Good Clinical Practice (GCP)

Good Clinical Practice (GCP) is organized by Osten Healthcare and will be held from Jun 13 - 15, 2022. This course has been approved for a maximum of 12 Contact Hours.

Course Description:
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.

Course Learning Objectives:
• 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