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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
  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 - 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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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 a vital educational programme designed for professionals involved in clinical research. It provides comprehensive instruction on the ethical and scientific standards that are fundamental to conducting high-quality clinical trials. This training is based on the globally acknowledged guidelines set forth by the International Council for Harmonisation (ICH).

The key objectives of GCP training include:

  • Safeguarding the rights, safety, and wellbeing of human participants
  • Upholding the accuracy and reliability of data collected during clinical trials
  • Fostering uniform, top-tier practices across all facets of clinical research

Whitehall Training's Good Clinical Practice Course thoroughly explores these crucial areas, offering participants a robust understanding of both the theoretical principles and practical applications of Good Clinical Practice. Our course ensures that learners are well-equipped to navigate the complexities of clinical research while adhering to the highest standards of ethical and scientific conduct.

For those involved in clinical trials research, GCP certification is essential.

If you're keen to broaden your knowledge of the field, obtaining GCP certification is tremendously advantageous because it:

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

The Whitehall Training GCP course not only offers certification but also imparts practical know-how for effectively implementing GCP principles in your professional endeavours.

GCP certification is crucial for numerous professionals involved in clinical research:

  • Trial Investigators: This includes both lead investigators and co-investigators who are accountable for the execution of trials at research locations.
  • Clinical Research Team Members: Encompassing research coordinators, trial nurses, and other on-site personnel who play a role in managing the study.
  • Sponsors and CROs: Individuals responsible for overseeing the planning, commencement, and documentation of trials.
  • Regulatory Bodies: Officials tasked with supervising and assessing trial compliance.
  • Ethics Committees and IRBs: Those who review and grant approval for trial protocols.
  • Staff at Research Institutions and Universities: Ensuring that institutional research adheres to global standards.
  • Researchers Funded by the NIH: All staff and investigators participating in clinical trials supported by NIH funding.

Whitehall Training's Good Clinical Practice Course is designed to accommodate this broad spectrum of professionals, offering both role-specific knowledge and fundamental GCP principles. The course is also beneficial for individuals seeking to enhance their research capabilities and refine their clinical trial operations.

Our Good Clinical Practice (GCP) course provides comprehensive coverage of the ICH-GCP (E6-R2) international guidelines, fulfilling the training requirements for participation in global clinical trials. We offer this course in multiple languages to cater to a diverse audience.

This in-depth training 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.

The course content has been developed by an industry veteran with over three decades of experience, including a stint as Research Director at a prominent pharmaceutical company. Our training has received accreditation from the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom, underscoring its quality and relevance.

To accommodate our international learners, we've made the course available in ten languages: English, German, Bulgarian, French, Italian, Japanese, Polish, Portuguese, Russian, and Spanish. Additionally, we've crafted regional variants of the course to align with the specific regulatory landscapes in Australia, the UK, the US, France, Germany, and Latin America.

Our GCP course boasts a user-friendly design with clear, visually engaging content, facilitating easy cross-referencing with the ICH-GCP E6 document. Drawing from the author's extensive industry experience, the course offers practical insights into the real-world application of Good Clinical Practice principles. Upon completion, participants can earn 6 Continuing Professional Development (CPD) points, further enhancing their professional credentials.

Indeed, our GCP course has received accreditation from a prestigious body in the UK. The Faculty of Pharmaceutical Medicine at the Royal College of Physicians has given its stamp of approval to our programme. This organisation is well-known in the pharmaceutical industry, having established itself as a leader in setting comprehensive research standards since its inception in 1989.

The Faculty's accreditation of our course serves as a testament to its quality and relevance. It signifies that the content and delivery of our GCP training meet the exacting standards set by this professional body for pharmaceutical physicians in the United Kingdom.

By completing our accredited course, you'll gain a qualification that is widely respected within the industry. This recognition can be particularly valuable for professionals seeking to demonstrate their commitment to maintaining high standards in clinical research practices.

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

  • Endorsement: Has the course received approval from recognised bodies?
  • Qualification: Does the training fulfil ICH standards, allowing participants to engage in global clinical studies?
  • Content standard: Is the material current and authored by a subject matter expert?
  • Duration of availability: For how long can students access the course materials?

Our Whitehall Training GCP course is priced at £79, reflecting its high-quality attributes:

  • Endorsement: The Royal College of Physicians has accredited the course, awarding 6 CPD points.
  • Qualification: Upon completion, learners are equipped to take part in clinical trials, in line with ICH E6(R2) guidelines.
  • Content standard: The course material 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: We support ongoing professional development by offering 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 bookings, please contact our team to discuss bespoke pricing options.