Table 1.
CDE category | Description |
---|---|
Core | Data elements that are essential and applicable to any SRC study. The NINDS and its appointed Working Groups assign the “Core” classification based on the current clinical research best practices. In each case, the SRC Core CDEs are a small subset of the available CDEs demonstrating appropriate test psychometrics specific to SRC. Core CDEs may be required for SRC studies. |
Supplemental–Highly Recommended | Data elements that are essential to specific conditions or study types in SRC clinical research studies. These elements have been used and validated in previous SRC research or specified SRC conditions, study types, or designs. Supplemental–Highly Recommended CDEs are strongly recommended for SRC studies. |
Supplemental | Data elements that are commonly collected in SRC clinical research studies, but with limited validation in previous SRC research. Use depends upon the study design, protocol or type of research involved. Supplemental CDEs are recommended for SRC studies. |
Exploratory | Data elements that require further validation but may fill current gaps in CDEs and/or substitute for existing CDEs as validation evolves. Such data elements show promise but require further validation before they are ready for use in SRC clinical research studies. Exploratory CDEs are reasonable for SRC studies, with the understanding that they have limited or no validation in SRC. |
CDE, Common Data Element; SRC, sport-related concussion; NINDS, National Institute of Neurological Disorders and Stroke.