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languagexml
firstline1
titleBMI MethodDef Example
linenumberstrue
            <!-- 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>