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Dataset wrap
titlecv.xpt
Namecv


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Row 1:I examined the MRI image of the thoracic region (test location) and didn't find the presence of an aneurysm.
Row 2:I examined the MRI image of the abdominal region (test location) and found an aneurysm in the left (Result LAT) renal artery (Result Loc).
Row 3:I examined the image of the abdominal region (test location) and found an aneurysm in the infrarenal aorta (Result Loc).
Row 4:I measured the diameter of the aneurysm in the left renal artery (test location).
Row 5:I measured the diameter of the aneurysm in the Infrarenal Aorta (test location).



Dataset2


Row

STUDYID

DOMAIN

USUBJID

CVSEQ

CVGRPID

CVTEST

CVORRES

CVORRESU

CVLOC

CVLAT

CVMETHOD

VISITNUM

VISIT

CVDTC


CVRESLOC
CVRESLAT
1ABCCVABC-4561
Aneurysm IndicatorN
Thoracic Region
MRI1BASELINE2020-04-27


2

ABC

CVABC-45621Aneurysm IndicatorY
Abdominal Region
MRI1BASELINE2020-04-27
Renal ArteryLeft
3ABCCVABC-45632Aneurysm IndicatorY
Abdominal Region
MRI1BASELINE2020-04-27
Infrarenal Aorta
4ABCCVABC-45641Aneurysm Diameter3cmRenal ArteryLeftMRI1BASELINE2020-04-27


5ABCCVABC-45652Aneurysm Diameter5cmInfrarenal Aorta
MRI1BASELINE2020-04-27

I think what SDTM has not addressed with imaging results is that when you look at the images produced by a procedure, and if your task it to look for the occurrence of a suspected object, what should be considered as the anatomical location of the TEST since you are looking at a 2-dimentaional image/picture. My take is that the images are still representative of, and are about a specific section or part of the body, it allows you to view the entirety of a section or part of the body. In other words, you are looking for a suspected object within a section/part of the body that is made visible to you by the diagnostic procedure. So applying this logic, I outlined the modeling for coronary occlusion data.

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Lastly, i suppose you could represent aneurysms, arterial dissection, coronary occlusion all as clinical events and use the FACE structure, although i think they are findings about cardiovascular system so CV is a better place for them. However using FACE I have arrived to the same conclusion, see below. What's interesting about the concept map below is that it further shows how anatomical location values vary in --LOC depending on the SDTM class the data go into. As you summarized:

1. Anatomical focus of an intervention - at which part of the body an intervention is being made. (PR)

2. Anatomical manifestation of an event - the part of the body which shows a sign of the event occurring. (CE)

3. Anatomical object of an observation - about which part of the body is the observation being made. (FA/CV)

This shows me that a single --LOC variable for three classes, is an issue.

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