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Example from Crohn's WP1 Disease Classification Module, which is still under discussion.  Below is an abbreviated example showing the direction in which we seem to be heading, with the "Using Location Variables" section added as an afterthought.


As part of the screening visit, this study collected the patient's history of CD. Some information was provided directly by the patient, and other information was obtained from the subject's medical records. MHCAT was used to delineate between more general CD questions and those that pertain to extra-intestinal manifestations (EIM). MHTERM was assigned by the sponsor using the appropriate MedDRA Lowest Level Term (LLT), when available. MHDECOD was reported as the MedDRA Preferred Term. Note: Upper gastrointestinal CD is currently not as MedDRA LLT. If required, sponsors may request new terms be added to MedDRA (see https://www.meddra.org/how-to-use/change-requests). 

 mh.xpt
Rows 1-7:Not shown.
Row 8:Shows that subject CR001-001 had pyoderma gangrenosum as an EIM.

mh.xpt

RowSTUDYIDDOMAINUSUBJIDMHSEQMHLNKIDMHTERMMHDECODMHLLTMHCATMHPRESPMHOCCURMHLOCVISITNUMVISITMHDTC
8CR001MHCR001-00184Pyoderma gangrenosumPyoderma gangrenosumPyoderma gangrenosumEXTRA-INTESTINAL MANIFESTATIONYY
1SCREEN2010-01-01

The sponsor collected details findings about specific events or diagnoses. These findings were represented in the Findings About (FA) domain and were linked to the MH record via --LNKID. FAOBJ was assigned using MHDECOD. 

 famh.xpt
Row 5:Shows the number of pyoderma gangrenosum lesions.
Row 6:Shows the location of the primary lesion of pyoderma gangrenosum.
Row 7:Shows the longest diameter of the primary lesion of pyoderma gangrenosum.

famh.xpt

RowSTUDYIDDOMAINUSUBJIDFASEQFALNKIDFATESTCDFATESTFAOBJFAORRESFAORRESUFASTRESCFASTRESNFASTRESUFALOBXFLVISITNUMVISITFADTCFADY
5CR001FACR001-00154LESNUMNumber of LesionsPyoderma gangrenosum2
22
Y1SCREEN2010-01-01-3
6CR001FACR001-00164PLLOCLocation of Primary LesionPyoderma gangrenosumSKIN OF THE KNEE
SKIN OF THE KNEE

Y1SCREEN2010-01-01-3
7CR001FACR001-00164PLLDIAMLongest Diameter of Primary LesionPyoderma gangrenosum30mm3030mmY1SCREEN2010-01-01-3

The RELREC dataset shows that some details of what is in MH are shown in the FAMH dataset and are linked via --LNKID.

 relrec.xpt

relrec.xpt

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1

CR001

MH


MHLNKID


ONE

1

2

CR001

FAMH


FALNKID


MANY

1

Using Location Variables

 famh.xpt
Row 5:Shows the number of pyoderma gangrenosum lesions.
Row 7:(Option 1: red, AMBIGUOUS) I examined the skin of the knee and found that the longest diameter of the primary lesion was 30mm. This could be interpreted to mean that other locations might also have primary lesions.
Row 7:(Option 2: yellow) The longest diameter of the primary lesion of pyoderma gangrenosum was 30mm and this result was obtained from the skin of the knee.

famh.xpt

RowSTUDYIDDOMAINUSUBJIDFASEQFALNKIDFATESTCDFATESTFAOBJFAORRESFAORRESUFASTRESCFASTRESNFASTRESUFALOCFALOBXFLVISITNUMVISITFADTCFADY
FARESLOC
5CR001FACR001-00154LESNUMNumber of LesionsPyoderma gangrenosum2
22

Y1SCREEN2010-01-01-3

7CR001FACR001-00164PLLDIAMLongest Diameter of Primary LesionPyoderma gangrenosum30mm3030mmSKIN OF THE KNEEY1SCREEN2010-01-01-3

7CR001FACR001-00164PLLDIAMLongest Diameter of Primary LesionPyoderma gangrenosum30mm3030mm
Y1SCREEN2010-01-01-3
SKIN OF THE KNEE

FAMH NSV Metadata

But what do you do if you need the location and longest diameter is not collected...?