1 Overview of Creating a Study
This manual covers the study design process from the initial organization planning stage to the active study stage.
Oracle Clinical organizes the study creation process into several subsystems. The subsystems correspond to a progressively maturing protocol. They parallel the stages of clinical study creation, from the general features common to all studies to features specific to modeling one protocol for one study.
However, the tasks in creating a study are iterative, nonsequential, and often performed by more than one individual or team, so Oracle Clinical's modular subsystems enable your company to develop different parts of a study concurrently. The general stages for creating any study in Oracle Clinical, (with the corresponding subsystems in parentheses) are:
-
Program and project definition (the Plan subsystem)
-
Study definition (Design)
-
Defining data collection objects (Glib and Definition)
-
Testing (Design)
The following sections describe the tasks required in each of the major and minor subsystems of Oracle Clinical to create a study: