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Sample XML Document

Sample CDISC ODM XML Document

This is an example of an XML document that conforms to CDISC ODM.

<?xml version="1.0" encoding="windows-1252" ?>
<!--
      Clinical Data Interchange Standards Consortium (CDISC)
      Operational Data Model (ODM) for clinical data interchange

      You can learn more about CDISC standards efforts at 
      http://www.cdisc.org/standards/index.html
  -->

<ODM xmlns="http://www.cdisc.org/ns/odm/v1.2"
     xmlns:ds="http://www.w3.org/2000/09/xmldsig#"
     xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
     xsi:schemaLocation="http://www.cdisc.org/ns/odm/v1.2 ODM1-2-0.xsd"

     ODMVersion="1.2"
     FileOID="000-00-0000"
     FileType="Snapshot"
     Description="Adverse events from the CTChicago file"

     AsOfDateTime="2009-03-31T14:01:41"
     CreationDateTime="2009-03-31T14:01:41">

   <Study OID="STUDY.StudyOID">

      <!--
            GlobalVariables is a REQUIRED section in ODM markup
        -->
      <GlobalVariables>
         <StudyName>CDISC Connect-A-Thon Test Study III</StudyName>
         <StudyDescription>This file contains test data from a previous CDISC Connect-A-Thon.</StudyDescription>
         <ProtocolName>CDISC-Protocol-00-000</ProtocolName>
      </GlobalVariables>

      <BasicDefinitions />

      <!--
            Internal ODM markup required metadata
        -->
      <MetaDataVersion OID="v1.1.0" Name="Version 1.1.0">
         <Protocol>
            <StudyEventRef StudyEventOID="SE.VISIT1" OrderNumber="1" Mandatory="Yes" />
         </Protocol>

         <StudyEventDef OID="SE.VISIT1" Name="Study Event Definition" Repeating="Yes" Type="Common">
            <FormRef FormOID="FORM.AE" OrderNumber="1" Mandatory="No" />
         </StudyEventDef>

         <FormDef OID="FORM.AE" Name="Form Definition" Repeating="Yes">
            <ItemGroupRef ItemGroupOID="IG.AE" Mandatory="No" />
         </FormDef>


         <!--
               Columns defined in the table
           -->
         <ItemGroupDef OID="IG.AE" Repeating="Yes"
                       SASDatasetName="AE"
                       Name="Adverse Events"
                       Domain="AE"
                       Comment="Some adverse events from this trial">
            <ItemRef ItemOID="ID.TAREA"    OrderNumber="1"  Mandatory="No" />
            <ItemRef ItemOID="ID.PNO"      OrderNumber="2"  Mandatory="No" />
            <ItemRef ItemOID="ID.SCTRY"    OrderNumber="3"  Mandatory="No" />
            <ItemRef ItemOID="ID.F_STATUS" OrderNumber="4"  Mandatory="No" />
            <ItemRef ItemOID="ID.LINE_NO"  OrderNumber="5"  Mandatory="No" />
            <ItemRef ItemOID="ID.AETERM"   OrderNumber="6"  Mandatory="No" />
            <ItemRef ItemOID="ID.AESTMON"  OrderNumber="7"  Mandatory="No" />
            <ItemRef ItemOID="ID.AESTDAY"  OrderNumber="8"  Mandatory="No" />
            <ItemRef ItemOID="ID.AESTYR"   OrderNumber="9"  Mandatory="No" />
            <ItemRef ItemOID="ID.AESTDT"   OrderNumber="10" Mandatory="No" />
            <ItemRef ItemOID="ID.AEENMON"  OrderNumber="11" Mandatory="No" />
            <ItemRef ItemOID="ID.AEENDAY"  OrderNumber="12" Mandatory="No" />
            <ItemRef ItemOID="ID.AEENYR"   OrderNumber="13" Mandatory="No" />
            <ItemRef ItemOID="ID.AEENDT"   OrderNumber="14" Mandatory="No" />
            <ItemRef ItemOID="ID.AESEV"    OrderNumber="15" Mandatory="No" />
            <ItemRef ItemOID="ID.AEREL"    OrderNumber="16" Mandatory="No" />
            <ItemRef ItemOID="ID.AEOUT"    OrderNumber="17" Mandatory="No" />
            <ItemRef ItemOID="ID.AEACTTRT" OrderNumber="18" Mandatory="No" />
            <ItemRef ItemOID="ID.AECONTRT" OrderNumber="19" Mandatory="No" />
         </ItemGroupDef>


