IVR/IWR Systems in Clinical Trials

Final text now issued

A final Reflection Paper on the use of Interactive Voice Recognition (IVR) and Interactive Web Recognition (IWR) systems in clinical trial study management was published in December 2013 and may be found here: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/12/WC500158536.pdf

In February 2014, EMA also published a document with all the comments received on the draft (including those from PQG) and this may be found here: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/02/WC500161984.pdf

There is an increased focus on the validation of the IRS and its role in the supply chain.

There has been no change in the thinking around when an IRS may be used to enable an expiry date to be omitted from labels, despite many comments back on this.