<?xml version="1.0" encoding="ISO-8859-1"?>
<!DOCTYPE ODM SYSTEM "odmv11-15-nx.dtd">
<!--
	This XML Example is intended to provide a very small, valid example of a CDISC study 
	using CDISC ODM V1.1
-->
<!--
	In this small example study, a pharmaceutical company is conducting a Phase II initial 
	efficacy study.  This pharmaceutical company ( "The Pharm" ) has hired a contract 
	research organization (CRO) to collect, clean and complete data for this study.  Pharm
	and the CRO use completely different clinical data management systems, so the 2 companies
	have agreed to use CDISC'S ODM V1.1 for their data exchange.

	The data are coming in slowly and only the CRF pages from the first two visits for two
	patients have been returned from the investigational site to the CRO so far.  During the
	first visit, both demographic and vital statistics data are collected. During the second
	visit, only  vital statistics are collected.  The data from the first patient's first visit
	included an incorrect systolic blood pressure. The incorrect value was changed to the
	correct value in a separate data entry session, and this change was captured in the audit
	trail of the clinical data management system. 
-->
<ODM FileType="Transactional" FileOID="987-654-321" CreationDateTime="2001-11-15T16:37:21-05:00" AsOfDateTime="2001-11-15T16:37:21-05:00" Description="Two visits for patients P001 and P027, plus updates of data for P001" Granularity="All">
   <Study OID="123-456-789">
      <GlobalVariables>
         <StudyName>HarrisonA</StudyName>
         <StudyDescription>Phase II initial efficacy</StudyDescription>
         <ProtocolName>B00-2136</ProtocolName>
      </GlobalVariables>
      <BasicDefinitions/>
      <!-- Beginning of metadata definitions . . .    -->
      <MetaDataVersion OID="MetaDataVersion.001" Name="Release 1">
         <Protocol>
            <!--There are 2 study events defined, corresponding to Visit 1 and Visit 2.  On "Demog and Vitials:, signing unit is used, while on Visit 2, the "Vitals Only" is used
 -->
            <StudyEventRef StudyEventOID="VISIT_1" Mandatory="Yes"/>
            <StudyEventRef StudyEventOID="VISIT_2" Mandatory="Yes"/>
         </Protocol>
         <StudyEventDef OID="VISIT_1" Name="Visit1" Repeating="No" Type="Scheduled">
            <FormRef FormOID="PAGE_1" Mandatory="No"/>
         </StudyEventDef>
         <StudyEventDef OID="VISIT_2" Name="Visit2" Repeating="No" Type="Scheduled">
            <FormRef FormOID="PAGE_2" Mandatory="No"/>
         </StudyEventDef>
         <!--There are 2 signing units defined: one to collect demograhics AND vitals and one to collect just vitals.
-->
         <FormDef OID="PAGE_1" Name="Demog and Vitals" Repeating="No">
            <ItemGroupRef ItemGroupOID="DEMOG" Mandatory="No"/>
            <ItemGroupRef ItemGroupOID="VITALS" Mandatory="No"/>
         </FormDef>
         <FormDef OID="PAGE_2" Name="Vitals Only" Repeating="No">
            <ItemGroupRef ItemGroupOID="VITALS" Mandatory="No"/>
         </FormDef>
         <!--There are 2 item groups (ItemGroups): Demographics and Vitals
-->
         <!--The demographics item group contains 7 item references (ItemRef) corresponding to Patient ID, Patient Initials, Sex, Date of Birth, Sponsor Patient ID, Weight (lb) and Weight (kg)-->
         <ItemGroupDef OID="DEMOG" Name="Demographics" Repeating="Yes" IsReferenceData="No" SASDatasetName="DEMOG">
            <ItemRef ItemOID="PT" Mandatory="No"/>
            <ItemRef ItemOID="INITIALS" Mandatory="No"/>
            <ItemRef ItemOID="SEX" Mandatory="No"/>
            <ItemRef ItemOID="DOB" Mandatory="No"/>
            <ItemRef ItemOID="SPONSOR_PTID" Mandatory="No"/>
