ECSafetyReporting object
Adverse Events (AE) - Definitions (pursuant to national law)
Definitions:
• SAE: According to the EU Commission guidelines
• SAE- Near incidents: include situations in which SAEs could have occurred if suitable action had not been taken or if circumstances had been less fortunate.
• SAE- Malpractice: SAEs caused by imprecise or incomplete results from diagnostic equipment leading to incorrect diagnosis, delayed diagnosis or delayed or incorrect treatment
