ABSTRACT
An interactive voice response system (IVRS) is, in its simplest form, a telephone system designed to collect patient demographic information during the screening or randomization event for each patient enrolled in a clinical drug trial. The base technology itself is quite simple. A telephone is required to call into a centralized database, which is programmed to accept the phone call, request access, or user information, and allow the caller to complete predefined transactions designed in the IVRS protocol. The demographic information collected is written to a project database and can provide real-time information about the status of patient randomization and overall global enrollment activity. Data points valuable to track enrollment (i.e., patient initials, eligibility criteria, age, gender, and weight) can be collected to assist in the management of centralized randomization. Patient numbers are stored in the project database and are given to the caller at the end of the
randomization transaction. Some systems may be designed to collect patient numbers (screening/randomization) from study sites. Dispensing patient numbers through the IVRS, however, ensures the study sites will call the IVR system at every enrollment transaction, thus increasing compliance and accuracy of clinical trial management information.
