CASafetyReporting object

Responsible for AE reporting to CA

Sponsor

Sponsor must declare reportable events to

National CA
Relevant EC(s)

Reportable AEs

SAE (Serious Adverse Event) likely to be related to the procedure of implementation of the MD
All suspicions of USADE (Unanticipated Serious Adverse Device Effect)

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

Immediately

SAE /SADE must be reported

Immediately, within a max of 15d for other reportable events (Suspicions of USADE + SAE likely to be related to the procedure of implementation of MD)
Immediately, for events bieng life-threatening or leading to death

National standard reporting form available

Yes

Standard Reporting Form

A standard reporting form ('Formulaire 5' & 'Formulaire 6') is available on the ANSM website in section: Activités > Dispositifs médicaux > Essais cliniques portant sur les dispositifs médicaux et dispositifs médicaux de diagnostic in vitro > Formulaires et modèles à télécharger (Forms and Downloads)

Available at : http://ansm.sante.fr/Mediatheque/Publications/Formulaires-et-demarches-Essais-cliniques

Reporting format - Options

Electronically
Exceptionally by post

Preferred format

Electronically

Provision of Annual safety report mandatory

Yes

Annual safety report shall be provided by sponsor to

National CA
Relevant EC(s)

Guidance on AE reporting procedure

"Avis au promoters/ Notice to sponsors': Provides detailed information reporting obligations including required contents and format of reports

Document available on ANSM website in section: Activités > Dispositifs médicaux > Essais cliniques portant sur les dispositifs médicaux et dispositifs médicaux de diagnostic in vitro > Avis aux promoteurs / fiches (Notice to sponsors/ guidelines)

Applicable national legal framework/ Reference

Article R. 1123-48 of the CSP
Decree EI (articles 4 and 8)
Article R. 1123-53 of the CSP (Annual Safety Report)
Decree : Décret n°2017-884 du 9 mai 2017 modifiant certaines dispositions réglementaires relatives aux recherches impliquant la personne humaine

Additional Information

These provisions apply to interventional clinical trials carried out on MD and IVD MD

Investigator shall report SAE to

Sponsor

Reporting timeline

Immediately

Sponsor is obliged to notify all investigators of SAE/ SADE occurrence

Yes

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