            <ItemRef ItemOID="WEIGHT_LB" Mandatory="No"/>
            <ItemRef ItemOID="WEIGHT_KG" Mandatory="No"/>
         </ItemGroupDef>
         <!--The Vitals item group contains 6 item references (ItemRef) corresponding to the Patient ID, Visit Name, Systolic Blood Pressure, Diastolic Blood Pressure, Sponsor Patient ID, and Occurrence Number (of repeat measurement).-->
         <ItemGroupDef OID="VITALS" Name="Vital Signs" Repeating="Yes" IsReferenceData="No" SASDatasetName="VITALS">
            <ItemRef ItemOID="PT" Mandatory="No"/>
            <ItemRef ItemOID="VISITNAME" Mandatory="No"/>
            <ItemRef ItemOID="SBP" Mandatory="No"/>
            <ItemRef ItemOID="DBP" Mandatory="No"/>
            <ItemRef ItemOID="SPONSOR_PTID" Mandatory="No"/>
            <ItemRef ItemOID="OCCUR_NUM" Mandatory="No"/>
         </ItemGroupDef>
         <!--There are 12 items defined: Patient ID, Initials, Date of Birth, Sex, Systolic Blood Pressure, Diastolic Blood Pressure, Visit Name, Sponsor Patient ID, Visit Number (not currently used), Occurrence NUmber, Weight (lb) and Weight (kg).-->
         <ItemDef OID="PT" Name="PT" DataType="text" Length="4" SASFieldName="PT"/>
         <ItemDef OID="INITIALS" Name="Initials" DataType="text" Length="5" SASFieldName="INITIALS"/>
         <ItemDef OID="DOB" Name="Date of Birth" DataType="date" SASFieldName="DOB"/>
         <ItemDef Name="Sex" OID="SEX" DataType="text" Length="1" SASFieldName="SEX">
            <CodeListRef CodeListOID="CodeList.001"/>
         </ItemDef>
         <ItemDef OID="SBP" Name="Systolic Blood Pressure" DataType="integer" SASFieldName="SBP"/>
         <ItemDef OID="DBP" Name="Diastolic Blood Pressure" DataType="integer" SASFieldName="DBP"/>
         <ItemDef OID="VISITNAME" Name="Visit" DataType="text" Length="20" SASFieldName="VISNAME"/>
         <ItemDef OID="SPONSOR_PTID" Name="Sponsor Patient ID" DataType="text" Length="12" SASFieldName="SPONPTID"/>
         <ItemDef OID="VISITNUM" Name="Numeric Version fo Visit" DataType="integer" SASFieldName="VISITNUM"/>
         <ItemDef OID="OCCUR_NUM" Name="Occurence Number" DataType="integer" SASFieldName="OCCURNUM"/>
         <ItemDef OID="WEIGHT_LB" Name="Weight in pounds" DataType="float" SASFieldName="WEIGHTLB"/>
         <ItemDef OID="WEIGHT_KG" Name="Weight in kilograms " DataType="float" SASFieldName="WEIGHTKG"/>
         <!--There is a single codelist for Sex with entries for "m" and "f".-->
         <CodeList OID="CodeList.001" Name="Sex" DataType="text" SASFormatName="CL001">
            <CodeListItem CodedValue="m">
               <Decode>
                  <TranslatedText xml:lang="en">Male</TranslatedText>
               </Decode>
            </CodeListItem>
            <CodeListItem CodedValue="f">
               <Decode>
                  <TranslatedText xml:lang="en">Female</TranslatedText>
               </Decode>
            </CodeListItem>
         </CodeList>
         <!--Since structure and content of Presentation have not yet been defined, we have inserted an empty Presentation element.-->
         <Presentation OID=""/>
      </MetaDataVersion>
   </Study>
   <!--Beginning of Administrative Data-->
   <AdminData>
      <!--There are 2 users: John Doe (the investigator) and Mary Brown (the data entry person)-->
      <User OID="User.001">
         <FirstName>John</FirstName>
         <LastName>Doe</LastName>
      </User>
      <User OID="User.002">
         <FirstName>Mary</FirstName>
         <LastName>Brown</LastName>
      </User>
      <!--There is 1 location: General Hospital (a site).-->
      <Location OID="Location.001" Name="General Hospital" LocationType="Site">
