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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. The History of GCP: Part 1
  2. The History of GCP: Part 2
  3. The History of GCP: Part 3
  4. The History of GCP: Part 4
  5. What is GCP?
  6. The Principles of ICaH GCP: Part 1
  7. The Principles of ICH GCP: Part 2
  8. Additional Learning Points
  9. Documentation and Version Control
  10. Quality Assurance (QA)
  11. Key Resources: Part 1
  12. Key Resources: Part 2
  13. Webinar: Introduction to GCP

  1. Introduction: Part 1
  2. Introduction: Part 2
  3. Introduction: Part 3
  4. Introduction: Part 4
  5. Introduction: Part 5
  6. Introduction: Part 6
  7. Introduction: Part 7
  8. Introduction: Part 8
  9. Introduction: Part 9
  10. Responsibilities of the CA
  11. Responsibilities of the IEC
  12. Subject Informed Consent Forms (ICF): Part 1
  13. Subject Informed Consent Forms (ICF): Part 2
  14. Composition, Functions, Operations, Procedures, and Records
  15. IEC Interactions with Sponsors and Investigators

  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
  26. Investigator Responsibilities

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

  1. Introduction
  2. Monitor
  3. The Monitoring Visit: Part 1
  4. The Monitoring Visit: Part 2
  5. Verifying 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. Closing out the Monitoring Visit
  11. The Monitoring Report & Plan
  12. Quality Management - Centralised Monitoring
  13. Fraud and Misconduct: Part 1
  14. Fraud and Misconduct: Part 2

  1. Introduction
  2. AEs, ADRs, & SUSARs
  3. Serious Adverse Events
  4. SUSARs
  5. Adverse Events of Special Interest
  6. Periodic Safety Reports

  1. Introduction
  2. Protocol Structure and Content: Part 1
  3. Protocol Structure and Content: Part 2
  4. Protocol Structure and Content: Part 3

  1. Introduction
  2. Investigator Brochure Structure and Content

  1. Introductions
  2. Archiving
  3. Documents to be Present Pre-Study
  4. Documents to be Present Post-Study

  1. Glossary & Abbreviations
  2. EU Guidance Documents
  3. ICH Guidance Documents
  4. US FDA Guidance Documents
  5. GCP Course Printouts
  6. Global Competent Authorities List

Our GCP certified customers

novartis
NHS
takeda
roche
baxter

Learner Rating & Reviews

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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...

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Frequently Asked Questions

Good Clinical Practice (GCP) training is an essential educational program that equips researchers and clinical trial professionals with the knowledge of ethical and scientific standards crucial for conducting high-quality clinical trials. This comprehensive training covers the internationally recognized guidelines established by the International Council for Harmonisation (ICH).

The primary goals of GCP training are:

  1. Ensuring the protection of human subjects' rights, safety, and well-being
  2. Maintaining the integrity and reliability of clinical trial data
  3. Promoting consistent, high-quality practices across all aspects of clinical research

Our GCP course delves into these critical areas, providing learners with a solid foundation in the principles and practical applications of Good Clinical Practice.

For researchers interested in participating in clinical trials, GCP certification is a necessity.

For those who are simply interested in improving their understanding of the field, GCP certification is highly valuable due to its:

  1. Ensures compliance with international standards
  2. Enhances research credibility and quality
  3. Protects participant rights and safety
  4. Improves career prospects in clinical research

Our course not only provides certification but also equips you with practical skills to apply GCP principles effectively in your work.

GCP certification is essential for a wide range of professionals in clinical research:

  1. Clinical Trial Investigators: Principal investigators and sub-investigators responsible for trial conduct at research sites.
  2. Clinical Trial Staff: Including research coordinators, study nurses, and other site personnel involved in trial management.
  3. Sponsors and Contract Research Organizations (CROs): Those overseeing trial planning, initiation, and reporting.
  4. Regulatory Authorities: Officials who monitor and evaluate trial compliance.
  5. Institutional Review Boards (IRBs) and Ethics Committees: Members reviewing and approving trial protocols.
  6. Academic and Research Institution Staff: Ensuring adherence to international standards in institutional research.
  7. NIH-Funded Researchers: All investigators and staff involved in NIH-funded clinical trials.

Our course caters to this diverse audience, providing role-specific insights alongside core GCP principles. The course is also valuable for anyone looking to upskill their research abilities and improve their clinical trials operations.

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. Multiple language versions are available. This GCP training course is a step-by-step and up-to-date guide to the international ICH-GCP (E6-R2) guidelines. It is essential for anyone taking part in the running of a clinical trial.

The course was written by an expert with over 30 years of experience up to the Research Director level in a major pharma group. Our ICH GCP training is accepted worldwide as it meets the TransCelerate Biopharma mutual recognition criteria. Also, it is accredited by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. Apart from English, the course is available in German, Bulgarian, French, Italian, Japanese, Polish, Portuguese, Russian and Spanish. We also produce regional versions of this course tailored to the specific regulatory frameworks in Australia, the UK, the US, France, Germany and Latin America.

This course features a clear and visually appealing format, allowing for easy cross-referencing to the ICH-GCP E6 document. It offers valuable insights into the practical application of Good Clinical Practice (GCP) based on the author's extensive experience. Furthermore, it is accredited by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom and provides participants with the opportunity to earn 6 CPD points.

Yes, our GCP course is accredited by two industry-leading organisations:

  1. TransCelerate Biopharma Inc.: A nonprofit organisation collaborating with 20 major pharmaceutical companies. Their mutual recognition program is considered the gold standard in the field of clinical practice.
  2. The Faculty of Pharmaceutical Medicine at the Royal College of Physicians: The professional membership body for pharmaceutical physicians in the UK, known for setting rigorous standards for research since 1989.

These accreditations ensure our course meets the highest industry and academic standards, offering you a widely recognized certification.

Costs vary depending on the following factors:

  • Accreditation: Is the course approved by official organisations, like TransCelerate?)
  • Certification: Does the course meet the ICH requirements that allows researchers to participate in international clinical trials?
  • Quality of content: Is the course up-to-date, and written by an expert?
  • Access: How long are learners able to access the course?

Whitehall Training’s GCP course is £79 due to its:

  • Accreditation: It is TransCelerate approved, and accredited by the Royal College of Physicians with 6 CPD points.
  • Certification: The course enables users to participate in clinical trials, following the ICH E6(R2) guidelines.
  • Quality of content: Our course is written by our Good Clinical Practice expert, Lucy Parker, who has over a decade of experience directing research across large research institutes such as the NHS.
  • Access: To support the lifelong learning of our researchers, we provide lifetime access to our course resources.

Buying for a team? We offer 10% off orders of 5 licences at checkout. For discounts on larger orders, please get in touch with our team.