<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE ODM SYSTEM "odm1-1-0.dtd">
<ODM FileType="Snapshot" FileOID="987-654-321" CreationDateTime="2001-11-15T16:37:21-05:00">
   <Study OID="123-456-789">
      <GlobalVariables>
         <StudyName>CDISC Test Study II</StudyName>
         <StudyDescription>This file contains test data for the CDISC Connect-A-Thon event scheduled for the DIA 11th Annual European Workshop on Clinical Data Management.</StudyDescription>
         <ProtocolName>CDISC-123-456-789</ProtocolName>
      </GlobalVariables>
      <BasicDefinitions/>
      <MetaDataVersion OID="v1.01" Name="Version 1.01">
         <Protocol>
            <StudyEventRef StudyEventOID="SE.VISIT0" Mandatory="Yes"/>
            <StudyEventRef StudyEventOID="SE.VISIT1" Mandatory="Yes"/>
         </Protocol>
         <StudyEventDef OID="SE.VISIT0" Name="Pre-treatment" Repeating="No" Type="Scheduled">
            <FormRef FormOID="FORM.DEMOG" Mandatory="No"/>
            <FormRef FormOID="FORM.DRUGPHRM" Mandatory="No"/>
            <FormRef FormOID="FORM.PHARMVIT" Mandatory="No"/>
            <FormRef FormOID="FORM.VITPHYEX" Mandatory="No"/>
         </StudyEventDef>
         <StudyEventDef OID="SE.VISIT1" Name="Post-treatment" Repeating="No" Type="Scheduled">
            <FormRef FormOID="FORM.AE" Mandatory="No"/>
            <FormRef FormOID="FORM.CONMED" Mandatory="No"/>
            <FormRef FormOID="FORM.VITPHYEX" Mandatory="No"/>
         </StudyEventDef>
         <FormDef OID="FORM.AE" Name="Adverse Events" Repeating="No">
            <ItemGroupRef ItemGroupOID="IG.AE" Mandatory="No"/>
         </FormDef>
         <FormDef OID="FORM.CONMED" Name="Concom Meds" Repeating="No">
            <ItemGroupRef ItemGroupOID="IG.CONMED" Mandatory="No"/>
         </FormDef>
         <FormDef OID="FORM.DEMOG" Name="Demography" Repeating="No">
            <ItemGroupRef ItemGroupOID="IG.DEMOG" Mandatory="No"/>
         </FormDef>
         <FormDef OID="FORM.DRUGPHRM" Name="Treatment Assignment" Repeating="No">
            <ItemGroupRef ItemGroupOID="IG.DRUG_TRT" Mandatory="No"/>
         </FormDef>
         <FormDef OID="FORM.PHARMVIT" Name="Pharmacokinetics" Repeating="No">
            <ItemGroupRef ItemGroupOID="IG.PHARMO1" Mandatory="No"/>
         </FormDef>
         <FormDef OID="FORM.VITPHYEX" Name="Physical Exam" Repeating="No">
            <ItemGroupRef ItemGroupOID="IG.PHYEX" Mandatory="No"/>
         </FormDef>
         <ItemGroupDef OID="IG.AE" Name="Adverse Events" Repeating="Yes" IsReferenceData="No" SASDatasetName="AE">
            <ItemRef ItemOID="IT.REC_ID" Mandatory="No"/>
            <ItemRef ItemOID="IT.TAREA" Mandatory="No"/>
            <ItemRef ItemOID="IT.PNO" Mandatory="No"/>
            <ItemRef ItemOID="IT.SCTRY" Mandatory="No"/>
            <ItemRef ItemOID="IT.F_STATUS" Mandatory="No"/>
            <ItemRef ItemOID="IT.LINE_NO" Mandatory="No"/>
            <ItemRef ItemOID="IT.AETERM" Mandatory="No"/>
            <ItemRef ItemOID="IT.AESTMON" Mandatory="No"/>
            <ItemRef ItemOID="IT.AESTDAY" Mandatory="No"/>
            <ItemRef ItemOID="IT.AESTYR" Mandatory="No"/>
            <ItemRef ItemOID="IT.AESTDT" Mandatory="No"/>
            <ItemRef ItemOID="IT.AEENMON" Mandatory="No"/>
            <ItemRef ItemOID="IT.AEENDAY" Mandatory="No"/>
            <ItemRef ItemOID="IT.AEENYR" Mandatory="No"/>
            <ItemRef ItemOID="IT.AEENDT" Mandatory="No"/>
            <ItemRef ItemOID="IT.AESEV" Mandatory="No"/>
            <ItemRef ItemOID="IT.AEREL" Mandatory="No"/>
            <ItemRef ItemOID="IT.AEOUT" Mandatory="No"/>
            <ItemRef ItemOID="IT.AEACTTRT" Mandatory="No"/>
            <ItemRef ItemOID="IT.AECONTRT" Mandatory="No"/>
            <ItemRef ItemOID="IT.SITE" Mandatory="No"/>
         </ItemGroupDef>
         <ItemGroupDef OID="IG.CONMED" Name="Concom Meds" Repeating="Yes" IsReferenceData="No" SASDatasetName="CONMED">
            <ItemRef ItemOID="IT.REC_ID" Mandatory="No"/>
            <ItemRef ItemOID="IT.R_DRUG" Mandatory="No"/>
            <ItemRef ItemOID="IT.TAREA" Mandatory="No"/>
            <ItemRef ItemOID="IT.PNO" Mandatory="No"/>
            <ItemRef ItemOID="IT.SCTRY" Mandatory="No"/>
            <ItemRef ItemOID="IT.F_STATUS" Mandatory="No"/>
