40 KlinV :
Falls gemäss Protokoll nicht anders vorgesehen SAE mit Todesfolge innerhalb von 7 Tagen ( an lokale EK nur lokale Ereignisse , an Leit-EK alle Ereignisse in der CH ) . Verdacht auf eine unerwartete schwerwiegende Arzneimittelwirkung ( Suspected Unexpected Serious Adverse Reaction , SUSAR ) Siehe Art .
41 KlinV:
www.swissethics.chwithin one year of completion or discontinuation Serious adverse events ( SAEs ) in clinical trials of medicinal products See Article 40 KlinV-ClinO :
Unless otherwise specified in the protocol, SAEs with fatal consequences within 7 days (to the local EC for local events, to the responsible EC for all events in Switzerland).
Suspected unexpected serious adverse reactions, SUSARs) See Article 41 KlinV-ClinO:
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