Glossary

A data element which is commonly collected in clinical research studies but whose relevance depends upon the study design (i.e., clinical trial, cohort study, etc.) or type of research involved.

Examples of Supplemental CDEs are the Epilepsy CDEs related to electroencephalogram
(EEG) that are only relevant to epilepsy studies that use EEG for diagnostic purposes
and the Stroke CDEs related to administration of Tissue Plasminogen Activator (tPA) that
are relevant to acute ischemic stroke studies but not relevant to intracerebral
hemorrhage (ICH) studies.

A data element which is essential based on certain conditions or study types in clinical research studies. In most cases, these have been used and validated in the disease area. These data elements are strongly recommended for the specified disease condition, study type or design.