            <ItemRef ItemOID="IT.LINE_NO" Mandatory="No"/>
            <ItemRef ItemOID="IT.MEDIC" Mandatory="No"/>
            <ItemRef ItemOID="IT.STRTMON" Mandatory="No"/>
            <ItemRef ItemOID="IT.STRTDAY" Mandatory="No"/>
            <ItemRef ItemOID="IT.STRTYR" Mandatory="No"/>
            <ItemRef ItemOID="IT.STRT_DT" Mandatory="No"/>
            <ItemRef ItemOID="IT.ONGOING" Mandatory="No"/>
            <ItemRef ItemOID="IT.STOPMON" Mandatory="No"/>
            <ItemRef ItemOID="IT.STOPDAY" Mandatory="No"/>
            <ItemRef ItemOID="IT.STOPYR" Mandatory="No"/>
            <ItemRef ItemOID="IT.STOP_DT" Mandatory="No"/>
            <ItemRef ItemOID="IT.DOSEUNIT" Mandatory="No"/>
            <ItemRef ItemOID="IT.ROUTE" Mandatory="No"/>
            <ItemRef ItemOID="IT.REGIMEN" Mandatory="No"/>
            <ItemRef ItemOID="IT.INDIC" Mandatory="No"/>
            <ItemRef ItemOID="IT.AE_RELAT" Mandatory="No"/>
            <ItemRef ItemOID="IT.SITE" Mandatory="No"/>
         </ItemGroupDef>
         <ItemGroupDef OID="IG.DEMOG" Name="Demography" Repeating="Yes" IsReferenceData="No" SASDatasetName="DEMOG">
            <ItemRef ItemOID="IT.REC_ID" Mandatory="No"/>
            <ItemRef ItemOID="IT.R_DRUG" Mandatory="No"/>
            <ItemRef ItemOID="IT.TAREA" Mandatory="No"/>
            <ItemRef ItemOID="IT.PNO" Mandatory="No"/>
            <ItemRef ItemOID="IT.SCTRY" Mandatory="No"/>
            <ItemRef ItemOID="IT.F_STATUS" Mandatory="No"/>
            <ItemRef ItemOID="IT.HT" Mandatory="No"/>
            <ItemRef ItemOID="IT.WT" Mandatory="No"/>
            <ItemRef ItemOID="IT.SEX" Mandatory="No"/>
            <ItemRef ItemOID="IT.DOB" Mandatory="No"/>
            <ItemRef ItemOID="IT.RACE" Mandatory="No"/>
            <ItemRef ItemOID="IT.HTUNITS" Mandatory="No"/>
            <ItemRef ItemOID="IT.WTUNITS" Mandatory="No"/>
            <ItemRef ItemOID="IT.SITE" Mandatory="No"/>
         </ItemGroupDef>
         <ItemGroupDef OID="IG.DRUG_TRT" Name="Treatment Assignment" Repeating="Yes" IsReferenceData="No" SASDatasetName="DRUG_TRT">
            <ItemRef ItemOID="IT.REC_ID" Mandatory="No"/>
            <ItemRef ItemOID="IT.R_DRUG" Mandatory="No"/>
            <ItemRef ItemOID="IT.TAREA" Mandatory="No"/>
            <ItemRef ItemOID="IT.PNO" Mandatory="No"/>
            <ItemRef ItemOID="IT.SCTRY" Mandatory="No"/>
            <ItemRef ItemOID="IT.F_STATUS" Mandatory="No"/>
            <ItemRef ItemOID="IT.DRUG_TRT" Mandatory="No"/>
            <ItemRef ItemOID="IT.SITE" Mandatory="No"/>
         </ItemGroupDef>
         <ItemGroupDef OID="IG.PHARMO1" Name="Pharmacokinetics" Repeating="Yes" IsReferenceData="No" SASDatasetName="PHARMO1">
            <ItemRef ItemOID="IT.REC_ID" Mandatory="No"/>
            <ItemRef ItemOID="IT.R_DRUG" Mandatory="No"/>
            <ItemRef ItemOID="IT.TAREA" Mandatory="No"/>
            <ItemRef ItemOID="IT.PNO" Mandatory="No"/>
            <ItemRef ItemOID="IT.SCTRY" Mandatory="No"/>
            <ItemRef ItemOID="IT.F_STATUS" Mandatory="No"/>
            <ItemRef ItemOID="IT.PKYR0" Mandatory="No"/>
            <ItemRef ItemOID="IT.PKYR1" Mandatory="No"/>
            <ItemRef ItemOID="IT.PKYR2" Mandatory="No"/>
            <ItemRef ItemOID="IT.PKYR3" Mandatory="No"/>
            <ItemRef ItemOID="IT.PKYR4" Mandatory="No"/>
            <ItemRef ItemOID="IT.PKYR8" Mandatory="No"/>
            <ItemRef ItemOID="IT.PKYR16" Mandatory="No"/>
            <ItemRef ItemOID="IT.PKYR24" Mandatory="No"/>
            <ItemRef ItemOID="IT.MEALYR" Mandatory="No"/>
            <ItemRef ItemOID="IT.PKMON0" Mandatory="No"/>
            <ItemRef ItemOID="IT.PKMON1" Mandatory="No"/>
            <ItemRef ItemOID="IT.PKMON2" Mandatory="No"/>
            <ItemRef ItemOID="IT.PKMON3" Mandatory="No"/>
            <ItemRef ItemOID="IT.PKMON4" Mandatory="No"/>
            <ItemRef ItemOID="IT.PKMON8" Mandatory="No"/>
            <ItemRef ItemOID="IT.PKMON16" Mandatory="No"/>
            <ItemRef ItemOID="IT.PKMON24" Mandatory="No"/>
            <ItemRef ItemOID="IT.MEALMON" Mandatory="No"/>
            <ItemRef ItemOID="IT.PKDAY0" Mandatory="No"/>
            <ItemRef ItemOID="IT.PKDAY1" Mandatory="No"/>
            <ItemRef ItemOID="IT.PKDAY2" Mandatory="No"/>
            <ItemRef ItemOID="IT.PKDAY3" Mandatory="No"/>
