+DE.AE-08 Incidents are declared when adverse events meet the defined incident criteria

DE.AE-08 Incidents are declared when adverse events meet the defined incident criteria

Statement

Incidents are declared when adverse events meet the defined incident criteria

Guidance

Apply incident criteria to known and assumed characteristics of activity in order to determine whether an incident should be declared

Guidance

Take known false positives into account when applying incident criteria

1. Overzicht

Titel Standaard

1.1 Referenties

1.2 Geïdentificeerde eisen

1.3 Gerelateerde regelingen

2. Geïdentificeerde eisen

Eisen
Bron Eis

3. Gerelateerde regelingen

Regelingen
Bron Regelgeving

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