ECSafetyReporting object
The definitions of Article R.1123-39 of the CSP apply.
SAE (Serious Adverse Event)
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)
Any new event which could have an unfavourable impact on participants’ safety or on the method of trial
Sponsor
Immediately
Sponsor
Immediately, within a max of 7 d upon first knowledge (+8d for additional information) for reportable events being life-threatening or leading to death
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)
Yes
Use of corresponding form (for AE reporting to CA) possible
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)
Yes
(1) Fiche: "Schéma de déclaration des données de sécurité à l'ANSM et au CPP": A summary table of the safety data to be declared to ANSM and the CPP concerned,
(2) "Avis au promoters/ Notice to sponsors': Provides detailed information reporting obligations including required contents and format of reports
Both documents 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)
Semi-annually report: a list of suspicions of USADE and adverse events likely to be related to the procedure of implementation of the MD which have occurred outside national territory in the trial concerned.
All these provisions apply to interventional clinical trials carried out on MD and IVD MD
