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<!-- Value Level Metadata -->
<ValueListDef OID="VL.VS.VSORRES">
<ItemRef ItemOID="IT.VS.VSORRES.DIABP" OrderNumber="1" Mandatory="Yes">
<Origin Type="Collected" Source="Investigator">
<DocumentRef leafID="LF.acrf">
<PDFPageRef PageRefs="11" Type="PhysicalRef"/>
</DocumentRef>
</Origin>
<WhereClauseRef WhereClauseOID="WC.VS.VSTESTCD.DIABP"/>
</ItemRef>
<ItemRef ItemOID="IT.VS.VSORRES.FRMSIZE" OrderNumber="2" Mandatory="No">
<WhereClauseRef WhereClauseOID="WC.VS.VSTESTCD.FRMSIZE"/>
</ItemRef>
<ItemRef ItemOID="IT.VS.VSORRES.HEIGHT" OrderNumber="3" Mandatory="Yes">
<WhereClauseRef WhereClauseOID="WC.VS.VSTESTCD.HEIGHT"/>
</ItemRef>
<ItemRef ItemOID="IT.VS.VSORRES.PULSE" OrderNumber="4" Mandatory="No">
<WhereClauseRef WhereClauseOID="WC.VS.VSTESTCD.PULSE"/>
</ItemRef>
<ItemRef ItemOID="IT.VS.VSORRES.SYSBP" OrderNumber="5" Mandatory="Yes">
<WhereClauseRef WhereClauseOID="WC.VS.VSTESTCD.SYSBP"/>
</ItemRef>
<ItemRef ItemOID="IT.VS.VSORRES.WEIGHT" OrderNumber="6" Mandatory="Yes">
<WhereClauseRef WhereClauseOID="WC.VS.VSTESTCD.WEIGHT"/>
</ItemRef>
</ValueListDef>
<ValueListDef OID="VL.VS.VSSTRESC">
<ItemRef ItemOID="IT.VS.VSSTRESC.DIABP" OrderNumber="1" Mandatory="Yes">
<WhereClauseRef WhereClauseOID="WC.VS.VSTESTCD.DIABP"/>
</ItemRef>
<ItemRef ItemOID="IT.VS.VSSTRESC.FRMSIZE" OrderNumber="2" Mandatory="No">
<Origin Type="Collected" Source="Investigator">
<DocumentRef leafID="LF.acrf">
<PDFPageRef PageRefs="11" Type="PhysicalRef"/>
</DocumentRef>
</Origin>
<WhereClauseRef WhereClauseOID="WC.VS.VSTESTCD.FRMSIZE"/>
</ItemRef>
<ItemRef ItemOID="IT.VS.VSSTRESC.HEIGHT" OrderNumber="3" Mandatory="Yes">
<WhereClauseRef WhereClauseOID="WC.VS.VSTESTCD.BMI"/>
</ItemRef>
</ValueListDef>
<ValueListDef OID="VL.VS.VSSTRESN">
<ItemRef ItemOID="IT.VS.VSSTRESN.DIABP" OrderNumber="1" Mandatory="Yes">
<WhereClauseRef WhereClauseOID="WC.VS.VSTESTCD.DIABP"/>
</ItemRef>
<ItemRef ItemOID="IT.VS.VSSTRESN.HEIGHT" OrderNumber="3" Mandatory="Yes">
<WhereClauseRef WhereClauseOID="WC.VS.VSTESTCD.HEIGHT"/>
</ItemRef>
<ItemRef ItemOID="IT.VS.VSSTRESN.BMI" OrderNumber="7" Mandatory="Yes"
MethodOID="MT.BMISN">
<Origin Type="Derived" Source="Sponsor">
<Description>
<TranslatedText xml:lang="en" type="text/plain">EDC
System</TranslatedText>
</Description>
<DocumentRef leafID="LF.acrf">
<PDFPageRef PageRefs="11" Type="PhysicalRef"/>
</DocumentRef>
</Origin>
<WhereClauseRef WhereClauseOID="WC.VS.VSTESTCD.BMI"/>
</ItemRef>
</ValueListDef>
<!-- Dataset Definition (VS) -->
<ItemGroupDef OID="IG.VS" Domain="VS" Name="VS" Repeating="Simple" IsReferenceData="No"
Structure="One record per vital sign measurement per visit per subject"
Purpose="Tabulation" ArchiveLocationID="LF.VS">
<Description>
<TranslatedText xml:lang="en" type="text/plain">Vital Signs</TranslatedText>
</Description>
<ItemRef ItemOID="IT.STUDYID" Mandatory="Yes" OrderNumber="1" KeySequence="1"/>
<ItemRef ItemOID="IT.VS.DOMAIN" Mandatory="Yes" OrderNumber="2"/>
<ItemRef ItemOID="IT.USUBJID" Mandatory="Yes" OrderNumber="3" KeySequence="2"
MethodOID="MT.USUBJID"/>
<ItemRef ItemOID="IT.VS.VSORRES" Mandatory="No" OrderNumber="8">
<Origin Type="Collected" Source="Investigator">
<DocumentRef leafID="LF.acrf">
<PDFPageRef PageRefs="11" Type="PhysicalRef"/>
</DocumentRef>
</Origin>
</ItemRef>