         <MetaDataVersionRef StudyOID="123-456-789" MetaDataVersionOID="MetaDataVersion.001" EffectiveDate="2001-10-19T10:45:57-05:00"/>
      </Location>
      <!--There is one signature definition (electronic signature for data entry)
-->
      <SignatureDef OID="SignatureDef.001" Methodology="Electronic">
         <Meaning>Entry</Meaning>
         <LegalReason>Signer accepts responsibility for initial data entry</LegalReason>
      </SignatureDef>
   </AdminData>
   <!--Beginning of Clinical Data-->
   <ClinicalData StudyOID="123-456-789" MetaDataVersionOID="MetaDataVersion.001">
      <!-- SubjectData element for the first of 2 patients in this example  -->
      <SubjectData SubjectKey="P001" TransactionType="Insert">
         <!--  EventData element for Visit 1 for this patient  -->
         <StudyEventData StudyEventOID="VISIT_1">
            <!-- FormData element for the DEMOG and Vitals form collected on Visit 1 (Original)  -->
            <FormData FormOID="PAGE_1">
               <AuditRecord>
                  <UserRef UserOID="User.002"/>
                  <LocationRef LocationOID="Location.001"/>
                  <DateTimeStamp>2001-05-31-T10:08:40-05:00</DateTimeStamp>
               </AuditRecord>
               <!--  Electronic signature for this form   -->
               <Signature>
                  <UserRef UserOID="User.001"/>
                  <LocationRef LocationOID="Location.001"/>
                  <SignatureRef SignatureOID="SignatureDef.001"/>
                  <DateTimeStamp>2001-05-30T10:06:32-05:00</DateTimeStamp>
               </Signature>
               <!--  ItemGroupData element for the Demographics part of the form   -->
               <ItemGroupData ItemGroupOID="DEMOG" ItemGroupRepeatKey="1">
                  <ItemData ItemOID="PT" Value="P001"/>
                  <ItemData ItemOID="INITIALS" Value="AMH"/>
                  <ItemData ItemOID="SEX" Value="f"/>
                  <ItemData ItemOID="DOB" Value="1947-07-16"/>
                  <ItemData ItemOID="SPONSOR_PTID" Value="B00-2136-001"/>
                  <ItemData ItemOID="WEIGHT_LB" Value="150"/>
                  <ItemData ItemOID="WEIGHT_KG" Value="68.18"/>
                  <!--  ItemGroupData element for the Vitals part of the form     -->
               </ItemGroupData>
               <ItemGroupData ItemGroupOID="VITALS" ItemGroupRepeatKey="">
                  <ItemData ItemOID="PT" Value="P001"/>
                  <ItemData ItemOID="VISITNAME" Value="Visit1"/>
                  <ItemData ItemOID="SBP" Value="120"/>
                  <ItemData ItemOID="DBP" Value="80"/>
                  <ItemData ItemOID="SPONSOR_PTID" Value="B00-2136-001"/>
                  <ItemData ItemOID="OCCUR_NUM" Value="1"/>
               </ItemGroupData>
            </FormData>
            <!--  FormData element for the Vitals form collected on Visit 1 (Modified)    -->
         </StudyEventData>
         <!-- StudyEventData element for Visit 2 for the patient  -->
         <StudyEventData StudyEventOID="VISIT_2">
            <!--  FormData element for the Vitals only form collected on Visit 2  -->
            <FormData FormOID="PAGE_2">
               <AuditRecord>
                  <UserRef UserOID="User.002"/>
                  <LocationRef LocationOID="Location.001"/>
                  <DateTimeStamp>2001-05-31T9:06:45-05:00</DateTimeStamp>
               </AuditRecord>
               <!-- Electronic signature for this form -->
               <Signature>
                  <UserRef UserOID="User.001"/>
                  <LocationRef LocationOID="Location.001"/>
                  <SignatureRef SignatureOID="SignatureDef.001"/>
