuals tasked with monitoring and assessing trial compliance with established standards.
  • Ethics Committee and IRB Members: Those responsible for reviewing and approving trial protocols to ensure ethical conduct.
  • Staff at Research Institutions and Universities: Individuals ensuring that institutional research aligns with international benchmarks.
  • Researchers Funded by National Health Bodies: All staff and investigators participating in nationally funded clinical trials.

The Whitehall Training Good Clinical Practice Course is designed to accommodate this diverse range of professionals, offering both fundamental GCP principles and role-specific guidance. Moreover, it's an excellent resource for those aiming to enhance their research capabilities and streamline their clinical trial processes.

Our GCP training course is a comprehensive guide to the ICH-GCP (E6-R2) international guidelines, ensuring you meet the requirements for participation in global clinical trials. We offer this essential training in multiple languages to cater to a diverse audience.

Crafted by an industry veteran with over three decades of experience, including a stint as Research Director at a leading pharmaceutical company, our course provides in-depth knowledge of the most recent ICH-GCP (E6-R2) guidelines. It's an indispensable resource for anyone involved in clinical trial management.

The course boasts accreditation from the Faculty of Pharmaceutical Medicine of the Royal College of Physicians in the UK, underscoring its quality and relevance. Beyond English, we've made the course accessible in nine additional languages, including German, French, Italian, and Japanese, among others. We also offer tailored versions that align with specific regulatory frameworks in various countries and regions.

Our training stands out with its user-friendly design, featuring clear visuals that facilitate easy cross-referencing with the ICH-GCP E6 document. Drawing from the author's extensive practical experience, the course offers valuable insights into the real-world application of Good Clinical Practice principles. As an added benefit, participants can earn 6 CPD points upon completion.

By choosing our GCP course, you're investing in a thorough, accredited, and practical learning experience that will equip you with the knowledge and skills needed to excel in the field of clinical research.

Indeed, our Good Clinical Practice (GCP) course has received endorsement from a highly respected institution in the field of pharmaceutical medicine. The Faculty of Pharmaceutical Medicine, which operates under the auspices of the Royal College of Physicians, has given its seal of approval to our training programme.

This endorsement carries significant weight in the industry. The Faculty, established in 1989, has long been recognised as a leading authority in setting and maintaining exacting standards for pharmaceutical research and practice in the United Kingdom. Their backing of our course serves as a testament to its quality and relevance.

By completing our GCP course, you'll earn a certificate that is widely acknowledged within the pharmaceutical and clinical research sectors. This recognition can be a valuable asset in your professional development, demonstrating your commitment to upholding the highest standards in clinical practice.

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

  • Official recognition: Has the course received approval from reputable organisations?
  • International compliance: Does the training meet ICH standards, allowing participation in global clinical trials?
  • Content quality: Is the material current and authored by industry professionals?
  • Duration of access: For how long can learners use the course resources?

Our Whitehall Training GCP course is priced at £79, offering excellent value due to its:

  • Recognition: Accredited by the Royal College of Physicians, awarding 6 CPD points.
  • Global acceptance: Aligns with ICH E6(R2) guidelines, enabling involvement in international clinical trials.
  • Expert-led content: Developed by our GCP specialist, Lucy Parker, who brings over 10 years of experience managing research across major institutions, including the NHS.
  • Lifelong learning: We provide unlimited access to course materials, supporting ongoing professional development.

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