Commission Implementing Regulation (EU) No 520/2012

means the date from which the analytical dataset is completely available.

means information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, which is judged to be of sufficient likelihood to justify verificatory action.

means the process of evaluating the data supporting the detected signal in order to verify that the available documentation contains sufficient evidence demonstrating the existence of a new potentially causal association, or a new aspect of a known association, and therefore justifies further analysis of the signal.

means the date from which information on the first study subject is first recorded in the study dataset or, in the case of the secondary use of data, the date from which data extraction starts;