1. define.xml.v2 row-level metadata
documentation and example
Richard Senecal, Senior Principal Programmer
NJ CDISC Users Group
Merck/Summit, September 19, 2013

2. CDISC Define-XML Specification Version 2.0
Value Level Metadata sections
| Presentation Title | Presenter Name | Date | Subject | Business Use Only

3. what is the context? converting vertical files to horizontal
USUBJID
VSTESTCD
VSORRES
VSORRESU 1
HEIGHT 78
inches
DIABP 80
mmHg
FRMSIZE
MEDIUM
horizontal file
USUBJID
HEIGHT
HEIGHTU
DIABP
DIABPU
FRMSIZE 1 78
inches 80
mmHg
MEDIUM
| Presentation Title | Presenter Name | Date | Subject | Business Use Only

4. where does it live in define.xml?
page 12
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5. Codelists for VSTEST and VSTESTCD
page 29 and IE DEMO vs.vstest and vs.vstestcd
The VSTEST CodeList uses EnumeratedItems to store the list of possible values, as listed in the NCI/CDISC SDTM Controlled Terminology documents.
The VSTESTCD CodeList uses CodeListItems to reflect the association with VSTEST items.
| Presentation Title | Presenter Name | Date | Subject | Business Use Only

6. define version 1 vs version 2
page 34
define.v1 attached valuelist to –TESTCD and was assumed to describe the –ORRES only
define.v2 attaches valuelist to any variable:
--orres
--orresu
--stresc
--stresn
--stresu
| Presentation Title | Presenter Name | Date | Subject | Business Use Only

7. How the sections are chained together
pages
ItemGroupDef
has ItemRef for variables like VSORRES
ItemDef for VSORRES
has a def:ValueListRef pointing to a def:ValueListDef
def:ValueListDef
has ItemRefs for values of VSORRES (like DIABP)
in each ItemRef, there’s a def:WhereClauseRef
def:WhereClauseDef
has logic like: if VSTESTCD eq “DIABP”
| Presentation Title | Presenter Name | Date | Subject | Business Use Only

8. How the sections are chained together (cont...)
pages
ItemDef for the DIABP value in VSORRES
DataType="integer“
Length="2“
SASFieldName="DIABPOR“
Description=Diastolic Blood Pressure (Orig U)
def:Origin Type="CRF“
def:PDFPageRef PageRefs="11“
...
| Presentation Title | Presenter Name | Date | Subject | Business Use Only

9. Thank You !