Develop a better understanding of the overall drug development process and how each study fits into the “big picture” of the development life cycle. This eLearning course puts into practice the ICH E8 guidance document General Considerations for Clinical Trials.
Implement a Quality Management System (QMS) and prevent findings related to patient safety, data quality and regulatory compliance. This eLearning course will teach you risk management strategies to avoid inaccurate trial data, regulatory non-compliance and more.
Learn how to set up and manage electronic clinical research documents in compliance with U.S. and EU regulations, and current trends from both the site and sponsor perspectives. This eLearning course examines the challenges of working with electronic documents and how to overcome them.