1222 Courses

This course explains the regulatory requirements for the reporting of adverse events and suspected adverse reactions in clinical trials. It describes how investigators should report to sponsors, and how sponsors should report to regulatory authorities and other stakeholders in the safety of investigational products. It explains how events are characterized as serious or non-serious, expected or unexpected, and it distinguishes the requirements for each category. It describes controlled vocabularies used for coding of events in reports.

Immerse yourself in the science and art of attention to power up your knowledge, make shifts towards increased mindfulness, mental resilience, improved focus and sense of wellbeing.