         <!--
               Column attributes as defined in the table
           -->
         <ItemDef OID="ID.TAREA"    SASFieldName="TAREA"    Name="Therapeutic Area"                      DataType="text"    Length="4">
            <CodeListRef CodeListOID="CL.$TAREAF" />                                                                        
         </ItemDef>                                                                                                         
         <ItemDef OID="ID.PNO"      SASFieldName="PNO"      Name="Protocol Number"                       DataType="text"    Length="15" />
         <ItemDef OID="ID.SCTRY"    SASFieldName="SCTRY"    Name="Country"                               DataType="text"    Length="4">
            <CodeListRef CodeListOID="CL.$SCTRYF" />                                                                        
         </ItemDef>                                                                                                         
         <ItemDef OID="ID.F_STATUS" SASFieldName="F_STATUS" Name="Record status, 5 levels, internal use" DataType="text"    Length="1">
            <CodeListRef CodeListOID="CL.$F_STATU" />
         </ItemDef>
         <ItemDef OID="ID.LINE_NO"  SASFieldName="LINE_NO"  Name="Line Number"                           DataType="integer" Length="2" />
         <ItemDef OID="ID.AETERM"   SASFieldName="AETERM"   Name="Conmed Indication"                     DataType="text"    Length="100" />
         <ItemDef OID="ID.AESTMON"  SASFieldName="AESTMON"  Name="Start Month - Enter Two Digits 01-12"  DataType="integer" Length="2" />
         <ItemDef OID="ID.AESTDAY"  SASFieldName="AESTDAY"  Name="Start Day - Enter Two Digits 01-31"    DataType="integer" Length="2" />
         <ItemDef OID="ID.AESTYR"   SASFieldName="AESTYR"   Name="Start Year - Enter Four Digit Year"    DataType="integer" Length="4" />
         <ItemDef OID="ID.AESTDT"   SASFieldName="AESTDT"   Name="Derived Start Date"                    DataType="date" />
         <ItemDef OID="ID.AEENMON"  SASFieldName="AEENMON"  Name="Stop Month - Enter Two Digits 01-12"   DataType="integer" Length="2" />
         <ItemDef OID="ID.AEENDAY"  SASFieldName="AEENDAY"  Name="Stop Day - Enter Two Digits 01-31"     DataType="integer" Length="2" />
         <ItemDef OID="ID.AEENYR"   SASFieldName="AEENYR"   Name="Stop Year - Enter Four Digit Year"     DataType="integer" Length="4" />
         <ItemDef OID="ID.AEENDT"   SASFieldName="AEENDT"   Name="Derived Stop Date"                     DataType="date" />
         <ItemDef OID="ID.AESEV"    SASFieldName="AESEV"    Name="Severity"                              DataType="text"    Length="1">
            <CodeListRef CodeListOID="CL.$AESEV" />
         </ItemDef>
         <ItemDef OID="ID.AEREL"    SASFieldName="AEREL"    Name="Relationship to study drug"            DataType="text"    Length="1">
            <CodeListRef CodeListOID="CL.$AEREL" />                                                                   
         </ItemDef>                                                                                                   
         <ItemDef OID="ID.AEOUT"    SASFieldName="AEOUT"    Name="Outcome"                               DataType="text"    Length="1">
            <CodeListRef CodeListOID="CL.$AEOUT" />                                                                      
         </ItemDef>                                                                                                         
         <ItemDef OID="ID.AEACTTRT" SASFieldName="AEACTTRT" Name="Actions taken re study drug"           DataType="text"    Length="1">
            <CodeListRef CodeListOID="CL.$AEACTTR" />                                                                       
         </ItemDef>                                                                                                         
         <ItemDef OID="ID.AECONTRT" SASFieldName="AECONTRT" Name="Actions taken, other"                  DataType="text"    Length="1">
            <CodeListRef CodeListOID="CL.$AECONTR" />
         </ItemDef>


