The reporting of adverse event data to regulatory agencies is undergoing a transition from paper-based reporting like the FDA's MedWatch forms (or CIOMS* forms in many other countries) to electronic reporting. This reporting method uses a standardized format that specifies the structure of the data elements and technical aspects of the data transmission and enables near-simultaneous transmission to multiple agencies.
[ Ссылка ]
Adverse Event Reporting
![](https://i.ytimg.com/vi/z8Or5aeIUJQ/mqdefault.jpg)