Good Clinical Practices (GCP) for Clinical Trials with Investigational Drugs
8 Contact Hours - 2 Days
Overview This training is designed for healthcare professionals, who have limited experience with 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.
Objectives
Objectives
At the end of the training, participants will:
- 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