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
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. What is GCP?
  2. Why is ICH GCP important?
  3. The Principles of ICH GCP
  4. Additional Learning Points
  5. Documentation and Version Control
  6. Quality Assurance (QA)
  7. 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: 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. 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 (CROs)
  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 – Systems Electronic Data
  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 – The Monitor’s Responsibilities
  4. Monitoring: Part 3 – The Monitoring Visit
  5. Monitoring: Part 4 - Verifying IMP
  6. Monitoring: Part 5 - Complying with the Protocol, Amendments, SOP and Guidance
  7. Monitoring: Part 6 - Verifying Informed Consent
  8. Monitoring: Part 7 - The Case Record Form (CRF) and Source Documents
  9. Monitoring: Part 8 - Verifying Subject Data
  10. Monitoring: Part 10
  11. The Monitoring Report & Plan
  12. Quality Management - Centralised Monitoring
  13. Fraud and Misconduct

  1. Introduction
  2. Adverse Events: Part 1
  3. Adverse Events: Part 2
  4. Adverse Events: Part 3
  5. Adverse Events: Part 4
  6. Adverse Events: Part 5
  7. Adverse Events: 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

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 crucial educational programme designed to equip clinical trial professionals and researchers with essential knowledge of ethical and scientific standards. This comprehensive course focuses on the guidelines set forth by the International Council for Harmonisation (ICH), which are globally recognised in the field of clinical research.

The core objectives of GCP training include:

  • Safeguarding the rights, safety, and well-being of human participants
  • Upholding the reliability and integrity of clinical trial data
  • Fostering consistent, high-quality practices throughout all stages of clinical research

Whitehall Training's Good Clinical Practice Course thoroughly covers these vital areas, offering participants a robust understanding of both the theoretical principles and practical applications of GCP. Our course ensures that learners gain the necessary skills to conduct clinical trials in accordance with international standards, promoting excellence in research practices.

For individuals seeking involvement in clinical trials research, obtaining GCP certification is essential.

Those looking to broaden their knowledge of the clinical research landscape will find GCP certification particularly beneficial for several reasons:

  • It guarantees adherence to globally recognised standards
  • It bolsters the reliability and calibre of research conducted
  • It safeguards the rights and well-being of study participants
  • It opens up new career opportunities within clinical research

The Whitehall Training Good Clinical Practice Course not only provides the necessary certification but also imparts practical knowledge for effectively implementing GCP principles in your professional role.

Good Clinical Practice (GCP) certification is a crucial requirement for numerous professionals involved in clinical research. The following roles typically necessitate GCP training:

  • Lead and Assistant Investigators: Those who oversee and conduct trials at research facilities.
  • On-site Clinical Trial Team: This includes research assistants, clinical nurses, and other personnel involved in managing the day-to-day aspects of trials.
  • Trial Sponsors and Research Organisations: Individuals responsible for the planning, commencement, and documentation of trials.
  • Regulatory Body Representatives: Officials tasked with ensuring trials adhere to established protocols and regulations.
  • Ethics Committees and Review Boards: Members who assess and approve trial methodologies.
  • Staff at Research Institutions and Universities: Those ensuring institutional research meets international benchmarks.
  • Researchers Funded by National Health Bodies: All staff and investigators working on clinical trials supported by national health organisations.

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

Additionally, the course proves beneficial for individuals aiming to enhance their research competencies and streamline their clinical trial processes.

Our Good Clinical Practice (GCP) training programme 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 course in multiple languages to cater to a diverse audience.

This in-depth course serves as a contemporary, step-by-step guide to the ICH-GCP (E6-R2) guidelines, making it an indispensable resource for all individuals involved in clinical trial management and execution.

Developed by an industry veteran with over three decades of experience, including a tenure as Research Director at a leading pharmaceutical company, our course carries the prestigious accreditation from the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom.

To accommodate our international learners, we've made the course available in a variety of languages beyond English, including German, Bulgarian, French, Italian, Japanese, Polish, Portuguese, Russian and Spanish. Additionally, we've crafted specialised regional versions of the course, tailored to align with the specific regulatory frameworks in Australia, the UK, the US, France, Germany and Latin America.

Our course boasts a user-friendly, visually engaging format that facilitates easy cross-referencing with the ICH-GCP E6 document. Drawing from the author's extensive practical experience, it offers valuable insights into the real-world application of Good Clinical Practice principles. As an added benefit, participants can earn 6 CPD points upon successful completion of this accredited programme.

Indeed, our GCP course has received certification from a prestigious body. The Faculty of Pharmaceutical Medicine at the Royal College of Physicians has given its stamp of approval to our training programme. This organisation is well-known in the UK as the professional membership body for pharmaceutical physicians and has been establishing stringent research standards since 1989.

The certification we've received is a testament to the quality of our course. It demonstrates that our training meets the exacting standards set by both the industry and academic institutions. As a result, when you complete our GCP course, you'll earn a qualification that is widely acknowledged and respected in the field.

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

  • Endorsement: Has the course received approval from recognised bodies in the field?
  • International recognition: Does the training meet ICH standards, allowing participants to engage in global clinical studies?
  • Content excellence: Is the material current and authored by industry professionals?
  • Duration of availability: For how long can students access the course materials?

At Whitehall Training, we offer our comprehensive GCP course for £79. This competitive price point reflects:

  • Our endorsement by the Royal College of Physicians, which awards 6 CPD points upon completion.
  • Full compliance with ICH E6(R2) guidelines, enabling graduates to participate in international clinical trials.
  • Expert-crafted content by Lucy Parker, our GCP specialist with over 10 years of experience leading research initiatives in major institutions like the NHS.
  • Unlimited access to course resources, supporting ongoing professional development for researchers.

For those purchasing multiple licences, we provide a 10% discount on orders of 5 or more at checkout. If you're interested in bulk pricing for larger teams, please contact our sales department for a tailored quote.