            <ItemRef ItemOID="IT.PKDAY4" Mandatory="No"/>
            <ItemRef ItemOID="IT.PKDAY8" Mandatory="No"/>
            <ItemRef ItemOID="IT.PKDAY16" Mandatory="No"/>
            <ItemRef ItemOID="IT.PKDAY24" Mandatory="No"/>
            <ItemRef ItemOID="IT.MEALDAY" Mandatory="No"/>
            <ItemRef ItemOID="IT.NOTDONE" Mandatory="No"/>
            <ItemRef ItemOID="IT.PK_DT0" Mandatory="No"/>
            <ItemRef ItemOID="IT.PK_DT1" Mandatory="No"/>
            <ItemRef ItemOID="IT.PK_DT2" Mandatory="No"/>
            <ItemRef ItemOID="IT.PK_DT3" Mandatory="No"/>
            <ItemRef ItemOID="IT.PK_DT4" Mandatory="No"/>
            <ItemRef ItemOID="IT.PK_DT8" Mandatory="No"/>
            <ItemRef ItemOID="IT.PK_DT16" Mandatory="No"/>
            <ItemRef ItemOID="IT.PK_DT24" Mandatory="No"/>
            <ItemRef ItemOID="IT.MEAL_DT" Mandatory="No"/>
            <ItemRef ItemOID="IT.PK_TIM0" Mandatory="No"/>
            <ItemRef ItemOID="IT.PK_TIM1" Mandatory="No"/>
            <ItemRef ItemOID="IT.PK_TIM2" Mandatory="No"/>
            <ItemRef ItemOID="IT.PK_TIM3" Mandatory="No"/>
            <ItemRef ItemOID="IT.PK_TIM4" Mandatory="No"/>
            <ItemRef ItemOID="IT.PK_TIM8" Mandatory="No"/>
            <ItemRef ItemOID="IT.PK_TIM16" Mandatory="No"/>
            <ItemRef ItemOID="IT.PK_TIM24" Mandatory="No"/>
            <ItemRef ItemOID="IT.MEALTIM" Mandatory="No"/>
            <ItemRef ItemOID="IT.SITE" Mandatory="No"/>
         </ItemGroupDef>
         <ItemGroupDef OID="IG.PHYEX" Name="Physical Exam" Repeating="Yes" IsReferenceData="No" SASDatasetName="PHYEX">
            <ItemRef ItemOID="IT.REC_ID" Mandatory="No"/>
            <ItemRef ItemOID="IT.R_DRUG" Mandatory="No"/>
            <ItemRef ItemOID="IT.TAREA" Mandatory="No"/>
            <ItemRef ItemOID="IT.PNO" Mandatory="No"/>
            <ItemRef ItemOID="IT.SCTRY" Mandatory="No"/>
            <ItemRef ItemOID="IT.F_STATUS" Mandatory="No"/>
            <ItemRef ItemOID="IT.BODY_SYS" Mandatory="No"/>
            <ItemRef ItemOID="IT.ABNORM" Mandatory="No"/>
            <ItemRef ItemOID="IT.COMMT1" Mandatory="No"/>
            <ItemRef ItemOID="IT.SITE" Mandatory="No"/>
         </ItemGroupDef>
         <ItemDef OID="IT.ABNORM" Name="Normal/Abnormal/Not Done" DataType="integer" SASFieldName="ABNORM">
            <CodeListRef CodeListOID="CL.N_A_ND"/>
         </ItemDef>
         <ItemDef OID="IT.AEACTTRT" Name="Actions taken re study drug" DataType="text" Length="1" SASFieldName="AEACTTRT">
            <CodeListRef CodeListOID="CL.AEACTTR"/>
         </ItemDef>
         <ItemDef OID="IT.AECONTRT" Name="Actions taken, other" DataType="text" Length="1" SASFieldName="AECONTRT">
            <CodeListRef CodeListOID="CL.AECONTR"/>
         </ItemDef>
         <ItemDef OID="IT.AEENDAY" Name="Stop Day - Enter Two Digits 01-31" DataType="text" Length="2" SASFieldName="AEENDAY"/>
         <ItemDef OID="IT.AEENDT" Name="Derived Stop Date" DataType="text" Length="8" SASFieldName="AEENDT"/>
         <ItemDef OID="IT.AEENMON" Name="Stop Month - Enter Two Digits 01-12" DataType="text" Length="2" SASFieldName="AEENMON"/>
         <ItemDef OID="IT.AEENYR" Name="Stop Year - Enter Four Digit Year" DataType="text" Length="4" SASFieldName="AEENYR"/>
         <ItemDef OID="IT.AEOUT" Name="Outcome" DataType="text" Length="1" SASFieldName="AEOUT">
            <CodeListRef CodeListOID="CL.AEOUT"/>
         </ItemDef>
         <ItemDef OID="IT.AEREL" Name="Relationship to study drug" DataType="text" Length="1" SASFieldName="AEREL">
            <CodeListRef CodeListOID="CL.AEREL"/>
         </ItemDef>
         <ItemDef OID="IT.AESEV" Name="Severity" DataType="text" Length="1" SASFieldName="AESEV">
            <CodeListRef CodeListOID="CL.AESEV"/>
         </ItemDef>
         <ItemDef OID="IT.AESTDAY" Name="Start Day - Enter Two Digits 01-31" DataType="text" Length="2" SASFieldName="AESTDAY"/>
         <ItemDef OID="IT.AESTDT" Name="Derived Start Date" DataType="text" Length="8" SASFieldName="AESTDT"/>
         <ItemDef OID="IT.AESTMON" Name="Start Month - Enter Two Digits 01-12" DataType="text" Length="2" SASFieldName="AESTMON"/>
         <ItemDef OID="IT.AESTYR" Name="Start Year - Enter Four Digit Year" DataType="text" Length="4" SASFieldName="AESTYR"/>
