1 System Overview
Oracle Clinical is a database application that streamlines clinical trial management. It provides tools to manage all of clinical trial activities from your organizational infrastructure to preparing your results for submission. The foundation of the application is a flexible data model with the following features:
- A Global Library of reusable objects
- A comprehensive set of tools for capturing the components of the clinical trial protocol
- A flexible method for structuring the questions that appear on Case Report Forms (CRFs)
- Automated procedures for generating and customizing data entry windows (forms) that correspond to the CRFs
- Tools to define complex data validations and derivations that require little or no programming
- A discrepancy database automatically synchronized with changes to both the clinical trial data and the validation definitions
- A flexible internal data structure for storing the clinical trial data that provides the ability to reorganize data for extract
- Tools to maintain lab reference ranges across multiple studies
Oracle Clinical's Main Parts
At the highest level, Oracle Clinical is organized around seven major clinical trial activities. There is a navigation aid for each of these activities in the application's navigation panel. These are the menu items:
- Design
- Definition
- Conduct
- Extract
- Administration
- Lab ranges
- Global Library
The following sections summarize the functions of each of the major subsystems that comprise the top level of Oracle Clinical's navigation panel: