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Clinical Practice
Pharmacovigilance
Manufacturing
Laboratory Practice
Distribution
MDR

About

This course offers an engaging and visually appealing learning experience. It includes problem-solving exercises to enhance your understanding as you progress. The content facilitates easy cross-referencing with the ICH-GCP E6 document and incorporates multiple choice questions for exam preparation. You'll also benefit from the author's extensive experience, gaining valuable insights into GCP application. Successful completion of the course rewards you with 8 CPD points and accreditation from The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom.

Course Syllabus

  1. The History of GCP: Part 1
  2. The History of GCP: Part 2
  3. What is GCP?
  4. Introduction to GCP (Mini-Exam)
  5. How was GCP Introduced to the UK
  6. The Principles of ICH GCP
  7. Additional Learning Points
  8. Documentation and Version Control
  9. Quality Assurance (QA)
  10. MHRA GCP Inspections
  11. Key Resources
  12. Introduction to GCP (Webinar)

  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
  6. Communication with IRB/IEC
  7. Compliance with the Protocol
  8. Investigational Medicinal Products (IMPs)
  9. Randomisation Procedures and Un-blinding
  10. Informed Consent of Trial Participants
  11. Informed Consent of Trial Participants: The Consent Discussion
  12. Informed Consent of Trial Participants: Obtaining Consent Subjects Who Cannot Read or Write
  13. Informed Consent of Trial Participants: Obtaining Consent of Minors and “Mentally Incompetent” Subjects
  14. Informed Consent of Trial Participants: Obtaining Consent and Incapacitated Subjects
  15. Informed Consent of Trial Participants: Updating Consent
  16. Records and Reports: Introduction
  17. Records and Reports: Study Site Files
  18. Records and Reports: Updates & Amendments
  19. Records and Reports: Source Documents
  20. Records and Reports: Financial Information
  21. Records and Reports: The Case Record Form (CRF)
  22. Records and Reports: Recording Subject Data
  23. Premature Termination or Suspension of a Trial
  24. Progress Reports and Final Reports by Investigator
  25. 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. Trial Design
  9. Trial Management: Part 1
  10. Trial Management: Part 2 – Data Management
  11. Trial Management: Part 3 – Electronic Data Systems
  12. Trial Management: Part 4 – Record Keeping
  13. Investigator Selection: Introduction
  14. Investigator Selection: Permissions
  15. Investigator Selection: Responsibilities
  16. Investigator Selection: Compensation
  17. Financing
  18. Notification/ Submission to Regulatory Authorities
  19. Gaining CA Approval in the EU
  20. Confirmation of Review by IRB/IEC
  21. Manufacturing, Packaging, Labelling, and Coding Investigational Products: Part 1
  22. Manufacturing, Packaging, Labelling, and Coding Investigational Products: Part 2
  23. Supplying and Handling Investigational Products
  24. Audit and Inspection
  25. Noncompliance
  26. Premature Termination or Suspension of a Trial
  27. Clinical Trial/Study Reports
  28. 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 in CRFs
  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
  3. Adverse Drug Reaction Reports: Part 2 – Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)
  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: Part 1
  3. Protocol Structure and Content: Part 2 – Selection and Withdrawal of Subjects
  4. Treatment of Subjects

  1. Introduction
  2. Table of Contents of Investigator's Brochure (Example)

  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

Our GCP certified customers

novartis
NHS
takeda
roche
baxter

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