Coordinating a Multicenter Trial Using a Microprocessor Based Clinical Research Data Acquisition System

摘要

The Epilepsy Branch (EB) of the National Institute of Neurological and Communicative Disorders and Stroke, National Institutes of Health, currently employs microprocessors to coordinate and monitor clinical trials data. Computer case report forms are used by nurse clinicians and data technicians on site to record specified patient information on floppy disks. The disks are then copied and sent to a registered nurse at the EB who intensively monitors the data. The computer case report forms must have clinical data that would identify abnormalities or possible trends leading to complications. The data collected must be adequate for a reliable analysis at the completion of the study and support further investigations. The forms were designed to be flexible and generalized for all antiepileptic drug clinical trials and require only minor changes to accommodate the specific needs of individual trials.