         <ItemDef OID="IT.AETERM" Name="Conmed Indication" DataType="text" Length="100" SASFieldName="AETERM"/>
         <ItemDef OID="IT.AE_RELAT" Name="Check If Taken for AE" DataType="text" Length="1" SASFieldName="AE_RELAT">
            <CodeListRef CodeListOID="CL.AEREL"/>
         </ItemDef>
         <ItemDef OID="IT.BODY_SYS" Name="Physical Exam Body System" DataType="integer" SASFieldName="BODY_SYS">
            <CodeListRef CodeListOID="CL.PE_TEST"/>
         </ItemDef>
         <ItemDef OID="IT.COMMT1" Name="Comment" DataType="text" Length="200" SASFieldName="COMMT1"/>
         <ItemDef OID="IT.DOB" Name="Date of Birth" DataType="text" Length="8" SASFieldName="DOB"/>
         <ItemDef OID="IT.DOSEUNIT" Name="Dose and Unit" DataType="text" Length="20" SASFieldName="DOSEUNIT"/>
         <ItemDef OID="IT.DRUG_TRT" Name="Assigned Study Drug Treatment" DataType="integer" SASFieldName="DRUG_TRT">
            <CodeListRef CodeListOID="CL.DRUGTRTF"/>
         </ItemDef>
         <ItemDef OID="IT.F_STATUS" Name="Record status, 5 levels, internal use" DataType="text" Length="1" SASFieldName="F_STATUS">
            <CodeListRef CodeListOID="CL.F_STATU"/>
         </ItemDef>
         <ItemDef OID="IT.HT" Name="Height" DataType="float" SASFieldName="HT"/>
         <ItemDef OID="IT.HTUNITS" Name="Height Units" DataType="text" Length="2" SASFieldName="HTUNITS"/>
         <ItemDef OID="IT.INDIC" Name="Conmed Indication" DataType="text" Length="100" SASFieldName="INDIC"/>
         <ItemDef OID="IT.LINE_NO" Name="Line Number" DataType="float" SASFieldName="LINE_NO"/>
         <ItemDef OID="IT.MEALDAY" Name="Meal day" DataType="text" Length="2" SASFieldName="MEALDAY"/>
         <ItemDef OID="IT.MEALMON" Name="Meal mon" DataType="text" Length="2" SASFieldName="MEALMON"/>
         <ItemDef OID="IT.MEALTIM" Name="Time of last meal" DataType="text" Length="4" SASFieldName="MEALTIM"/>
         <ItemDef OID="IT.MEALYR" Name="Meal year" DataType="text" Length="4" SASFieldName="MEALYR"/>
         <ItemDef OID="IT.MEAL_DT" Name="Date of last meal" DataType="text" Length="8" SASFieldName="MEAL_DT"/>
         <ItemDef OID="IT.MEDIC" Name="Medication For Conmed" DataType="text" Length="200" SASFieldName="MEDIC"/>
         <ItemDef OID="IT.NOTDONE" Name="Not done" DataType="text" Length="1" SASFieldName="NOTDONE"/>
         <ItemDef OID="IT.ONGOING" Name="Check if Ongoing" DataType="text" Length="1" SASFieldName="ONGOING"/>
         <ItemDef OID="IT.PKDAY0" Name="Pretreatment day" DataType="text" Length="2" SASFieldName="PKDAY0"/>
         <ItemDef OID="IT.PKDAY1" Name="1-h day" DataType="text" Length="2" SASFieldName="PKDAY1"/>
         <ItemDef OID="IT.PKDAY16" Name="16-h day" DataType="text" Length="2" SASFieldName="PKDAY16"/>
         <ItemDef OID="IT.PKDAY2" Name="2-h day" DataType="text" Length="2" SASFieldName="PKDAY2"/>
         <ItemDef OID="IT.PKDAY24" Name="24-h day" DataType="text" Length="2" SASFieldName="PKDAY24"/>
         <ItemDef OID="IT.PKDAY3" Name="3-h day" DataType="text" Length="2" SASFieldName="PKDAY3"/>
         <ItemDef OID="IT.PKDAY4" Name="4-h day" DataType="text" Length="2" SASFieldName="PKDAY4"/>
         <ItemDef OID="IT.PKDAY8" Name="8-h day" DataType="text" Length="2" SASFieldName="PKDAY8"/>
         <ItemDef OID="IT.PKMON0" Name="Pretreatment mon" DataType="text" Length="2" SASFieldName="PKMON0"/>
         <ItemDef OID="IT.PKMON1" Name="1-h mon" DataType="text" Length="2" SASFieldName="PKMON1"/>
         <ItemDef OID="IT.PKMON16" Name="16-h mon" DataType="text" Length="2" SASFieldName="PKMON16"/>
         <ItemDef OID="IT.PKMON2" Name="2-h mon" DataType="text" Length="2" SASFieldName="PKMON2"/>
         <ItemDef OID="IT.PKMON24" Name="24-h mon" DataType="text" Length="2" SASFieldName="PKMON24"/>
         <ItemDef OID="IT.PKMON3" Name="3-h mon" DataType="text" Length="2" SASFieldName="PKMON3"/>
         <ItemDef OID="IT.PKMON4" Name="4-h mon" DataType="text" Length="2" SASFieldName="PKMON4"/>
         <ItemDef OID="IT.PKMON8" Name="8-h mon" DataType="text" Length="2" SASFieldName="PKMON8"/>
         <ItemDef OID="IT.PKYR0" Name="Pretreatment yr" DataType="text" Length="4" SASFieldName="PKYR0"/>
         <ItemDef OID="IT.PKYR1" Name="1-h year" DataType="text" Length="4" SASFieldName="PKYR1"/>
