Define xml v2 row level metadata
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define.xml.v2 row-level metadata. documentation and example Richard Senecal, Senior Principal Programmer NJ CDISC Users Group Merck/Summit, September 19, 2013. CDISC Define-XML Specification Version 2.0. Value Level Metadata sections. what is the context?.

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Define xml v2 row level metadata

define.xml.v2row-level metadata

documentation and example

Richard Senecal, Senior Principal Programmer

NJ CDISC Users Group

Merck/Summit, September 19, 2013


Cdisc define xml specification version 2 0

CDISC Define-XML Specification Version 2.0

Value Level Metadata sections

| Presentation Title | Presenter Name | Date | Subject | Business Use Only


What is the context

what is the context?

converting vertical files to horizontal

vertical file

horizontal file

| Presentation Title | Presenter Name | Date | Subject | Business Use Only


Where does it live in define xml

where does it live in define.xml?

page 12

| Presentation Title | Presenter Name | Date | Subject | Business Use Only


Codelists for vstest and vstestcd

Codelists for VSTEST and VSTESTCD

page 29 and IE DEMO vs.vstest and vs.vstestcd

| Presentation Title | Presenter Name | Date | Subject | Business Use Only

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.


Define version 1 vs version 2

define version 1 vs version 2

page 34

| Presentation Title | Presenter Name | Date | Subject | Business Use Only

  • 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


How the sections are chained together

How the sections are chained together

pages 35 - 40

| Presentation Title | Presenter Name | Date | Subject | Business Use Only

  • 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”


How the sections are chained together cont

How the sections are chained together (cont...)

pages 35 - 40

| Presentation Title | Presenter Name | Date | Subject | Business Use Only

  • ItemDef for the DIABP value in VSORRES

    • DataType="integer“

    • Length="2“

    • SASFieldName="DIABPOR“

    • Description=Diastolic Blood Pressure (Orig U)

    • def:OriginType="CRF“

    • def:PDFPageRefPageRefs="11“

    • ...


Thank you

Thank You !


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