Good Clinical Practice Refresher For Investigators https://WebToolTip.com MP4 | Video: h264, 1920x1080 | Audio: AAC, 44.1 KHz
Language: English | Size: 1003.59 MB | Duration: 1h 34m
Complete, Certified ICH GCP E6 (R3) Course for Investigators and Site Personnel
What you'll learn
Identify and understand the ICH-GCP requirements throughout the conduct of clinical trials
Learn the core principles of ICH-GCP R3 and how to implement them in practice
Define the roles and responsibilities of each involved key stakeholder: Ethics Committees, Sponsors and Investigators
Understand the purpose of the essential documents and the best practice for filing in the TMF
Understand the essential requirements and contents of the Investigator's Brochure and the Protocol
Practice on real cases: Identify common ICH-GCP inspection findings (FDA warning letters) and how to avoid them
Practice on real cases: Conduct a gap analysis in your organization based on a real MHRA inspection report
Requirements
No prior working experience or knowledge in clinical research is required to attend this course
This course is dedicated to beginners as wells as to more advanced professionals willing to refresh their knowledge