Patient Randomization basically includes three major fields – Subject (patient) Recruitment, Informed Consent, Schedule Randomization and Subject History.IVRS(Interactive Voice Response System) assists a faster and flexible way in the registration of a subject. Moreover IVRsystem can avail remote site randomization of new Subject at any time.
In subject recruitment, through IVRS, subject can telephone a toll-free number and answer a series of questions to determine their potential eligibility to participate. If IVRS finds the subject is eligible then it record subject details and store the information into database and those failing will be given information about how to seek further advice for their condition. Then IVRS generates an automatic alert to inform the study site or trained telephone caller to contact the subject. IVRS provides a centralized application and database that is beneficial for making changes in subject information during the study. Further for randomized patients, schedule is randomized according to the availability and the patients are informed regarding the same.
Making enrollment both more predictable and more efficient is a major quality benefit, as recruitment is the one of the activity involved in the study least in the control of sponsor.