         <!--
               Translation to ODM markup for any PROC FORMAT style
               user defined or SAS internal formatting specifications
               applied to columns in the table
           -->
         <CodeList OID="CL.$TAREAF" SASFormatName="$TAREAF" Name="$TAREAF" DataType="text">
            <CodeListItem CodedValue='ONC'>
               <Decode>
                  <TranslatedText xml:lang="en">Oncology</TranslatedText>
               </Decode>
            </CodeListItem>
         </CodeList>

         <CodeList OID="CL.$SCTRYF" SASFormatName="$SCTRYF" Name="$SCTRYF" DataType="text">
            <CodeListItem CodedValue='USA'>
               <Decode>
                  <TranslatedText xml:lang="en">United States</TranslatedText>
               </Decode>
            </CodeListItem>
         </CodeList>

         <CodeList OID="CL.$F_STATU" SASFormatName="$F_STATU" Name="$F_STATU" DataType="text">
            <CodeListItem CodedValue='S'>
               <Decode>
                  <TranslatedText xml:lang="en">Source verified, not queried</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue='V'>
               <Decode>
                  <TranslatedText xml:lang="en">Source verified, queried</TranslatedText>
               </Decode>
            </CodeListItem>
         </CodeList>

         <CodeList OID="CL.$AESEV" SASFormatName="$AESEV" Name="$AESEV" DataType="text">
            <CodeListItem CodedValue='1'>
               <Decode>
                  <TranslatedText xml:lang="en">Mild</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue='2'>
               <Decode>
                  <TranslatedText xml:lang="en">Moderate</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue='3'>
               <Decode>
                  <TranslatedText xml:lang="en">Severe</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue='4'>
               <Decode>
                  <TranslatedText xml:lang="en">Life Threatening</TranslatedText>
               </Decode>
            </CodeListItem>
         </CodeList>

         <CodeList OID="CL.$AEREL" SASFormatName="$AEREL" Name="$AEREL" DataType="text">
            <CodeListItem CodedValue='0'>
               <Decode>
                  <TranslatedText xml:lang="en">None</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue='1'>
               <Decode>
                  <TranslatedText xml:lang="en">Unlikely</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue='2'>
               <Decode>
                  <TranslatedText xml:lang="en">Possible</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue='3'>
               <Decode>
                  <TranslatedText xml:lang="en">Probable</TranslatedText>
               </Decode>
            </CodeListItem>
         </CodeList>

         <CodeList OID="CL.$AEOUT" SASFormatName="$AEOUT" Name="$AEOUT" DataType="text">
            <CodeListItem CodedValue='1'>
               <Decode>
                  <TranslatedText xml:lang="en">Resolved, no residual effects</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue='2'>
               <Decode>
                  <TranslatedText xml:lang="en">Continuing</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue='3'>
               <Decode>
                  <TranslatedText xml:lang="en">Resolved, residual effects</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue='4'>
               <Decode>
                  <TranslatedText xml:lang="en">Death</TranslatedText>
               </Decode>
            </CodeListItem>
         </CodeList>

         <CodeList OID="CL.$AEACTTR" SASFormatName="$AEACTTR" Name="$AEACTTR" DataType="text">
            <CodeListItem CodedValue='0'>
               <Decode>
                  <TranslatedText xml:lang="en">None</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue='1'>
               <Decode>
                  <TranslatedText xml:lang="en">Discontinued permanently</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue='2'>
               <Decode>
                  <TranslatedText xml:lang="en">Reduced</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue='3'>
               <Decode>
                  <TranslatedText xml:lang="en">Interrupted</TranslatedText>
               </Decode>
            </CodeListItem>
         </CodeList>

