ECSafetyReporting object
Adverse Events (AE) - Definitions (pursuant to national law)
The definitions for AD, SAE, SADE are provided in Art 2 Circular 7/2004/
Royal Decree 1090/2015
Reportable AEs
SUSAR (Suspected Unexpected Serious Adverse Reaction) in combination studies only
SADE (Serious Adverse Device Effect)
Investigator shall report SAE to
Sponsor
Reporting timeline
Immediately (without delay)
Responsible for AE reporting to relevant EC(s)
Sponsor
SAE/SADE must be reported
Within a max of 7 d upon first knowledge (+8d for additional information) for events being life-threatening or leading to death
Within a max of 15d upon first knowledge
National Standard Reporting form available
Not specified
Provision of Annual safety report mandatory
Yes
Additional Information
For Combination studies (MD+MP) when the AE is associated to the MP, only SUSARs (Suspected Unexpected Adverse Reaction) are reported (in compliance with the reporting timelines).
