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

2. CDISC Define-XML Specification Version 2.0 | Presentation Title | Presenter Name | Date | Subject | Business Use Only2 Value Level Metadata sections

3. what is the context? | Presentation Title | Presenter Name | Date | Subject | Business Use Only3 converting vertical files to horizontal USUBJIDVSTESTCDVSORRESVSORRESU 1HEIGHT78inches 1DIABP80mmHg 1FRMSIZEMEDIUM USUBJIDHEIGHTHEIGHTUDIABPDIABPUFRMSIZE 178inches80mmHgMEDIUM vertical file horizontal file

4. where does it live in define.xml? | Presentation Title | Presenter Name | Date | Subject | Business Use Only4 page 12

5. Codelists for VSTEST and VSTESTCD | Presentation Title | Presenter Name | Date | Subject | Business Use Only5 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.

6. define version 1 vs version 2 | Presentation Title | Presenter Name | Date | Subject | Business Use Only6 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

7. How the sections are chained together | Presentation Title | Presenter Name | Date | Subject | Business Use Only7 pages 35 - 40  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”

8. How the sections are chained together (cont...) | Presentation Title | Presenter Name | Date | Subject | Business Use Only8 pages 35 - 40  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“...

9. 9 Thank You !