                  <DateTimeStamp>2001-05-30T10:06:32-05:00</DateTimeStamp>
               </Signature>
               <!--  Data for 3 repeats of Vitals item group on this form -->
               <ItemGroupData ItemGroupOID="VITALS" ItemGroupRepeatKey="1">
                  <ItemData ItemOID="PT" Value="P001"/>
                  <ItemData ItemOID="VISITNAME" Value="Visit2"/>
                  <ItemData ItemOID="SBP" Value="130"/>
                  <ItemData ItemOID="DBP" Value="90"/>
                  <ItemData ItemOID="SPONSOR_PTID" Value="B00-2136-001"/>
                  <ItemData ItemOID="OCCUR_NUM" Value="1"/>
               </ItemGroupData>
               <ItemGroupData ItemGroupOID="VITALS" ItemGroupRepeatKey="2">
                  <ItemData ItemOID="PT" Value="P001"/>
                  <ItemData ItemOID="VISITNAME" Value="Visit2"/>
                  <ItemData ItemOID="SBP" Value="125"/>
                  <ItemData ItemOID="DBP" Value="86"/>
                  <ItemData ItemOID="SPONSOR_PTID" Value="B00-2136-001"/>
                  <ItemData ItemOID="OCCUR_NUM" Value="2"/>
               </ItemGroupData>
               <ItemGroupData ItemGroupOID="VITALS" ItemGroupRepeatKey="3">
                  <ItemData ItemOID="PT" Value="P001"/>
                  <ItemData ItemOID="VISITNAME" Value="Visit2"/>
                  <ItemData ItemOID="SBP" Value="122"/>
                  <ItemData ItemOID="DBP" Value="84"/>
                  <ItemData ItemOID="SPONSOR_PTID" Value="B00-2136-001"/>
                  <ItemData ItemOID="OCCUR_NUM" Value="3"/>
               </ItemGroupData>
            </FormData>
         </StudyEventData>
      </SubjectData>
      <SubjectData SubjectKey="P001" TransactionType="Update">
         <StudyEventData StudyEventOID="VISIT_1">
            <FormData FormOID="PAGE_1">
               <AuditRecord>
                  <UserRef UserOID="User.002"/>
                  <LocationRef LocationOID="Location.001"/>
                  <DateTimeStamp>2001-05-31T08:47:07-05:00</DateTimeStamp>
                  <ReasonForChange>Error in initial data entry</ReasonForChange>
               </AuditRecord>
               <Signature>
                  <UserRef UserOID="User.001"/>
                  <LocationRef LocationOID="Location.001"/>
                  <SignatureRef SignatureOID="SignatureDef.001"/>
                  <DateTimeStamp>2001-05-30T10:06:32-05:00</DateTimeStamp>
               </Signature>
               <ItemGroupData ItemGroupOID="VITALS" ItemGroupRepeatKey="1">
                  <ItemData ItemOID="SBP" Value="130"/>
               </ItemGroupData>
            </FormData>
         </StudyEventData>
      </SubjectData>
      <SubjectData SubjectKey="P027" TransactionType="Insert">
         <!--  EventData element for Visit 1 for this patient  -->
         <StudyEventData StudyEventOID="VISIT_1">
            <!-- FormData element for the DEMOG and Vitals form collected on Visit 1 (Original)  -->
            <FormData FormOID="PAGE_1">
               <AuditRecord>
                  <UserRef UserOID="User.002"/>
                  <LocationRef LocationOID="Location.001"/>
                  <DateTimeStamp>2001-05-31-T10:08:40-05:00</DateTimeStamp>
               </AuditRecord>
               <!--  Electronic signature for this form   -->
               <Signature>
                  <UserRef UserOID="User.001"/>
                  <LocationRef LocationOID="Location.001"/>
                  <SignatureRef SignatureOID="SignatureDef.001"/>
                  <DateTimeStamp>2001-05-30T10:06:32-05:00</DateTimeStamp>
               </Signature>
               <!--  ItemGroupData element for the Demographics part of the form   -->