         <ItemDef OID="IT.PKYR16" Name="16-h year" DataType="text" Length="4" SASFieldName="PKYR16"/>
         <ItemDef OID="IT.PKYR2" Name="2-h year" DataType="text" Length="4" SASFieldName="PKYR2"/>
         <ItemDef OID="IT.PKYR24" Name="24-h year" DataType="text" Length="4" SASFieldName="PKYR24"/>
         <ItemDef OID="IT.PKYR3" Name="3-h year" DataType="text" Length="4" SASFieldName="PKYR3"/>
         <ItemDef OID="IT.PKYR4" Name="4-h year" DataType="text" Length="4" SASFieldName="PKYR4"/>
         <ItemDef OID="IT.PKYR8" Name="8-h year" DataType="text" Length="4" SASFieldName="PKYR8"/>
         <ItemDef OID="IT.PK_DT0" Name="Pretreatment date" DataType="text" Length="8" SASFieldName="PK_DT0"/>
         <ItemDef OID="IT.PK_DT1" Name="1-h date" DataType="text" Length="8" SASFieldName="PK_DT1"/>
         <ItemDef OID="IT.PK_DT16" Name="16-h date" DataType="text" Length="8" SASFieldName="PK_DT16"/>
         <ItemDef OID="IT.PK_DT2" Name="2-h date" DataType="text" Length="8" SASFieldName="PK_DT2"/>
         <ItemDef OID="IT.PK_DT24" Name="24-h date" DataType="text" Length="8" SASFieldName="PK_DT24"/>
         <ItemDef OID="IT.PK_DT3" Name="3-h date" DataType="text" Length="8" SASFieldName="PK_DT3"/>
         <ItemDef OID="IT.PK_DT4" Name="4-h date" DataType="text" Length="8" SASFieldName="PK_DT4"/>
         <ItemDef OID="IT.PK_DT8" Name="8-h date" DataType="text" Length="8" SASFieldName="PK_DT8"/>
         <ItemDef OID="IT.PK_TIM0" Name="Pretreatment time" DataType="text" Length="4" SASFieldName="PK_TIM0"/>
         <ItemDef OID="IT.PK_TIM1" Name="1-h time" DataType="text" Length="4" SASFieldName="PK_TIM1"/>
         <ItemDef OID="IT.PK_TIM16" Name="16-h time" DataType="text" Length="4" SASFieldName="PK_TIM16"/>
         <ItemDef OID="IT.PK_TIM2" Name="2-h time" DataType="text" Length="4" SASFieldName="PK_TIM2"/>
         <ItemDef OID="IT.PK_TIM24" Name="24-h time" DataType="text" Length="4" SASFieldName="PK_TIM24"/>
         <ItemDef OID="IT.PK_TIM3" Name="3-h time" DataType="text" Length="4" SASFieldName="PK_TIM3"/>
         <ItemDef OID="IT.PK_TIM4" Name="4-h time" DataType="text" Length="4" SASFieldName="PK_TIM4"/>
         <ItemDef OID="IT.PK_TIM8" Name="8-h time" DataType="text" Length="4" SASFieldName="PK_TIM8"/>
         <ItemDef OID="IT.PNO" Name="Protocol Number" DataType="text" Length="15" SASFieldName="PNO"/>
         <ItemDef OID="IT.RACE" Name="Ethnic Group" DataType="text" Length="10" SASFieldName="RACE"/>
         <ItemDef OID="IT.REC_ID" Name="Internal unique identifier for record" DataType="text" Length="40" SASFieldName="REC_ID"/>
         <ItemDef OID="IT.REGIMEN" Name="Conmed Regimen" DataType="integer" SASFieldName="REGIMEN">
            <CodeListRef CodeListOID="CL.REGF"/>
         </ItemDef>
         <ItemDef OID="IT.ROUTE" Name="Conmed Route" DataType="integer" SASFieldName="ROUTE">
            <CodeListRef CodeListOID="CL.ROUTEF"/>
         </ItemDef>
         <ItemDef OID="IT.R_DRUG" Name="Compound" DataType="text" Length="8" SASFieldName="R_DRUG"/>
         <ItemDef OID="IT.SCTRY" Name="Country" DataType="text" Length="4" SASFieldName="SCTRY">
            <CodeListRef CodeListOID="CL.SCTRYF"/>
         </ItemDef>
         <ItemDef OID="IT.SEX" Name="Gender" DataType="text" Length="6" SASFieldName="SEX">
            <CodeListRef CodeListOID="CL.SEXF"/>
         </ItemDef>
         <ItemDef OID="IT.SITE" Name="Investigational Site" DataType="text" Length="15" SASFieldName="SITE">
            <CodeListRef CodeListOID="CL.SITEF"/>
         </ItemDef>
         <ItemDef OID="IT.STOPDAY" Name="Stop Day - Enter Two Digits 01-31" DataType="text" Length="2" SASFieldName="STOPDAY"/>
         <ItemDef OID="IT.STOPMON" Name="Stop Month - Enter Two Digits 01-12" DataType="text" Length="2" SASFieldName="STOPMON"/>
         <ItemDef OID="IT.STOPYR" Name="Stop Year - Enter Four Digit Year" DataType="text" Length="4" SASFieldName="STOPYR"/>
         <ItemDef OID="IT.STOP_DT" Name="Derived Stop Date" DataType="text" Length="8" SASFieldName="STOP_DT"/>
         <ItemDef OID="IT.STRTDAY" Name="Start Day - Enter Two Digits 01-31" DataType="text" Length="2" SASFieldName="STRTDAY"/>
         <ItemDef OID="IT.STRTMON" Name="Start Month - Enter Two Digits 01-12" DataType="text" Length="2" SASFieldName="STRTMON"/>
