Abstract
A unique feature of the International Verapamil SR/Trandolapril Study (INVEST) is the Internet‐based, electronic data capture system developed at the University of Florida for this trial. This system allows for direct collection of patient enrollment data, randomization, study drug prescribing, and real‐time monitoring of patient data online. In this trial, immediate transmission of patient‐specific data occurs using online data collection forms. Investigators only need a personal computer with access to the Internet; no complicated hardware, software systems, or paper storage files are necessary. INVEST is the first large randomized clinical trial to use electronic prescribing systems in the research setting. Electronic prescribing eliminates errors associated with illegible handwriting, inappropriate dosing, and inappropriate medication choice. Because the INVEST protocol allows flexibility of medication choice and dosage range within randomly assigned treatment strategies based on patient tolerance and blood pressure response, physician investigators may use individual practice patterns and preferences. The electronic system provides guidance to physicians relative to the addition of medication or dosage adjustments within the protocol. Electronic tracking and reporting mechanisms have enabled investigators in this complex megatrial to enroll, randomize, and manage patients in real time with great accuracy.
Keywords: central drug distribution, clinical trials management, electronic prescribing, enrollment, INVEST, pharmacy, randomization
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