Good Clinical Practice for Investigators and Site Personnel
ICH-GCP E6 (R2) training for clinical investigators & site staff. Get certified in Good Clinical Practice. Essential for clinical research.
Course Content
Good Clinical Practice for Investigators and Site Personnel is an all-levels Udemy course taught by Dr. Vincent Baeyens. It runs 1h 34m, is taught in English, and includes a certificate of completion. Learners rate it 4.3 out of 5 from 33 reviews, with 61 students enrolled. It is a paid course, last updated February 2023.
Welcome to the comprehensive ICH-GCP (R2) course designed for Clinical Investigators and Site Personnel! This training meets the minimum criteria for ICH E6 (R2) GCP Investigator and Site Personnel Training, facilitating GCP training recognition.
This course is essential for Investigators, Co-investigators, Study Coordinators, and all Clinical Study staff involved in executing clinical trials at Clinical Sites. Gain full lifetime access to GCP Revision 2 and all future updates from the ICH.
Led by Dr. Vincent Baeyens PhD, with over 20 years of experience in Clinical Trial Management within global Pharma and Biotech, this course is built on practical, real-world ICH-GCP requirements. We'll delve into the critical roles and responsibilities of Clinical Investigators and Site Personnel.
What you will learn:
- Understanding GCP: Learn what is GCP and its crucial importance in clinical research.
- GCP & Declaration of Helsinki: Explore the connection between the Declaration of Helsinki and current GCP guidelines.
- Key Terminology: Define essential terms and concepts used in clinical research, including stakeholders and key processes.
- Applying ICH-GCP Principles: Understand the ICH-GCP principles and practical advice for implementation in your clinical trials.
- Investigator Responsibilities: A detailed review of Investigator responsibilities throughout the trial lifecycle, including qualifications, protocol compliance, Ethics Committee communication, safety reporting, and final reporting.
- Avoiding Audit Findings: Learn about common ICH-GCP audit and inspection findings and strategies to avoid GCP violations.
- GCP Inspections & Audits: Prepare for successful site regulatory inspections and audits.
The course includes quizzes to reinforce your learning. Explore the course content and don't hesitate to contact me with any questions!
Sincerely,
Vincent
Recent Updates:
- February 2023: Added awareness of the most common GCP findings (Lecture 4).
- January 2023: Edited English subtitles and added French subtitles.
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