IVRS Interactive Voice Response System

The randomization of a patient in a given therapy is the cornerstone of a randomized clinical trial. You may find these data in more than one place. They are often found within some form of Interactive Voice Response System (IVRS), but they may also be found in an electronic file containing the treatment assignments or on the CRF itself. If randomization data are found on the CRF, they usually consist only of the date of randomization for treatment-blinded trials. IVRS data are often found outside the confines of the clinical data management system and usually consist of the following three types of data tables. 

Randomization data from an interactive voice response system (IVRS)... 

In central randomisation the randomisation process is controlled and managed from a centralised point of contact. Each investigator makes a telephone call through an Interactive Voice Response System (IVRS) to this centralised point when they have identified a patient to be entered into the study and is given the next allocation, taken from the appropriate randomisation list. Blind can be preserved by simply specifying the number of the (pre-numbered) pack to be used to treat the particular patient the computerised system keeps a record of which packs have been used already and which packs contain which treatment. Central randomisation has a number of practical advantages ... 

An Interactive Voice Response-System (IVRS) is a communications platform based upon the telephone network used to coordinate key clinical trial activities and provide real-time information for study managers. By utilizing the telephone network, the system provides for a direct connection between the clinical trial patient and the central study-specific database. This permits the collection of data in response to preprogrammed prompts from the system, ensuring the recording of key trial events and the provision of information critical to the successful conclusion of the trial. Most IVR systems are individually tailored to each specific study based upon requirements defined by the Sponsor. 

The telephone is also utilized in the development of interactive voice response (IVR) systems that support touch-tone or speech recognition responses. IVR systems have been developed for subject randomization, drug assignment, and survey data collection. 

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