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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" Type="Dataset" 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" typeType="text/plain">Vital Signs</TranslatedText> </Description> <Class Name="FINDINGS"/> <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="SAS" Name="VS"/> <leaf<Leaf ID="LF.VS" xlink:href="vs.xpt"> <title>vs<Title>vs.xpt</title>Title> </leaf>Leaf> </ItemGroupDef> <ItemDef OID="IT.VS.VSORRES" Name="VSORRES" DataType="text" Length="30"> <Description> <TranslatedText xml:lang="en" typeType="text/plain">Result or Finding in Original Units</TranslatedText> </Description> <ValueListRef ValueListOID="VL.VS.VSORRES"/> <Alias Context="SAS" Name="VSORRES"/> </ItemDef> <ItemDef OID="IT.VS.VSORRESU" Name="VSORRESU" DataType="text" Length="20"> <Description> <TranslatedText xml:lang="en" typeType="text/plain">Original Units</TranslatedText> </Description> <ValueListRef ValueListOID="VL.VS.VSORRESU"/> <Alias Context="SAS" Name="VSORRESU"/> </ItemDef> <ItemDef OID="IT.VS.VSORRES.DIABP" Name="VSORRES1" DataType="integer" Length="2"> <Description> <TranslatedText xml:lang="en" typeType="text/plain">Diastolic Blood Pressure in Orig U</TranslatedText> </Description> <Alias Context="SAS" Name="DIABPOR"/> </ItemDef> <ItemDef OID="IT.VS.VSORRES.FRMSIZE" Name="VSORRES2" DataType="text" Length="6"> <Description> <TranslatedText xml:lang="en" typeType="text/plain">Body Frame Size - Orig</TranslatedText> </Description> <CodeListRef CodeListOID="CL.SIZE"/> <Alias Context="SAS" Name="FRMSZOR"/> </ItemDef> <ItemDef OID="IT.VS.VSSTRESN.BMI" Name="VSSTRESN6" DataType="float" Length="6" DisplayFormat="6.2"> <Description> <TranslatedText xml:lang="en" typeType="text/plain">BMI Num in Std U</TranslatedText> </Description> <Alias Context="SAS" Name="BMISN"/> </ItemDef> <MethodDef OID="MT.BMISC" Name="Algorithm to derive BMISC" Type="Computation"> <Description> <TranslatedText xml:lang="en" typeType="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" typeType="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<Leaf ID="LF.acrf" xlink:href="acrf.pdf"> <title>Annotated<Title>Annotated CRF</title>Title> </leaf>Leaf> |
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