Use of a Remote Computerized System for Study Documentation in Clinical Trials

Abstract

In an effort to decrease the complexity of drug administration at the clinic site and increase automation in the packaging, distribution, and administration of clinical trial supplies, the Cooperative Studies Program Clinical Research Pharmacy Coordinating Center developed the Remote Drug Treatment Information System (RDTIS). This system uses bar code technology to assist in the verification of drug assignments, management of dose adjustments, and documentation of clinical doses. The system also assists the clinical site in the collection of adverse medical events, documentation of patient enrollments and terminations, and incorporation of lab findings. Drug accountability is provided through daily monitoring of shipments and drug usage. This paper describes RDTIS, with an overview of the hardware and software design, implementation issues, and issues relevant to clinical trial administration. RDTIS can assist in automating the collection of routine data through the use of bar code technology, help prevent dispensing errors, and assure the maintenance of the blind.