Non-interventional Post-Authorisation Safety Studies (NI-PASS): A different type of report

Greg Morley
2014 Medical Writing  
Although Post-Authorisation Safety Studies (PASS) have been around since 2001, most regulatory writers would have been unaware of their existence until the recent changes in European regulations, which include mention of these studies as part of general strengthening of pharmacovigilance procedures. Interventional PASS will largely adhere to International Conference on Harmonisation requirements, but non-interventional (NI) PASS should be reported according to a particular mandated format,
more » ... may appear strange to writers used to drafting clinical study reports for interventional trials. Given their novelty, there is no consensus as to how these reports should be drafted. This article addresses the structure of NI-PASS reports and provides an interpretation, albeit preliminary, of the corresponding European Medicines Agency guidance text.
doi:10.1179/2047480614z.000000000253 fatcat:soyd5vf5gjfa7gmdzl5xd53zqi