Good Clinical Practice (GCP)
12 Hours / 3 Days - From 5:00 PM Till 9:00 PM (GMT+3)
This course is designed for healthcare professionals, who have limited experience and no formal training in Good Clinical Practices (GCP). It offers a comprehensive yet concentrated overview of the principles of GCP, FDA and Global Regulations, and the roles and responsibilities of the clinical investigator/site, IRB, sponsor, and study monitor.
- Understand the basics of GCP and the current legal regulations and guidelines
- Have the confidence to identify and describe the main responsibilities of the IRB, the investigator, the sponsor and the monitor
- Be familiar with the essential documents related to GCP and understand the essence and purpose of important trial-related files, such as the informed consent forms, the investigator’s brochure, and the clinical trial protocol
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