Database Development of a Clinical Trial

Abstract

Clinical trials, conducted in the United States and throughout the world, have developed through the years using detailed study designs intended to extract as many data as possible in determining the safety and efficacy of a drug compound. With the increase in patient populations and time courses of these drug studies also comes an increase in the number of data collected for analysis. It is therefore essential that the database for any clinical trial assures the integrity of these data, meets compliance standards for audit purposes, and conforms to the time parameters dictated. Database creation is a stepwise process involving encoding of the case report form data, establishing a data entry routine, data entry/verification, and transfer of data to memory for future retrieval. This article will discuss methods employed in creating a database that can ensure an accurate clinical trial.