User Friendly Applications to Clinical Study Databases and Data Access

Abstract

Smith Kline & French uses a fourth generation database language because both the databases and data access programs can be modified quickly. Because we have such a powerful development tool, our clinical studies program is being developed at a rapid pace. Another tool used in support of clinical studies is a data dictionary package which fully defines all data files and data items. The primary uses of this dictionary are creating documentation and generating file descriptions of the clinical databases using a special dictionary interface. The dictionary also allows us to standardize data items and their definitions across several clinical studies. Smith Kline & French Labs is in the process of developing a standard way of collecting all clinical data items; however, these standards are not firmly defined. Our approach is to capture all the data required by the user. Since this is a new approach for us, the exact definition of what “all the data” is can never be finalized. We must allow our users to create...