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Monitoring Interactive Response Technology Vendor Implemented Randomization and Dosing Systems

Primary: Jason A. McCoy
Author(s): Jason A. McCoy Venkat
Amgen, Inc. Mandarapu

SCT Annual Meeting 2018

Abstract:
Use of Interactive Response Technology (IRT) vendor-implemented randomization and dosing algorithms is an effective method to reduce the incidence of medication errors in the clinical trial setting. However, errors in the programming of randomization and dosing algorithms remains a risk factor leading to medication errors for subjects on a clinical trial. Hence, vendor oversight is important in reducing risks for subjects participating in clinical trials. Additionally, regulatory agencies have maintained that it is ultimately the sponsor’s responsibility to maintain oversight of IRT vendor’s systems used in their clinical trials. We describe a method for improved monitoring of Interactive Response Technology vendor implemented randomization and dosing systems shortening detection time and reducing impact of system errors. To augment best practice IRT system testing and vendor oversight activities, we have developed a process which enables a sponsor to continuously monitor randomization and dosing algorithms such that the sponsor will become aware of potential IRT-caused dosing discrepancies within 24 hours of first occurrence, limiting the potential for a systematic error to impact a large number of subjects. Implementing this process represents an important step in ensuring subject safety and the validity of clinical trials.

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