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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): 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: Part 1
  8. Contract Research Organisations: Part 2
  9. Trial Design
  10. Trial Management and Data Processing: Part 1
  11. Trial Management and Data Processing: Part 2
  12. Trial Management and Data Processing: Part 3
  13. Electronic Data Systems
  14. 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 Investigational Medicinal Products (IMPs)
  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 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
course_certificate_icon

Our GCP 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 research professionals with the necessary knowledge and skills to conduct

high-quality clinical trials. This comprehensive course covers the internationally accepted 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 accuracy and reliability of clinical trial data

-Fostering uniform, top-tier practices across all facets of clinical research

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

For those engaged in clinical trial research, obtaining GCP certification is essential.

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

  • Alignment with global standards
  • Boosting the reliability and calibre of research
  • Safeguarding the rights and wellbeing of trial participants
  • Opening up career opportunities in clinical research

Whitehall Training's Good Clinical Practice Course not only provides you with the necessary certification but also imparts practical knowledge for effectively implementing GCP principles in your daily work. This combination of theoretical understanding and hands-on application makes our course particularly valuable for professionals in the field.

A broad spectrum of professionals within clinical research find GCP certification crucial:

  • Lead and Associate Investigators: Those with primary responsibility for overseeing and conducting trials at research facilities.
  • On-site Trial Team: This encompasses research coordinators, study nurses, and additional personnel involved in the day-to-day management of clinical trials.
  • Trial Sponsors and CROs: Individuals responsible for the overall planning, commencement, and documentation of clinical studies.
  • Regulatory Body Representatives: Officials tasked with supervising and assessing trial compliance with established standards.
  • Ethics Committee Members: Professionals who scrutinise and endorse trial protocols to ensure ethical conduct.
  • Staff at Research Institutions: Those ensuring that institutional research aligns with international benchmarks.
  • Researchers Funded by National Health Bodies: All team members engaged in nationally funded clinical trials.

The Whitehall Training Good Clinical Practice Course is tailored to accommodate this varied audience, offering both universal GCP principles and role-specific guidance.

Moreover, the course proves beneficial for individuals aiming to enhance their research capabilities and refine their approach to clinical trial operations.

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 studies and is available in multiple languages.

Crafted by an industry veteran with over three decades of experience, including a tenure as Research Director at a major pharmaceutical company, this course offers in-depth knowledge and practical insights. 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 developed the course with a focus on clarity and visual appeal, making it easy to navigate and understand. The content is structured to allow straightforward cross-referencing with the ICH-GCP E6 document, enhancing its utility as a learning tool.

In addition to English, we offer the course in several other languages, including German, Bulgarian, French, Italian, Japanese, Polish, Portuguese, Russian and Spanish. We've also created region-specific versions tailored to the regulatory frameworks of Australia, the UK, the US, France, Germany and Latin America.

Upon completion, participants can earn 6 CPD points, adding value to their professional development. The course combines theoretical knowledge with practical application, drawing from the author's extensive industry experience to provide a well-rounded understanding of Good Clinical Practice.

Indeed, our GCP course has received certification from the Faculty of Pharmaceutical Medicine at the Royal College of Physicians. This esteemed organisation is the professional body representing pharmaceutical physicians in the United Kingdom and has been establishing stringent research standards since 1989.

The certification of our course by such a respected institution serves as a testament to its quality. It demonstrates that our training meets the exacting standards set by both the industry and academia, providing you with a qualification that is widely acknowledged in the field.

The cost of GCP certification can vary based on several key elements:

  • Official approval: Has the course received accreditation from recognised bodies?
  • International compliance: Does the training meet ICH standards, enabling participation in global clinical trials?
  • Content relevance: 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 comprehensive offering:

  • Recognised accreditation: The Royal College of Physicians has awarded our course 6 CPD points.
  • Global trial readiness: Our training adheres to ICH E6(R2) guidelines, preparing researchers for international clinical trials.
  • Expert-led content: Lucy Parker, our GCP specialist with over 10 years of experience leading research in major institutions like the NHS, has crafted the course material.
  • Unlimited access: We support ongoing professional development by providing lifelong access to course resources.

Are you purchasing for multiple team members? A 10% discount is automatically applied at checkout for orders of 5 licences. For larger group bookings, please contact our team to discuss tailored pricing options.