| 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
Description
Welcome !This course is a refresher ICH GCP course for Investigators and staff personnel requiring to maintain up-to-date their knowledge in GCP.This course meets the Minimum Criteria for ICH E6 GCP Investigator and Site Personnel Training that TransCelerate has identified as necessary to enable mutual recognition of GCP training.My name is Dr. Vincent Baeyens PhD, I have more than 20 years of experience in running Clinical Trials in Global and mid-size Pharma, and Biotech settings. I have worked with most of the Global as well as several niche CROs and I am also an expert in CRO Management and Oversight, budgeting and Risk Management. I will lead you step-by-step through the ICH GCP E6, and you will learn & understand:What is GCP and why GCP is important in clinical researchThe definition of the key definitions of terms and concepts used in clinical research, including stakeholders involved and essential documentsThe ICH GCP Principles and practical advices to apply them in your clinical trialsThe detailed responsibilities of the Investigator throughout the trial, including his/her qualifications, compliance to protocol, communication with Ethics Committees, safety reporting, and final reportingFeel free to look at the content of the course to know more and contact me any time if you have any questions,I am looking forward to seeing you inside the course!Sincerely,Vincent---
This course is intended to all professionals involved in clinical research, such as clinical project manager, investigator, study nurse, study coordinator willing to comply with ICH-GCP