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Clinical Practice
Pharmacovigilance
Manufacturing
Laboratory Practice
Distribution
MDR

About

This course offers an interactive and visually appealing learning experience. It reinforces your knowledge through problem-solving, allows easy cross-referencing with the ICH-GCP E6 document, includes multiple-choice questions for exam preparation, and provides insights from the author's extensive experience. It is accredited with 8 CPD points by 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. 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

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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...