This example SDTM dataset shows the anatomical sites of psoriasis lesions at the screening visit. In this study, disease sites were assessed as a whole, rather than individually, and were used by the sponsor to describe the extent of the subject disease at baseline. The Tumor/Lesion Identification (TU) domain was used to represent these sites of disease. The test, Lesion Identification, was used with a result of "DISEASE SITE" to indicate that these were the sites of disease identified for each subject. Note the result of "LOCATION OF INTEREST" is used only when that specific location will be individually assessed at subsequent visits. The general term "DISEASE SITE" is used to indicate a site that is present but which will not be individually evaluated during a study. The expected variable TULNKID was left blank because no other data about these disease sites were represented in the Tumor/Lesion Results (TR) domain.
|1||PS002||TU||001||1||LESIDENT||Lesion Identification||DISEASE SITE||DISEASE SITE||SKIN OF THE BENDING JOINT||PHYSICAL EXAMINATION||Y||INVESTIGATOR||1||SCREEN||2010-01-01||-3|
|2||PS002||TU||001||2||LESIDENT||Lesion Identification||DISEASE SITE||DISEASE SITE|
|3||PS002||TU||001||3||LESIDENT||Lesion Identification||DISEASE SITE||DISEASE SITE|
SKIN OF THE UPPER LIMB
|4||PS002||TU||002||1||LESIDENT||Lesion Identification||DISEASE SITE||DISEASE SITE|
SKIN OF THE LOWER LIMB
|5||PS002||TU||003||1||LESIDENT||Lesion Identification||DISEASE SITE||DISEASE SITE||SKIN OF THE TRUNK||LEFT||ANTERIOR||PHYSICAL EXAMINATION||Y||INVESTIGATOR||1||SCREEN||2011-01-01||-4|