The term post-authorisation studies may include various systems of organised data collection, which do not fall under the definition of clinical trials – this includes PASS, patient programmes and registers, patient support programmes for patients with a specific disease and patient and physician questionnaires. If information is sought actively (by the study sponsor, register operator, etc.) within the terms of these systems, potential resulting reports are considered solicited reports. These are always classified as reports “From the study” (not spontaneous). In such cases reports of suspect adverse drug reactions are reported to the EudraVigilance database only if it is probable that the adverse reaction is related to the suspect MP within the terms of the study.
This causality is identified in the section titled Drug Reaction Relatedness (B.4.k.18) in the electronic report format E2B R2 or in the section Assessment of Relatedness of Drug to Reation (G.k.i.2.r.) in the format E2B R3, and this field should be completed for all reports “From the study”.
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