Over the last 15 years there has been an increasing utilization of interactive response technology (IRT), encompassing both interactive voice response systems (IVRS) utilizing the telephone or tone dialers and interactive web response systems (IWRS) utilizing the internet. These systems were developed initially to optimize drug availability at sites; however, this has expanded into other areas such as emergency unblinding (code-breaking), dose titration and expiry date updating. This of course may, if not handled appropriately, pose an increased risk to the patient and so IRT is of increasing interest to national competent authorities (NCAs).
This paper seeks to provide guidance on what NCAs expect from such systems and in particular their use for handling of the expiry date of the Investigational Medicinal Product (IMP). These positions will form suggestions for sponsors and IRT providers on the validation requirements for systems.
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