Protocol-specific data elements

Protocol-specific data elements are the data elements collected by a study that are important to the protocol but are not considered Common Data Elements (CDEs). In fact, in some cases the most important variables collected by a study may not be CDEs.

Examples of protocol-specific data elements are those pertaining to how a therapy being studied is administered or data elements that comprise a new disease-specific quality of life assessment that is being developed.

Sourced From
National Institute of Neurological Disorder and Stroke (NINDS): Classifications of Data Elements for a Particular Disease