CASafetyReporting object

Responsible for AE reporting to CA

Sponsor

Sponsor must declare reportable events to

National CA

Reportable AEs

SAE (Serious Adverse Event)
SUSAR (Suspected Unexpected Serious Adverse Reaction)

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

National standard reporting form available

Only for reportable events occurring in the respective country

Standard Reporting Form

(1) Notification form in paper for SUSARs occurring in Spain:
Use of the standard reporting form provided on the AEMPS website in section “Aclaraciones sobre la aplicación de la normativa de ensayos clínicos”: Anexo D: Formulario de notificación de reacción adversa grave e inesperada ocurrida en España
Notifications on any SUSARs occurring in Spain shall be in Spanish.
(2) International standard form for SUSARs occurring outside Spain.

Reporting format - Options

Paper hardcopy
Electronically

Preferred format

Electronically

Provision of Annual safety report mandatory

Yes

Annual safety report shall be provided by sponsor to

National CA + the competent bodies of the concerned Autonomous Communities

Guidance on AE reporting procedure available

Yes

Guidance on AE reporting procedure

Detailed guidance and practical instructions are given in the document "“Transmisión electrónica de sospechas de reacciones adversas de medicamentos de uso humano / Electronic transmission on suspected adverse reactions with human use medicines"

Applicable national legal framework/ Reference

Royal Decree 1090/2015 (Article 49)

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