ECSafetyReporting object

Reportable AEs

SAE (Serious Adverse Event)
SADE (Serious Adverse Device Effect)

Responsible for AE reporting to relevant EC(s)

Manufacturer acting as sponsor

SAE/SADE must be reported

Immediately (without delay)

Guidance on AE reporting procedure

Related information can be found on the CCMO website in section: Home>Investigators>Types of research>Research with a medical device.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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