ICH GCP R3 is now in English & EU languages. Book Now
  • Clinical PracticeClinical PracticeRight Arrow
  • PharmacovigilancePharmacovigilanceRight Arrow
  • ManufacturingManufacturingRight Arrow
  • Laboratory PracticeLaboratory PracticeRight Arrow
  • DistributionDistributionRight Arrow
  • MDRMDRRight Arrow
  • AI ClinicalAI ClinicalRight Arrow
Clinical Practice
Pharmacovigilance
Manufacturing
Laboratory Practice
Distribution
MDR
AI Clinical

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 should there be ICH GCP?
  4. ICH GCP Principles
  5. Some Basic Approaches
  6. Documentation and Version Control
  7. Quality Assurance (QA)
  8. 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

  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: Introduction
  12. Informed Consent: The Consent Discussion
  13. Informed Consent: Subjects Who Cannot Read or Write
  14. Informed Consent: Minors and “Mentally Incompetent” Subjects
  15. Informed Consent: Incapacitated Subjects
  16. Informed Consent: 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

  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

4.7
★★★★★★
Average Rating
536 global ratings
★★★★★
87.0%
★★★★★
5.0%
★★★★★
3.0%
★★★★★
3.0%
★★★★★
2.0%
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...

SM

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 designed to arm clinical trial professionals and researchers with crucial knowledge about ethical and scientific standards essential for conducting top-notch clinical trials. This thorough training encompasses 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 dependability of clinical trial data

  • Fostering uniform, superior practices across all facets of clinical research

The Whitehall Training Good Clinical Practice Course thoroughly explores these pivotal areas, offering learners a robust grounding in both the theoretical principles and practical implementation of Good Clinical Practice.

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

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

  • It guarantees adherence to global standards

  • It boosts the credibility and calibre of research

  • It safeguards the rights and well-being of study participants

  • It enhances career opportunities within clinical research

The Whitehall Training GCP course not only provides you with certification but also imparts practical knowledge, enabling you to effectively implement GCP principles in your day-to-day work. This combination of theoretical understanding and hands-on application makes our course particularly valuable for those seeking to excel in clinical research.

GCP certification is crucial for numerous roles within the clinical research field:

  • Lead Researchers and Co-investigators: Those with primary responsibility for overseeing and conducting trials at research facilities.

  • Clinical Study Team Members: This encompasses research assistants, clinical nurses, and other on-site personnel involved in managing the day-to-day aspects of trials.

  • Trial Sponsors and Research Organisations: Individuals responsible for the planning, initiation, and documentation of clinical studies.

  • Regulatory Body Representatives: Officials tasked with assessing and ensuring trial compliance with established standards.

  • Research Ethics Committees: Panellists who review and grant approval for trial protocols.

  • University and Research Centre Staff: Those ensuring that institutional research adheres to international guidelines.

  • Researchers Funded by the National Institute for Health and Care Research (NIHR): All investigators and team members involved in NIHR-supported clinical trials.

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

Additionally, this course proves beneficial for individuals seeking to enhance their research capabilities and streamline their clinical trial operations.

Our Good Clinical Practice (GCP) training programme is a comprehensive guide to the ICH-GCP (E6-R2) international guidelines. It fulfils the training requirements for those wishing to participate in international clinical trials. The course offers a detailed, step-by-step approach to understanding and implementing these crucial guidelines, making it indispensable for anyone involved in clinical trial management.

Developed by an industry veteran with over three decades of experience, including a stint as Research Director at a major pharmaceutical company, this course brings unparalleled expertise to your fingertips. Its global recognition is underscored by its compliance with TransCelerate Biopharma's mutual recognition criteria and accreditation from the Faculty of Pharmaceutical Medicine of the Royal College of Physicians in the UK.

To cater to a diverse audience, we offer the course in multiple languages beyond English, including German, Bulgarian, French, Italian, Japanese, Polish, Portuguese, Russian and Spanish. Furthermore, we've developed region-specific versions tailored to the unique regulatory landscapes of Australia, the UK, the US, France, Germany and Latin America.

The course boasts a user-friendly design with clear, visually engaging content that allows for easy reference to the ICH-GCP E6 document. It goes beyond theory, offering practical insights into GCP application drawn from real-world experience. As an added benefit, participants can earn 6 Continuing Professional Development (CPD) points upon completion, further enhancing their professional credentials.

In essence, this course offers a blend of comprehensive content, practical insights, and global recognition, making it an ideal choice for professionals seeking to excel in clinical trial management.

Indeed. Our GCP courses have received accreditation from The Faculty of Pharmaceutical Medicine of the Royal College of Physicians: Established in 1989, this professional organisation for UK pharmaceutical physicians is renowned for its stringent research standards.

These certifications validate that our courses meet exacting industry and academic criteria, providing you with a qualification that is broadly acknowledged across the sector.

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

  • Official recognition: Has the course been endorsed by credible bodies?

  • International compliance: Does the training meet ICH standards, allowing for participation in global clinical studies?

  • Content quality: 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:

  • Official recognition: Our courses have earned accreditation from the Royal College of Physicians, offering learners 6 official CPD points from the Faculty of Pharmaceutical Medicine.

  • International compliance: Upon completion, researchers are equipped to engage in clinical trials, in line with ICH E6(R2) guidelines.

  • Content quality: The course is crafted by our GCP specialist, Lucy Parker, who brings over ten years of experience managing research across major institutions, including the NHS.

  • Duration of availability: To facilitate ongoing professional development, we provide unlimited access to our course resources.

For group purchases, we offer a 10% discount on orders of 5 licences at checkout. If you're interested in bulk orders, please reach out to our team for additional savings options.