         <ItemDef OID="IT.STRTYR" Name="Start Year - Enter Four Digit Year" DataType="text" Length="4" SASFieldName="STRTYR"/>
         <ItemDef OID="IT.STRT_DT" Name="Derived Start Date" DataType="text" Length="8" SASFieldName="STRT_DT"/>
         <ItemDef OID="IT.TAREA" Name="Therapeutic Area" DataType="text" Length="4" SASFieldName="TAREA">
            <CodeListRef CodeListOID="CL.TAREAF"/>
         </ItemDef>
         <ItemDef OID="IT.WT" Name="Weight" DataType="float" SASFieldName="WT"/>
         <ItemDef OID="IT.WTUNITS" Name="Weight Units" DataType="text" Length="2" SASFieldName="WTUNITS"/>
         <CodeList OID="CL.AEACTTR" Name="AE Action Taken, Study Drug" DataType="text" SASFormatName="AEACTTR">
            <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" Name="AE Action Taken, Other" DataType="text" SASFormatName="AECONTR">
            <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>
         <CodeList OID="CL.AEOUT" Name="AE Outcome" DataType="text" SASFormatName="AEOUT">
            <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.AEREL" Name="AE Relationship to Study Drug" DataType="text" SASFormatName="AEREL">
            <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.AESEV" Name="AE Severity" DataType="text" SASFormatName="AESEV">
            <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.DRUGTRTF" Name="Assigned Study Drug" DataType="integer" SASFormatName="DRUGTRTF">
            <CodeListItem CodedValue="1">
               <Decode>
                  <TranslatedText xml:lang="en">Treatment A</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="2">
               <Decode>
                  <TranslatedText xml:lang="en">Treatment B</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="3">
               <Decode>
                  <TranslatedText xml:lang="en">Treatment C</TranslatedText>
               </Decode>
            </CodeListItem>
         </CodeList>
         <CodeList OID="CL.F_STATU" Name="Record Status, Internal" DataType="text" SASFormatName="F_STATU">
            <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.N_A_ND" Name="Normal/Abnormal/Not Done" DataType="integer" SASFormatName="N_A_ND">
            <CodeListItem CodedValue="1">
               <Decode>
                  <TranslatedText xml:lang="en">Normal</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="2">
               <Decode>
                  <TranslatedText xml:lang="en">Abnormal</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="3">
               <Decode>
                  <TranslatedText xml:lang="en">Not Done</TranslatedText>
               </Decode>
            </CodeListItem>
         </CodeList>
         <CodeList OID="CL.PE_TEST" Name="PE Body System" DataType="integer" SASFormatName="PE_TEST">
            <CodeListItem CodedValue="1">
               <Decode>
                  <TranslatedText xml:lang="en">Head, Neck and Thyroid</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="2">
               <Decode>
                  <TranslatedText xml:lang="en">Eyes, Ears, Nose and Throat</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="3">
               <Decode>
                  <TranslatedText xml:lang="en">Chest</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="4">
               <Decode>
                  <TranslatedText xml:lang="en">Lungs</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="5">
               <Decode>
                  <TranslatedText xml:lang="en">Heart</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="6">
               <Decode>
                  <TranslatedText xml:lang="en">Lymph Nodes</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="7">
               <Decode>
                  <TranslatedText xml:lang="en">Abdomen</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="8">
               <Decode>
                  <TranslatedText xml:lang="en">Anorectal</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="9">
               <Decode>
                  <TranslatedText xml:lang="en">Genitalia</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="10">
               <Decode>
                  <TranslatedText xml:lang="en">Skin</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="11">