               <ItemGroupData ItemGroupOID="DEMOG" ItemGroupRepeatKey="1">
                  <ItemData ItemOID="PT" Value="P027"/>
                  <ItemData ItemOID="INITIALS" Value="VLP"/>
                  <ItemData ItemOID="SEX" Value="f"/>
                  <ItemData ItemOID="DOB" Value="1944-12-20"/>
                  <ItemData ItemOID="SPONSOR_PTID" Value="B00-2136-027"/>
                  <ItemData ItemOID="WEIGHT_LB" Value="139"/>
                  <ItemData ItemOID="WEIGHT_KG" Value="63.04"/>
                  <!--  ItemGroupData element for the Vitals part of the form     -->
               </ItemGroupData>
               <ItemGroupData ItemGroupOID="VITALS" ItemGroupRepeatKey="">
                  <ItemData ItemOID="PT" Value="P027"/>
                  <ItemData ItemOID="VISITNAME" Value="Visit1"/>
                  <ItemData ItemOID="SBP" Value="115"/>
                  <ItemData ItemOID="DBP" Value="75"/>
                  <ItemData ItemOID="SPONSOR_PTID" Value="B00-2136-027"/>
                  <ItemData ItemOID="OCCUR_NUM" Value="1"/>
               </ItemGroupData>
            </FormData>
            <!--  FormData element for the Vitals form collected on Visit 1 (Modified)    -->
         </StudyEventData>
         <!-- StudyEventData element for Visit 2 for the patient  -->
         <StudyEventData StudyEventOID="VISIT_2">
            <!--  FormData element for the Vitals only form collected on Visit 2  -->
            <FormData FormOID="PAGE_2">
               <AuditRecord>
                  <UserRef UserOID="User.002"/>
                  <LocationRef LocationOID="Location.001"/>
                  <DateTimeStamp>2001-05-31T9:06:45-05:00</DateTimeStamp>
               </AuditRecord>
               <!-- Electronic signature for this form -->
               <Signature>
                  <UserRef UserOID="User.001"/>
                  <LocationRef LocationOID="Location.001"/>
                  <SignatureRef SignatureOID="SignatureDef.001"/>
                  <DateTimeStamp>2001-05-30T10:06:32-05:00</DateTimeStamp>
               </Signature>
               <!--  Data for 3 repeats of Vitals item group on this form -->
               <ItemGroupData ItemGroupOID="VITALS" ItemGroupRepeatKey="1">
                  <ItemData ItemOID="PT" Value="P027"/>
                  <ItemData ItemOID="VISITNAME" Value="Visit2"/>
                  <ItemData ItemOID="SBP" Value="120"/>
                  <ItemData ItemOID="DBP" Value="90"/>
                  <ItemData ItemOID="SPONSOR_PTID" Value="B00-2136-027"/>
                  <ItemData ItemOID="OCCUR_NUM" Value="1"/>
               </ItemGroupData>
               <ItemGroupData ItemGroupOID="VITALS" ItemGroupRepeatKey="2">
                  <ItemData ItemOID="PT" Value="P027"/>
                  <ItemData ItemOID="VISITNAME" Value="Visit2"/>
                  <ItemData ItemOID="SBP" Value="120"/>
                  <ItemData ItemOID="DBP" Value="80"/>
                  <ItemData ItemOID="SPONSOR_PTID" Value="B00-2136-027"/>
                  <ItemData ItemOID="OCCUR_NUM" Value="2"/>
               </ItemGroupData>
               <ItemGroupData ItemGroupOID="VITALS" ItemGroupRepeatKey="3">
                  <ItemData ItemOID="PT" Value="P027"/>
                  <ItemData ItemOID="VISITNAME" Value="Visit2"/>
                  <ItemData ItemOID="SBP" Value="125"/>
                  <ItemData ItemOID="DBP" Value="80"/>
                  <ItemData ItemOID="SPONSOR_PTID" Value="B00-2136-027"/>
                  <ItemData ItemOID="OCCUR_NUM" Value="3"/>
               </ItemGroupData>
            </FormData>
         </StudyEventData>
      </SubjectData>
   </ClinicalData>
</ODM>

