CASafetyReporting object

Responsible for AE reporting to CA

Sponsor

Sponsor must declare reportable events to

National CA
Competent Bodies of the Autonomous Communities

Reportable AEs

SUSAR (Suspected Unexpected Serious Adverse Reaction) in combination studies only
SADE (Serious Adverse Device Effect)

SUSAR being life-thereatening or leading to death must be reported

Within a max of 7d upon first knowledge (+ 8d for additional information)

All other SUSARs

Within a max of 15d upon first knowledge

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

Standard Reporting Form

(1) SAE reporting form MEDDEV 2.7/3
(2) For combination studies: SUSAR reporting form CIOMS-I (provided on the AEMPS website in section “Aclaraciones sobre la aplicación de la normativa de ensayos clínicos”)

Provision of Annual safety report mandatory

Yes

Guidance on AE reporting procedure

Combination studies: Detailed guidance and practical instructions are given in the document "Aclaraciones sobre la aplicación de la normativa de ensayos clínicos", published on the AEMPS website

Applicable national legal framework/ Reference

Royal Decree 1090/2015

Investigator shall report SAE to

Sponsor

Reporting timeline

Immediately (without delay)

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