               <Decode>
                  <TranslatedText xml:lang="en">Musculoskeletal</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="12">
               <Decode>
                  <TranslatedText xml:lang="en">Neurological</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="13">
               <Decode>
                  <TranslatedText xml:lang="en">Other</TranslatedText>
               </Decode>
            </CodeListItem>
         </CodeList>
         <CodeList OID="CL.REGF" Name="Conmed Regimen" DataType="integer" SASFormatName="REGF">
            <CodeListItem CodedValue="1">
               <Decode>
                  <TranslatedText xml:lang="en">q.d.</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="2">
               <Decode>
                  <TranslatedText xml:lang="en">b.i.d.</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="3">
               <Decode>
                  <TranslatedText xml:lang="en">t.i.d.</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="4">
               <Decode>
                  <TranslatedText xml:lang="en">q.i.d.</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="5">
               <Decode>
                  <TranslatedText xml:lang="en">q.o.d.</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="6">
               <Decode>
                  <TranslatedText xml:lang="en">q.h.s.</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="7">
               <Decode>
                  <TranslatedText xml:lang="en">cont. IV</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="8">
               <Decode>
                  <TranslatedText xml:lang="en">prn</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="9">
               <Decode>
                  <TranslatedText xml:lang="en">If not in list, record as Other</TranslatedText>
               </Decode>
            </CodeListItem>
         </CodeList>
         <CodeList OID="CL.ROUTEF" Name="Conmed Route" DataType="integer" SASFormatName="ROUTEF">
            <CodeListItem CodedValue="1">
               <Decode>
                  <TranslatedText xml:lang="en">IV</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="2">
               <Decode>
                  <TranslatedText xml:lang="en">IM</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="3">
               <Decode>
                  <TranslatedText xml:lang="en">PO</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="4">
               <Decode>
                  <TranslatedText xml:lang="en">SC</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="5">
               <Decode>
                  <TranslatedText xml:lang="en">PV</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="6">
               <Decode>
                  <TranslatedText xml:lang="en">PR</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="7">
               <Decode>
                  <TranslatedText xml:lang="en">Sublingual</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="8">
               <Decode>
                  <TranslatedText xml:lang="en">Inhaled</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="9">
               <Decode>
                  <TranslatedText xml:lang="en">Topical</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="10">
               <Decode>
                  <TranslatedText xml:lang="en">If not in list</TranslatedText>
               </Decode>
            </CodeListItem>
         </CodeList>
         <CodeList OID="CL.SCTRYF" Name="Country" DataType="text" SASFormatName="SCTRYF">
            <CodeListItem CodedValue="USA">
               <Decode>
                  <TranslatedText xml:lang="en">United States</TranslatedText>
               </Decode>
            </CodeListItem>
         </CodeList>
         <CodeList OID="CL.SEXF" Name="Gender" DataType="text" SASFormatName="SEXF">
            <CodeListItem CodedValue="F">
               <Decode>
                  <TranslatedText xml:lang="en">Female</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="M">
               <Decode>
                  <TranslatedText xml:lang="en">Male</TranslatedText>
               </Decode>
            </CodeListItem>
         </CodeList>
         <CodeList OID="CL.SITEF" Name="Investigational Site" DataType="text" SASFormatName="SITEF">
