The majority of clinical trials generate a significant amount of data that has to be precisely recorded and later analyzed. Fortunately, there are a few open-source packages that provide both a powerful database and relatively low cost-point. Therefore, our presentation has a dual objective.

First, we will identify the unique data challenges presented by a clinical trial. The attendees will find that many of these challenges, and their solutions, can be applied to other projects and daily tasks. The second objective is to present an introductory level discussion on how to configure a database to record and analyze the data. We will include such topics as referential data integrity (RDI) and database normalization.

Finally, there is the need to both input the data and later analyze the data. We will discuss various methods of inputting data such as using custom desktop applications and also some Internet based applications. We will also present some reporting tools that are available and can be used to analyze their data and compile the desired results.