Computer-Assisted Clinical Research

Abstract

Clinical research needs to be conducted in a timely manner and to the standards of good clinical practice (GCP). If using computerized systems, then good manufacturing practice (GMP) draft guidelines need to be followed. Trax Research is a small clinical research organization which aims to provide combined clinical and statistical reports to GCP and GMP standards within 28 days of study completion using an integrated personal computer-based approach.

A project management package is used to establish the client contract and manage the research. Data entry screens are designed using a database management package and case report forms (CRF) with identically matching screens generated using a desk top publishing package. The protocol and appendices are then assembled using a word processor. A notebook computer is either carried by the field monitor or installed at the investigator's site and data downloaded to Trax Research using a communication package. The descriptive part of the statistical analysis is preprogrammed using a statistics package so that analysis of the study can be completed within two weeks of study completion. A graphics package is used to simultaneously generate figures for the report, overhead transparencies, and 35mm slides for audio-visual presentation.