<ItemRef ItemOID="IT.VS.VSORRESU" Mandatory="No" OrderNumber="9">
<Origin Type="Collected" Source="Investigator">
<DocumentRef leafID="LF.acrf">
<PDFPageRef PageRefs="11" Type="PhysicalRef"/>
</DocumentRef>
</Origin>
</ItemRef>
<ItemRef ItemOID="IT.VS.VSSTRESC" Mandatory="Yes" OrderNumber="10"
MethodOID="MT.VSSTRESC"/>
<ItemRef ItemOID="IT.VS.VSSTRESN" Mandatory="No" OrderNumber="11"
MethodOID="MT.VSSTRESN"/>
<ItemRef ItemOID="IT.VS.VSSTRESU" Mandatory="No" OrderNumber="12"/>
<Alias Context="SDTM-Class" Name="FINDINGS"/>
<Alias Context="Submission-SASDatasetName" Name="VS"/>
<leaf ID="LF.VS" xlink:href="vs.xpt">
<title>vs.xpt</title>
</leaf>
</ItemGroupDef>
<ItemDef OID="IT.VS.VSORRES" Name="VSORRES" DataType="text" Length="30">
<Description>
<TranslatedText xml:lang="en" type="text/plain">Result or Finding in Original
Units</TranslatedText>
</Description>
<ValueListRef ValueListOID="VL.VS.VSORRES"/>
<Alias Context="Submission-SASFieldName" Name="VSORRES"/>
</ItemDef>
<ItemDef OID="IT.VS.VSORRESU" Name="VSORRESU" DataType="text" Length="20">
<Description>
<TranslatedText xml:lang="en" type="text/plain">Original Units</TranslatedText>
</Description>
<ValueListRef ValueListOID="VL.VS.VSORRESU"/>
<Alias Context="Submission-SASFieldName" Name="VSORRESU"/>
</ItemDef>
<ItemDef OID="IT.VS.VSORRES.DIABP" Name="VSORRES1" DataType="integer" Length="2">
<Description>
<TranslatedText xml:lang="en" type="text/plain">Diastolic Blood Pressure in Orig
U</TranslatedText>
</Description>
<Alias Context="Submission-SASFieldName" Name="DIABPOR"/>
</ItemDef>
<ItemDef OID="IT.VS.VSORRES.FRMSIZE" Name="VSORRES2" DataType="text" Length="6">
<Description>
<TranslatedText xml:lang="en" type="text/plain">Body Frame Size -
Orig</TranslatedText>
</Description>
<CodeListRef CodeListOID="CL.SIZE"/>
<Alias Context="Submission-SASFieldName" Name="FRMSZOR"/>
</ItemDef>
<ItemDef OID="IT.VS.VSSTRESN.BMI" Name="VSSTRESN6" DataType="float" Length="6"
DisplayFormat="6.2">
<Description>
<TranslatedText xml:lang="en" type="text/plain">BMI Num in Std
U</TranslatedText>
</Description>
<Alias Context="Submission-SASFieldName" Name="BMISN"/>
</ItemDef>
<MethodDef OID="MT.BMISC" Name="Algorithm to derive BMISC" Type="Computation">
<Description>
<TranslatedText xml:lang="en" type="text/plain">character value of
VSSTRESN</TranslatedText>
</Description>
<FormalExpression Context=">=SAS 9.0">
<Code>putc(bmi_numeric_value,best.)</Code>
</FormalExpression>
<FormalExpression Context="R">
<Code>toString(bmi_numeric_value, witdth=NULL)</Code>
</FormalExpression>
</MethodDef>
<MethodDef OID="MT.BMISN" Name="Algorithm to derive BMISN" Type="Computation">
<Description>
<TranslatedText xml:lang="en" type="text/plain">round((VSSTRESN for weight/
(VSSTRESN for height / 100)^2), .01). Note: height and weight at the closest
visit collected.</TranslatedText>
</Description>
<FormalExpression Context="SAS 9.0+">
<Code>%bmisn_versionx(weight=retrieved_weight_closest_visit,height=retrieved_height_closest_visit)</Code>
</FormalExpression>
<FormalExpression Context="SAS 9.0+">
<Code>%bmisn_versiony(weight=retrieved_weight_closest_visit,height=retrieved_height_closest_visit)</Code>
</FormalExpression>
</MethodDef>
<leaf ID="LF.acrf" xlink:href="acrf.pdf">
<title>Annotated CRF</title>
</leaf> |
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