This wiki contains the following pages:

These pages focus on Open Source adoption of the caDSR Database and Tools. The pages include information about ISO 11179 implementation extensions and software implementation architectures. For downloads, visit the Download Center.

caDSR Implementation Overview

The caDSR is based on an Oracle database. All of the various tools and interfaces connect to the same central database.

The software applications that access caDSR content are based on open source standards and are freely available for use by other government agencies and for download and use by interested parties.

caDSR follows the ISO/IEC 11179 standard to harmonize, register and integrate user-defined UML information models with existing and new caDSR content and to represent the CDEs in the database. This standard is somewhat complex, but it offers a richly expressive model for metadata that does a good job of supporting the variations needed for biomedical applications. If you are interested in working with the caDSR, review the background material on the way the ISO/IEC 11179 standard has been implemented.

In addition to implementing the ISO/IEC 11179 model, added a few additional types of content have been added to the caDSR. The two most important additional items are Forms and Protocols.

A Form is a collection of CDEs, and a Protocol is a collection of Forms. For clinical trials applications, the Forms correspond to Case Report Forms (CRFs), and Protocols correspond to a clinical trial protocol.

Template forms are generic forms that can be used as the basis for creating the actual forms used in a Protocol. Templates are stored both as a collection of CDEs that comprise the form, and an MS Word or PDF file that shows the CDEs laid out.