Voice response

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. 

Automated randomization systems have been developed using voice response [44] and telephone touch-tone technology [45,46]. Others have used a preloaded password-protected system with hidden encrypted randomization files into the trial s laptop or desktop computers that are used as distributed data collection devices [47] or have developed centralized computer programs that dynamically randomize subjects [48]. 

Jones MS, Pontzer JF, DelCurto B, Badgett CA, Sather MR. Integrating interactive voice response system and web based systems to support home international normalization ratio testing. Clin Trials 2005 2 S73. 

Assman SF, Bodnya A, Smith SS, Tighe F. An interactive voice response system for randomizing subjects. Controlled Clin Trials 1996 17 2 S68-S69. 

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)... 

When initially describing the system context, we avoid describing UI specifics, because these can vary. Detailed interactions via the user interface are better treated as a refinement of the abstract use cases that are being carried out. The basic MVC architecture applies to many forms of user interfaces, including graphical, character-based, touch screen, and voice-response. 

O Shea K. Interactive voice response technology. Appl Clin Trials 1998 7 30-4. 

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 ... 

Feltner, D.R., Kobal, K, Crockatt, J., et ah Interactive voice response (IVR) for patients screening of anxiety in a clinical drug trial. NCDEU Poster Abstracts, www.nimh.nili.gov/ncden/ahstraets2001. 

Interactive Voice Response Randomization Systems Analytical Instrumentation SOP Management... 

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. 

Interactive video-based instruction, 928 Interactive voice response technology (IVR), 658... 

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