EMA: Reflection paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials.

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.