         <CodeList OID="CL.$AECONTR" SASFormatName="$AECONTR" Name="$AECONTR" DataType="text">
            <CodeListItem CodedValue='0'>
               <Decode>
                  <TranslatedText xml:lang="en">None</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue='1'>
               <Decode>
                  <TranslatedText xml:lang="en">Medication required</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue='2'>
               <Decode>
                  <TranslatedText xml:lang="en">Hospitalization required or prolonged</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue='3'>
               <Decode>
                  <TranslatedText xml:lang="en">Other</TranslatedText>
               </Decode>
            </CodeListItem>
         </CodeList>
      </MetaDataVersion>
   </Study>


   <!--
         Administrative metadata
     -->
   <AdminData />


   <!--
         Clinical Data   : AE
                           Adverse Events
                           Some adverse events from this trial
     -->
   <ClinicalData StudyOID="STUDY.StudyOID" MetaDataVersionOID="v1.1.0">
      <SubjectData SubjectKey="001">
         <StudyEventData StudyEventOID="SE.VISIT1" StudyEventRepeatKey="1">
            <FormData FormOID="FORM.AE" FormRepeatKey="1">
               <ItemGroupData ItemGroupOID="IG.AE" ItemGroupRepeatKey="1">
                  <ItemData ItemOID="ID.TAREA" Value="ONC" />
                  <ItemData ItemOID="ID.PNO" Value="143-02" />
                  <ItemData ItemOID="ID.SCTRY" Value="USA" />
                  <ItemData ItemOID="ID.F_STATUS" Value="V" />
                  <ItemData ItemOID="ID.LINE_NO" Value="1" />
                  <ItemData ItemOID="ID.AETERM" Value="HEADACHE" />
                  <ItemData ItemOID="ID.AESTMON" Value="06" />
                  <ItemData ItemOID="ID.AESTDAY" Value="10" />
                  <ItemData ItemOID="ID.AESTYR" Value="1999" />
                  <ItemData ItemOID="ID.AESTDT" Value="1999-06-10" />
                  <ItemData ItemOID="ID.AEENMON" Value="06" />
                  <ItemData ItemOID="ID.AEENDAY" Value="14" />
                  <ItemData ItemOID="ID.AEENYR" Value="1999" />
                  <ItemData ItemOID="ID.AEENDT" Value="1999-06-14" />
                  <ItemData ItemOID="ID.AESEV" Value="1" />
                  <ItemData ItemOID="ID.AEREL" Value="0" />
                  <ItemData ItemOID="ID.AEOUT" Value="1" />
                  <ItemData ItemOID="ID.AEACTTRT" Value="0" />
                  <ItemData ItemOID="ID.AECONTRT" Value="1" />
               </ItemGroupData>
               <ItemGroupData ItemGroupOID="IG.AE" ItemGroupRepeatKey="2">
                  <ItemData ItemOID="ID.TAREA" Value="ONC" />
                  <ItemData ItemOID="ID.PNO" Value="143-02" />
                  <ItemData ItemOID="ID.SCTRY" Value="USA" />
                  <ItemData ItemOID="ID.F_STATUS" Value="V" />
                  <ItemData ItemOID="ID.LINE_NO" Value="2" />
                  <ItemData ItemOID="ID.AETERM" Value="CONGESTION" />
                  <ItemData ItemOID="ID.AESTMON" Value="06" />
                  <ItemData ItemOID="ID.AESTDAY" Value="11" />
                  <ItemData ItemOID="ID.AESTYR" Value="1999" />
                  <ItemData ItemOID="ID.AESTDT" Value="1999-06-11" />
                  <ItemData ItemOID="ID.AEENMON" Value="" />
                  <ItemData ItemOID="ID.AEENDAY" Value="" />
                  <ItemData ItemOID="ID.AEENYR" Value="" />
                  <ItemData ItemOID="ID.AEENDT" Value="" />
                  <ItemData ItemOID="ID.AESEV" Value="1" />
                  <ItemData ItemOID="ID.AEREL" Value="0" />
                  <ItemData ItemOID="ID.AEOUT" Value="2" />
                  <ItemData ItemOID="ID.AEACTTRT" Value="0" />
                  <ItemData ItemOID="ID.AECONTRT" Value="1" />
               </ItemGroupData>
            </FormData>
         </StudyEventData>
      </SubjectData>
   </ClinicalData>
</ODM>

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