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. The History of GCP
  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: Part 1
  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
  7. 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: Part 1
  10. Investigational Medicinal Products: Part 2
  11. Randomisation Procedures and Un-blinding
  12. Informed Consent of Trial Participants
  13. Data Collections and Expression of Results
  14. The Consent Discussion
  15. Obtaining Consent: Subjects Who Cannot Read or Write
  16. Obtaining Consent: Minors and “Mentally Incompetent” Subjects
  17. Obtaining Consent: Incapacitated Subjects
  18. Obtaining Consent: Updating Consent
  19. Records and Reports: Introduction
  20. Records and Reports: Study Site Files
  21. Records and Reports: Updates & Amendments
  22. Records and Reports: Source Documents
  23. Records and Reports: Financial Information
  24. Records and Reports: The Case Record Form
  25. Records and Reports: Recording Subject Data
  26. Premature Termination or Suspension of a Trial
  27. Progress Reports and Final Reports by Investigator
  28. Archiving

  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 Expertise
  9. Trial Design
  10. Trial Management: Part 1
  11. Trial Management: Part 2
  12. Data Processing: Part 1
  13. Data Processing: Part 2
  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 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: Part 1
  3. Monitoring: Part 2 – Monitor Responsibilities
  4. Monitoring: Part 3 - The Follow-up Visit
  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
  10. Closing out the Monitoring Visit
  11. The Monitoring Report & Plan
  12. Quality Management - Centralised Monitoring
  13. 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 – EIGI
  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

  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

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 equip clinical research professionals with the essential knowledge and skills needed to conduct high-quality clinical trials. This comprehensive course focuses on the ethical and scientific standards 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 data
  • Fostering uniform, top-tier practices across all clinical research activities

Whitehall Training's Good Clinical Practice Course thoroughly explores these crucial aspects, offering learners a robust understanding of GCP principles and their practical implementation in clinical research settings.

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

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

  • It aligns your practice with global standards
  • It bolsters the reliability and calibre of your research
  • It safeguards the rights and well-being of study participants
  • It opens up more career opportunities within clinical research

The Whitehall Training Good Clinical Practice Course not only grants you certification but also imparts practical know-how for effectively implementing GCP principles in your day-to-day work.

GCP certification is crucial for a diverse array of roles within clinical research:

  • Lead and Assistant Investigators: Those who oversee and conduct trials at research facilities.
  • On-site Trial Team: This includes study coordinators, research nurses, and other personnel involved in the day-to-day management of trials.
  • Trial Organisers and Outsourced Research Firms: Individuals responsible for the planning, commencement, and documentation of trials.
  • Regulatory Bodies: Officials tasked with ensuring trials adhere to established guidelines.
  • Ethical Review Committees: Groups that assess and approve trial protocols.
  • University and Research Centre Personnel: Staff ensuring institutional research meets international benchmarks.
  • Government-Funded Research Teams: All staff participating in publicly funded clinical studies.

Whitehall Training's Good Clinical Practice Course is tailored to meet the needs of this wide-ranging audience, offering both role-specific knowledge and fundamental GCP concepts.

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 provide comprehensive coverage of the ICH-GCP (E6-R2) international guidelines. It fulfils the training requirements for those wishing to participate in international clinical trials. We've structured the course as a detailed, current guide to these crucial guidelines, making it an indispensable resource for anyone involved in clinical trial operations.

The course content has been crafted by a seasoned professional boasting over three decades of experience, including a tenure as Research Director at a prominent pharmaceutical company. This wealth of experience ensures that the material is both practical and relevant.

We're proud to offer this course in multiple languages, including English, German, Bulgarian, French, Italian, Japanese, Polish, Portuguese, Russian and Spanish. Additionally, we've developed regional variants tailored to the specific regulatory frameworks in Australia, the UK, the US, France, Germany and Latin America.

One of the key strengths of our GCP course is its user-friendly format. The clear, visually engaging presentation allows for effortless cross-referencing with the ICH-GCP E6 document. Moreover, the course provides valuable practical insights into the application of GCP principles, drawn from the extensive experience of its author.

We're delighted that our course has received accreditation from the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. This accreditation underscores the quality and relevance of our training material. Upon completion, participants can earn 6 Continuing Professional Development (CPD) points, further enhancing the value of this learning experience.

Indeed, our GCP course has received accreditation from a highly respected body in the field. The Faculty of Pharmaceutical Medicine at the Royal College of Physicians has given its seal of approval to our programme. This organisation is renowned as the professional membership body for pharmaceutical physicians in the United Kingdom and has been establishing stringent research standards since 1989.

The accreditation from such a prestigious institution serves as a testament to the quality of our course. It demonstrates that our programme meets exacting industry and academic benchmarks, providing you with a qualification that is widely acknowledged in the field.

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

  • Endorsement: Has the course received approval from recognised bodies?
  • Qualification: Does the training fulfil ICH criteria, allowing researchers to engage in global clinical studies?
  • Content standard: Is the material current and authored by a subject matter expert?
  • Availability: What is the duration of learner access to the course materials?

At Whitehall Training, our GCP course is priced at £79, reflecting its:

  • Endorsement: The course holds accreditation from the Royal College of Physicians, offering 6 CPD points.
  • Qualification: Upon completion, participants are equipped to take part in clinical trials, in line with ICH E6(R2) guidelines.
  • Content standard: Our GCP specialist, Lucy Parker, who boasts over ten years of experience managing research across major institutions like the NHS, has crafted the course content.
  • Availability: To facilitate ongoing professional development, we grant unlimited access to our course resources.

Are you purchasing for a group? A 10% discount is automatically applied at checkout for orders of 5 licences. For larger group purchases, please reach out to our team to discuss bespoke pricing options.