The EU obligations to companies sponsoring a post-authorisation study (PAS) are specified in Module VI of the Guideline on good pharmacovigilance practice (GVP) - Management and reporting of adverse reactions to medicinal products. For a non-interventional PAS which is not sponsored by an MAH there are no legal reporting obligations at the European level. Investigators should however enquire whether national obligations exist. In all circumstances, the adverse events/adverse reactions reported during the study should be summarised in the study report. If the study qualifies as an interventional trial, the reporting criteria laid down in Directive 2001/20/EC and Volume 10 of the Rules Governing Medicinal Products in the European Union should be followed.
Obligations or recommendations may also be specified by an ethical committee or a data safety monitoring board. The Guidelines for Submitting Adverse Event Reports for Publication (Pharmacoepidemiol Drug Saf 2007;16(5): 581–7) introduce readers to the key elements that have to be included when someone wishes to publish results about adverse drug events. For a case report (or series), minimum requirements include an account of the patients medical history and disposition, a detailed account of the dispensed product (substances, brand, route of administration) and a detailed account of the adverse event (nature, timing, severity, outcome).
|Annex 1.||Guidance on conducting systematic revies and meta-analyses of completed comparative pharmacoepidemiological studies of safety outcomes|