CDISC-Gloss – The specific clinical circumstance or purpose for which a medical product or test is being developed. NOTE: In the regulatory context, this term refers to the “Statement of Intended Use” prepared by the persons legally responsible for the labeling of medical products. [after NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/]