Good Clinical Practice for Investigators and Site Personnel
Why take this course?
🎓 [ICH-GCP E6 (R2) Comprehensive Training for Clinical Investigators & Site Personnel]
Welcome to the Definitive Guide in Good Clinical Practice (GCP)! This is your gateway to mastering ICH-GCP (R2) as outlined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Our course is meticulously designed to meet the Minimum Criteria for ICH E6 (R2) GCP Investigator and Site Personnel Training, as recommended by TransCelerate.
What's in Store for You?
- Lifetime Access: Dive into a comprehensive understanding of GCP Revision 2 and all subsequent revisions by the ICH.
- Expert Insights: Led by Dr. Vincent Baeyens, PhD, with over 20 years of experience in global clinical trial management, this course is a distillation of best practices.
- Essential Knowledge: Whether you are an Investigator, Co-investigator, Study Coordinator, or any other staff involved in clinical study execution, this course equips you with the essential GCP knowledge.
- Regulatory Mastery: Prepare for successful site regulatory inspections and audits with a strong foundation in ICH-GCP compliance.
Course Highlights:
- Foundation of GCP: Understand the importance of GCP within clinical research and its alignment with the Declaration of Helsinki.
- Key Definitions & Stakeholders: Grasp the core definitions and concepts, including stakeholder roles and processes in clinical research.
- ICH-GCP Principles: Learn practical advice on applying these principles in your clinical trials.
- Investigator Responsibilities: Explore comprehensive guidelines on the qualifications, responsibilities, and compliance expectations of an Investigator.
- Common Issues & Solutions: Identify common audit and inspection findings and learn how to avoid them.
- Interactive Learning: Engage with quizzes that help solidify your understanding of GCP.
Course Structure:
- Introduction to GCP: What is GCP and why it's critical for ethical clinical research?
- ICH-GCP Framework: A detailed look at the ICH-GCP principles and their practical application.
- Investigator's Role: Understanding your responsibilities, from protocol compliance to safety reporting and final reporting.
- Regulatory Inspections: Preparing for and navigating GCP inspections and audits.
- Avoiding Common Pitfalls: Learning from the most common findings in GCP audits and how to prevent these issues.
- Interactive Quizzes: Reinforce your learning and assess your knowledge throughout the course.
Why Choose This Course?
- Expert Leadership: Gain insights from someone with decades of practical experience in clinical trial management.
- Comprehensive Content: From basic principles to advanced responsibilities, this course covers it all.
- Flexible Learning: Access the material whenever and wherever you need, with full lifetime access.
- Community Support: Join a community of clinical trial professionals and engage in discussions and knowledge sharing.
Ready to embark on your journey to GCP mastery? 🚀 Contact me for any questions, or dive right in to explore the course content further. I'm here to guide you through every step of this critical learning path.
Best regards, Dr. Vincent Baeyens PhD 📚👩⚕️🔬
Loading charts...