Good Clinical Practice for Clinical Research Professionals

🎓 Complete, Certified ICH GCP E6 (R2+R3) Course for Investigators, Study Coordinators, Sponsors, Monitors and Study Staff 🌟

Course Updates:

• June 2024: Added ICH-GCP (R3) Annex 2 concept paper to the resources.
• January 2024: Updated the Bonus section; added feedback on Step 2 of the ICH E6 (R3) process to the comments sent to the ICH E6 (R3) Expert Working Group.
• September 2023: Updated with new sections on ICH GCP R3 Draft Principles and added resource documentation.
• August 2023: List of Acronyms and Abbreviations used in the course (section 1) added for your convenience.
• June 2023: Added a detailed summary of ICH GCP E6 (R2) and a comparison with ICH GCP E6 (R3).
• April 2023: Included new case studies to illustrate the application of ICH GCP principles in practice.

About the Course:

🚀 Course Overview: This comprehensive course, led by Dr. Vincent, is designed to equip you with a thorough understanding of the International Council for Harmonisation's Good Clinical Practice (ICH GCP) E6 guidelines. With a focus on both Revisions 2 and 3, this course is perfect for anyone involved in clinical research, from beginners to those looking to deepen their knowledge.

What You Will Learn:

• The Fundamentals of GCP: Understand the importance and history behind GCP and its role in ensuring the rights, safety, and well-being of participants in clinical trials.
• Link with Declaration of Helsinki: Explore the relationship between GCP and ethical research standards as outlined in the Declaration of Helsinki.
• Key Definitions & Concepts: Master the language of clinical research, including stakeholders and essential documents.
• ICH GCP Principles (R2 & R3): Learn the principles of both revisions with practical advice on their application.
• Ethics Committees: Understand the composition, function, and obligations of Ethics Committees in clinical trials.
• Investigator Responsibilities: Gain insights into the qualifications, compliance responsibilities, and effective communication required from an Investigator.
• Writing Protocols & Investigator's Brochure: Learn how to draft a protocol and investigator's brochure that are clear, compliant, and compliant with regulatory requirements.
• Essential Documents & TMF: Get to grips with the purpose of essential documents and where to file them within the Trial Master File (TMF).
• Common Audit/Inspection Findings: Study practical exercises on common findings from FDA and MHRA inspections.

Course Features:

• 🎥 Interactive Lectures: Each concept is broken down into smaller, manageable lectures to facilitate learning for all levels of students.
• ⏫ Adjustable Speed: For advanced students, the option to speed up playback is available to learn at their own pace.
• 📚 Inclusive Content: Complete with a glossary of terms and comprehensive explanations.
• 🧠 Quizzes & Final Exam: To test your knowledge throughout and after the course.
• ☎️ Personal Q&A Session: Spend an hour with Dr. Vincent post-course to address all your questions!
• 📅 Live Q&A: Dr. Vincent is available personally during the course for any questions or comments.

Course Benefits:

• Regulatory Inspection Readiness: Prepare for successful regulatory ICH GCP inspections and audits with confidence.
• Real-World Application: Receive practical tips & tricks to apply ICH GCP in your daily practice immediately.
• Expert Guidance: Learn from Dr. Vincent, an expert with hands-on experience in the field.

Enrollment Includes:

• Access to all lectures and course materials.
• Interactive quizzes and a comprehensive final exam.
• The opportunity to discuss your questions with an ICH GCP expert for one hour after course completion.
• Ongoing support from Dr. Vincent throughout the course.

Ready to Get Started?

📫 After completing the course, don't forget to schedule a 1-hour session with Dr. Vincent by sending an email with your questions and contact details. He's eager to assist you in any way he can!

Join us today and take the first step towards becoming an ICH GCP expert! 🎓

Note: This course is intended for individuals who are involved or will be involved in clinical research, including Investigators, Study Coordinators, Sponsors, Monitors, and other study staff. If you have any questions about the content or structure of the course, please don't hesitate to reach out!