Example 1: Project Domain with Reporting on Separately Stored Study Data

Alternatively, you can keep each study's data separate throughout the process except to report on the project as a whole. Within each project Domain, create the following child Domains:

• A Domain for Each Study. Load data for each study in the project into an Application Area in its own Domain. Create a Load Set from the source tables or data sets. Oracle LSH stores the Load Set definition in the Application Area library.

  If you collect data for different studies using slightly different formats, define a Program to copy raw data into Table instances with a standard data type and length for the project. Create an instance of the Program for each study, mapping its source table descriptors to the appropriate raw data table instances.

  Create Report Sets and run each of them on the standardized study data. If necessary, create a different version of the Report Sets for each study.

  When you are ready to unblind study data, run the Report Sets in Unblind mode or unblind each Table instance.

• A Domain for Projectwide Data and Reports. Define a Program to copy data from the standardized table instances for each study into a single set of table instances for the project.

  Run the Report Sets for the project as whole. If necessary, create a new version of each Report Set for the projectwide data.

  When all studies are unblinded, run the Report Sets in unblinded mode or unblind each Table instance and then run the Report Sets.

Figure 3-3 Organizational Structure for Example 2, with Data Flow