Overview of Easy Study Design

Oracle Clinical's Easy Study Design window provides a simplified method to create a live version of a study. From this single window you can access streamlined versions of the main design utilities: planned study, clinical study, Intervals, events, patterns, and patient positions. After completing these essential components, you can refine the details of your study with any of the standard design forms.

For more information, see:

• Requirements
  
• Using Easy Study Design
  
• Data Structure Compatibility
  
• Querying a Study
  

Requirements

You can create a new study using Easy Study Design only under one of the following conditions:

• No planned study and no clinical study exists with the study name.

• A planned study exists with the study name, but no clinical study exists with the study name. (To plan a study, from the Plan menu, select Planned Studies.)

• A clinical study with the study name exists, but no versions exist.

After initial setup, you can use any of the standard design forms to add or modify other objects for your study. You can modify any object that originates in Easy Study Design with the equivalent standard design window, with these limitations:

• You can add new objects created with standard design forms.

• You cannot necessarily modify objects that originate in standard design forms as replacements for Easy Study Design objects.

• Some standard design-created objects include fields not available in the equivalent Easy Study windows. The system does not make these objects available to the equivalent Easy Study Design window. You must use standard design forms to access these objects.

Using Easy Study Design

There are five design functions available from Easy Study Design: clinical studies, planned study Intervals, clinical planned events, treatment patterns, and patient positions. You can use Easy Study Design to create all these components, some of them, or none of them.

Since the purpose of Easy Study Design is to provide a faster means of creating live studies, the window sets its version to live. In fact, you can only access studies with live versions in the Easy Study Design window.

Data Structure Compatibility

The structure of the data created by Easy Study Design is consistent with the data created by the standard study design modules. This means that studies created in Easy Study Design are accessible in the standard study design forms.

For instance, you can modify the clinical planned events for a study created in Easy Design via the Maintain Clinical Planned Events window. However, the same is not generally true working the other way: Objects created through standard study design forms are not always accessible from Easy Design. Because many fields are not accessible through Easy Study Design windows, if you want to modify studies that have data in these fields, access the data through standard study design forms.

Querying a Study

When you query in Easy Study Design, the system only returns its live version. A study created through the standard clinical studies modules can be queried in Easy Study Design only if it has a live version.