Standard vs. study-specific content
This guide provides instructions on how to use the standard (non-customized) version of IRT. However, many sponsors customize some aspects of the application, such as:
- The terminology you use to refer to certain aspects of the interface, such as the options on the main menu.
- The terminology you use to refer to certain concepts, such as drug units, site, or depot.
- The prompts you see when you log subject information during a visit.
- The manner and degree by which IRT makes use of the Approvals system.
- The specific policies and procedures of the study or site.
If requested by the sponsor, Oracle develops study-specific guides that are available from the Home page. For more information, see Opening the study documentation.
The study-specific guides contain instructions that describe how IRT is set up for your study. The standard documentation provides a broader, more in-depth view of the product than you are likely to find in the brief study guides.
You should use the study guide to get started and to learn how IRT has been customized for your study. Use the standard documentation, such as this guide and the Administration Guide, for more detailed information.