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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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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 ethical and scientific knowledge to conduct high-quality trials. This comprehensive course covers the globally acknowledged 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 information
  • Fostering uniformly high standards across all facets of clinical research

The Whitehall Training Good Clinical Practice Course thoroughly explores these crucial areas, offering participants a robust understanding of both the theoretical principles and practical implementation of Good Clinical Practice.

For those aiming to engage in clinical trial research, obtaining GCP certification is essential.

If you're keen to broaden your knowledge in this field, a GCP certification offers significant advantages:

  • Guarantees adherence to global standards
  • Boosts the reliability and calibre of research
  • Safeguards the rights and well-being of participants
  • Enhances career opportunities within clinical research

The Whitehall Training Good Clinical Practice Course not only provides you with certification but also imparts practical knowledge, enabling you to effectively implement GCP principles in your professional endeavours.

Good Clinical Practice (GCP) certification is crucial for numerous roles within the clinical research field:

  • Lead and Assistant Investigators: Those with primary responsibility for overseeing and conducting clinical trials at research locations.
  • On-site Trial Team: This includes research assistants, clinical nurses, and other personnel directly involved in managing trial activities.
  • Trial Organisers and Research Firms: Individuals responsible for the planning, commencement, and documentation of clinical trials.
  • Regulatory Bodies: Officials tasked with ensuring trials comply with established protocols and regulations.
  • Ethics Committees and Review Boards: Groups charged with examining and authorising trial methodologies.
  • Research Institution Personnel: Staff members ensuring that institutional research adheres to global standards.
  • Researchers Funded by National Health Bodies: All staff and investigators participating in clinical trials supported by national health organisations.

Our Whitehall Training Good Clinical Practice Course is designed to accommodate this broad spectrum of professionals, offering both universal GCP principles and role-specific guidance.

The course is also beneficial for individuals seeking to enhance their research capabilities and streamline their clinical trial processes.

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

This course serves as a contemporary, step-by-step guide to the ICH-GCP (E6-R2) guidelines, making it an indispensable resource for anyone involved in clinical trial operations. The content has been meticulously crafted by an industry veteran with over three decades of experience, including a stint as Research Director at a leading pharmaceutical company.

We're proud to have received accreditation from the Faculty of Pharmaceutical Medicine of the Royal College of Physicians in the UK, underscoring the quality and relevance of our course material. To accommodate our international learners, we've made the course available in ten languages, including English, German, Bulgarian, French, Italian, Japanese, Polish, Portuguese, Russian and Spanish.

Understanding the importance of regional regulatory frameworks, we've also developed tailored versions of this course for Australia, the UK, the US, France, Germany and Latin America. These localised editions ensure that participants receive training that's directly applicable to their specific regulatory environment.

Our course boasts a user-friendly, visually engaging format that facilitates easy referencing with the ICH-GCP E6 document. Drawing from the author's extensive industry experience, it offers practical insights into the real-world application of GCP principles. As an added benefit, successful completion of the course awards participants 6 CPD points, supporting ongoing professional development in the field of clinical research.

Indeed, our GCP course has received certification from a highly respected body in the field. 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 for pharmaceutical research since its inception in 1989.

By achieving this certification, we can assure you that our course content aligns with the most current and stringent industry benchmarks. When you complete this course, you'll receive a qualification that is well-regarded throughout the pharmaceutical and clinical research sectors.

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

  • Official recognition: Has the course been endorsed by respected organisations?
  • International validity: Does the certification meet ICH standards, allowing 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?

Our Good Clinical Practice course at Whitehall Training is priced at £79, reflecting its high value:

  • Recognition: We're proud to be accredited by the Royal College of Physicians, offering 6 CPD points.
  • Global acceptance: Our certification adheres to ICH E6(R2) guidelines, enabling participation in international clinical trials.
  • Expert-led content: The course is crafted by our GCP specialist, Lucy Parker, who brings over 10 years of experience managing research across major institutions like the NHS.
  • Lifelong access: We support continuous learning by providing unlimited access to course resources.

Looking to certify a group? We offer a 10% discount when purchasing 5 licences at checkout. For larger team orders, please contact our staff to discuss further savings.