FIG. 2.

Pre-clinical Traumatic Brain Injury (TBI) Common Data Element (CDE) Groups and Form Structure Procedure. The CDEs are described by a set of attributes (left) that described the data element, inform the user about the input format and permissible values, units of measure and similar information necessary to ensure consistent data entry. In addition, there are instructions, guidelines, and references as appropriate. CDEs are organized into several groupings, shown in the center. The Main Group is intended to go on every form and considered essential to every pre-clinical study. The Animal and Study Metadata includes groups on Animal History, Animal Characteristics, and All Tests Common. The Injury Models CDEs are organized by injury model type, but forms may contain other elements, such as Animal History and All Tests Common. Form Structures can then be built from the various groups of CDEs. For example, a FS for a study that uses fluid percussion injury and Morris water maze would be built from the building blocks in the various forms. Color image is available online.