FDA01
Clinical Data Model and FDA Submissions
Shy Kumar, Datafarm, Inc.
Gajanan Bhat, Boston Scientific Corporation

Development of data model in clinical trial management environment is an ongoing process but of utmost importance for a good clinical information management. Companies are trying to come up with efficient global standards in data modeling to work with. G lobal standards are also important and imminent in view of the new electronic submission guidelines of Food and Drug Administration (FDA) for New Drug Application. Most important factors to consider when designing the analysis and reporting data structure are standard data structures, metadata, documentation, and data normalization. The main objective of this paper is to provide a data model that will make FDA submission more efficient in new drug approval process. The paper discusses specific areas such as developing data model, features of data model, defining source data structures, defining derived variables, and also discusses the strengths and weakness of this modeling approach.