FDA04
Data Definition Tables – Definition and Automation
Matthew J Becker, PharmaNet, Inc.
Kitty Moses, Microcebus, Inc.

Successful FDA submissions contain a number of items. For Biostatistical personnel, one of these items is a set of data definition tables (DDTs). Three types of data definition tables are needed for a submission: a list of all data sets and what they co ntain (eg: Adverse Events, Demographics, etc.); an alphabetical list of variables and the data set(s) they reside; a list of all variables, variable type, variable format, and algorithm if they are derived, by data set for the entire database. We have ta ken a step towards automating the generation of the DDTs for a submission. We will discuss the components and process used to arrive at the ultimate goal: automated DDTs!