Data element (DE)
A Data Element (DE) refers to the information that describes a piece of data to be collected in a study. The DE does not include the data themselves. A DE has a name, precise definition, the question or query used to ask for the information, any added instructions to the participant about how to answer the question, and a set of clear responses or choices (enumerated values or codes). DEs may also include information about how the DE was developed and evidence of scientific validity.
An example of a DE is race, where a study participant is asked to choose which racial category or categories they identify with. The race data element generally consists of the following categories, which are the permissible values/responses: American Indian or Alaska Native, Asian, Black or African-American, Native Hawaiian or Other Pacific Islander, and White.