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EMA Refelection paper on IVR/IWR systems
In the recently published EMA Reflection paper on IVR/IWR (Interactive Voice/Interactive Web Response) systems, an additional QP Declaration is introduced for managing expiry dates.
As IVR/IWR systems are developed to facilitate overall drug management and expanded to assist with dose titration, unblinding and expiry date update, the intent of the paper is to provide guidance to the sponsors and to the IVR/IWR providers in the use of the systems within clinical trials and detail the expectations of the National Competent Authorities on such systems.
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.
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)
Zum Dokument:
Titel: Reflection paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials
Referenz Nr: EMA/INS/GCO/600788/2011
Status: Draft zur Kommentierung
Letztes Update: 11.8.2011
Kommentierungsende: 15.2.2012
Kommentare bitte an folgende E-Mail Adresse:
gcp@ema.europa.eu
Summary:
Summary
As IVR/IWR systems are developed to facilitate overall drug management and expanded to assist with dose titration, unblinding and expiry date update, the intent of the paper is to provide guidance to the sponsors and to the IVR/IWR providers in the use of the systems within clinical trials and detail the expectations of the National Competent Authorities on such systems.
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