Use of a Remote Computerized System for Study Documentation in Clinical Trials
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0092-861598 Copyright Q 1998 Drug Information Association IN.
USE OF A REMOTE COMPUTERIZED SYSTEM FOR STUDY DOCUMENTATION IN CLINICAL TRIALS MARKS. JONES, MBA Chief, Automated Data Rocessing Section
DENNISW.
RAISCH,
RPH, PHD
Associate Center Chief
DAVIDGARNAND, BS Programmer, Automated Data Rocessing Section
MIKER. SATHER,MS, FASHP Center Chief Cooperative Studies Program, Clinical Research Pharmacy Coordinating Center, Department of Veterans Affairs, Albuquerque, New Mexico
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 incorporationof labjindings. Drug accountability is provided through daily monitoring of shipments and drug usage. This paper describes RDTIS, with an overview of the hardware and sojhare 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. Key Words: Bar code technology; Clinical trial; Automation; Computerization; Drug administration
INTRODUCTION
care, including inventory control and health services documentation (1). When data need THE USE OF BAR ‘ODE is to be accurately and completely monitored, rapidly increasing in all aspects of health bar codes offer the capability to accomplish this task. Thus, the application of bar code technology in clinical trials may offer speReprint address: Mark s. Jones. MBA, Chief, Auto- cific advantages.A recent documented mated Data Processing, Cooperative Studies Program. the Of using bar coding forpatient Clinical Research Ph-acy Coordinating Center, Department of Veteran Affairs, 2401 Centre s.E.,A h - enrollment and documentation of blood S a m querque, NM 87 106. ples in a clinical trial (2). This manuscript 1153
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M. S. Jones, D. W.Raisch, D.Gamand, and M. R. Sather
describes a system that uses bar code technology in clinical trials. The application of this technology extends from drug administration verification and drug dosing documentation to posting of laboratory results and patient outcome documentation. The Veterans Affairs (VA) Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CRPCC) provides pharmaceutical support services for multicenter clinical trials conducted within and outside the VA. This support extends from the planning through close-out phases o
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