In the recently published EMA Reflection paper on IVR/IWR systems, an additional QP Declaration is introduced for managing expiry dates. Overall the "Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials" seeks to provide guidance to Member States on what the expectations are on IVR/IWR systems and in particular on their use in expiry updating. In the case such a system is used to control expiry dates, a declaration by the Qualified Person (QP) is needed. This declaration should be part of both the Product Specification File (PSF) and Trial Master File. Annex 1 of the draft document shows what this declaration should look like.
In addition, the sponsor will need to notify the QP of the validation status of the IVR/IWR system (and any audit the sponsor has undertaken).
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)