            <CodeListItem CodedValue="FH">
               <Decode>
                  <TranslatedText xml:lang="en">Fred Hutchinson</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="RP">
               <Decode>
                  <TranslatedText xml:lang="en">Roswell Park</TranslatedText>
               </Decode>
            </CodeListItem>
         </CodeList>
         <CodeList OID="CL.TAREAF" Name="Therapeutic Area" DataType="text" SASFormatName="TAREAF">
            <CodeListItem CodedValue="ONC">
               <Decode>
                  <TranslatedText xml:lang="en">Oncology</TranslatedText>
               </Decode>
            </CodeListItem>
         </CodeList>
      </MetaDataVersion>
   </Study>
   <AdminData>
      <User OID="USR.cdisc001">
         <FullName>Shirley Williams</FullName>
         <FirstName>Shirley</FirstName>
         <LastName>Williams</LastName>
         <Organization>CDISC</Organization>
      </User>
      <Location OID="LOC.CDISCHome" Name="CDISC Headquarters" LocationType="Other">
         <MetaDataVersionRef StudyOID="123-456-789" MetaDataVersionOID="v1.01" EffectiveDate="20011019T10:45:57-05:00"/>
      </Location>
      <SignatureDef OID="SD.cdisc001-es" Methodology="Electronic">
         <Meaning>Signature Meaning</Meaning>
         <LegalReason>Legal Reason</LegalReason>
      </SignatureDef>
   </AdminData>
   <ClinicalData StudyOID="123-456-789" MetaDataVersionOID="v1.01">
      <SubjectData SubjectKey="001">
         <StudyEventData StudyEventOID="SE.VISIT0">
            <FormData FormOID="FORM.DEMOG">
               <Signature>
                  <UserRef UserOID="USR.cdisc001"/>
                  <LocationRef LocationOID="LOC.CDISCHome"/>
                  <SignatureRef SignatureOID="SD.cdisc001-es"/>
                  <DateTimeStamp>20010530T10:06:32</DateTimeStamp>
               </Signature>
               <ItemGroupData ItemGroupOID="IG.DEMOG" ItemGroupRepeatKey="1">
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                  <ItemData ItemOID="IT.R_DRUG" Value="SDP"/>
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                  <ItemData ItemOID="IT.HT" Value="73"/>
                  <ItemData ItemOID="IT.WT" Value="204"/>
                  <ItemData ItemOID="IT.SEX" Value="M"/>
                  <ItemData ItemOID="IT.DOB" Value="19600403"/>
                  <ItemData ItemOID="IT.RACE" Value="Caucasian"/>
                  <ItemData ItemOID="IT.HTUNITS" Value="in"/>
                  <ItemData ItemOID="IT.WTUNITS" Value="lb"/>
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               </ItemGroupData>
            </FormData>
            <FormData FormOID="FORM.DRUGPHRM">
               <Signature>
                  <UserRef UserOID="USR.cdisc001"/>
                  <LocationRef LocationOID="LOC.CDISCHome"/>
                  <SignatureRef SignatureOID="SD.cdisc001-es"/>
                  <DateTimeStamp>20010530T10:06:32</DateTimeStamp>
               </Signature>
               <ItemGroupData ItemGroupOID="IG.DRUG_TRT" ItemGroupRepeatKey="1">
                  <ItemData ItemOID="IT.REC_ID" Value="46878904"/>
                  <ItemData ItemOID="IT.R_DRUG" Value="SDP"/>
                  <ItemData ItemOID="IT.TAREA" Value="ONC"/>
                  <ItemData ItemOID="IT.PNO" Value="143-02"/>
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                  <ItemData ItemOID="IT.DRUG_TRT" Value="1"/>
                  <ItemData ItemOID="IT.SITE" Value="RP"/>
               </ItemGroupData>
            </FormData>
            <FormData FormOID="FORM.PHARMVIT">
               <Signature>
                  <UserRef UserOID="USR.cdisc001"/>
                  <LocationRef LocationOID="LOC.CDISCHome"/>
                  <SignatureRef SignatureOID="SD.cdisc001-es"/>
                  <DateTimeStamp>20010530T10:06:32</DateTimeStamp>
               </Signature>
               <ItemGroupData ItemGroupOID="IG.PHARMO1" ItemGroupRepeatKey="1">
                  <ItemData ItemOID="IT.REC_ID" Value="46881304"/>
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               <Signature>
                  <UserRef UserOID="USR.cdisc001"/>
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