|
| 1 | +<?xml version="1.0" ?> |
| 2 | +<ODM xmlns="http://www.cdisc.org/ns/odm/v1.3" xmlns:def="http://www.cdisc.org/ns/def/v2.1" xmlns:rwdl="http://www.cdisc.org/ns/rwd-lineage/v1" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="http://www.cdisc.org/ns/odm/v1.3 https://www.cdisc.org/standards/odm/v1.3.2/ODM1-3-2.xsd" FileType="Snapshot" FileOID="Define.Example2" CreationDateTime="2026-03-19T00:00:00" AsOfDateTime="2026-03-19T00:00:00" Originator="CDISC RWD Lineage Project" SourceSystem="Example" SourceSystemVersion="1.0" def:Context="Submission"> |
| 3 | + <Study OID="Study.Example2"> |
| 4 | + <GlobalVariables> |
| 5 | + <StudyName>RWD Lineage Example 2</StudyName> |
| 6 | + <StudyDescription>Example 2: AE and LB domains with EHR lab source lineage</StudyDescription> |
| 7 | + <ProtocolName>RWDL-EX2</ProtocolName> |
| 8 | + </GlobalVariables> |
| 9 | + <MetaDataVersion OID="MDV.Example2" Name="Example 2 Define-XML" def:DefineVersion="2.1.0" def:StandardName="SDTM" def:StandardVersion="1.9"> |
| 10 | + <rwdl:lineage> |
| 11 | + <rwdl:ref leafID="LF.RWDLINEAGE">rwd-lineage.xml</rwdl:ref> |
| 12 | + </rwdl:lineage> |
| 13 | + <ItemGroupDef OID="IG.AE" Name="AE" Repeating="Yes" IsReferenceData="No" SASDatasetName="AE" def:Structure="One record per subject per adverse event" def:Purpose="Tabulation" def:StandardOID="STD.1" def:ArchiveLocationID="LF.AE"> |
| 14 | + <Description> |
| 15 | + <TranslatedText>Adverse Events</TranslatedText> |
| 16 | + </Description> |
| 17 | + <ItemRef ItemOID="IT.AE.STUDYID" Mandatory="Yes"/> |
| 18 | + <ItemRef ItemOID="IT.AE.DOMAIN" Mandatory="Yes"/> |
| 19 | + <ItemRef ItemOID="IT.AE.USUBJID" Mandatory="Yes"/> |
| 20 | + <ItemRef ItemOID="IT.AE.AESEQ" Mandatory="Yes"/> |
| 21 | + <ItemRef ItemOID="IT.AE.AETERM" Mandatory="Yes"/> |
| 22 | + <ItemRef ItemOID="IT.AE.AEDECOD" Mandatory="No"/> |
| 23 | + <ItemRef ItemOID="IT.AE.AELLTCD" Mandatory="No"/> |
| 24 | + <ItemRef ItemOID="IT.AE.AESER" Mandatory="No"/> |
| 25 | + <ItemRef ItemOID="IT.AE.AEREL" Mandatory="No"/> |
| 26 | + <ItemRef ItemOID="IT.AE.AESTDTC" Mandatory="No"/> |
| 27 | + </ItemGroupDef> |
| 28 | + <ItemGroupDef OID="IG.LB" Name="LB" Repeating="Yes" IsReferenceData="No" SASDatasetName="LB" def:Structure="One record per subject per lab test per visit" def:Purpose="Tabulation" def:StandardOID="STD.1" def:ArchiveLocationID="LF.LB"> |
| 29 | + <Description> |
| 30 | + <TranslatedText>Laboratory Test Results</TranslatedText> |
| 31 | + </Description> |
| 32 | + <ItemRef ItemOID="IT.LB.STUDYID" Mandatory="Yes"/> |
| 33 | + <ItemRef ItemOID="IT.LB.DOMAIN" Mandatory="Yes"/> |
| 34 | + <ItemRef ItemOID="IT.LB.USUBJID" Mandatory="Yes"/> |
| 35 | + <ItemRef ItemOID="IT.LB.LBSEQ" Mandatory="Yes"/> |
| 36 | + <ItemRef ItemOID="IT.LB.LBTESTCD" Mandatory="Yes"/> |
| 37 | + <ItemRef ItemOID="IT.LB.LBTEST" Mandatory="Yes"/> |
| 38 | + <ItemRef ItemOID="IT.LB.LBDTC" Mandatory="No"/> |
| 39 | + <ItemRef ItemOID="IT.LB.LBORRES" Mandatory="No"/> |
| 40 | + <ItemRef ItemOID="IT.LB.LBORRESU" Mandatory="No"/> |
| 41 | + <ItemRef ItemOID="IT.LB.LBSTRES" Mandatory="No"/> |
| 42 | + <ItemRef ItemOID="IT.LB.LBSTRESU" Mandatory="No"/> |
| 43 | + <ItemRef ItemOID="IT.LB.LBSTNRLO" Mandatory="No"/> |
| 44 | + <ItemRef ItemOID="IT.LB.LBSTNRHI" Mandatory="No"/> |
| 45 | + <ItemRef ItemOID="IT.LB.LBNRIND" Mandatory="No"/> |
| 46 | + </ItemGroupDef> |
| 47 | + <ItemDef OID="IT.AE.STUDYID" Name="STUDYID" DataType="text" Length="8" def:Label="Study Identifier"> |
| 48 | + <Description> |
| 49 | + <TranslatedText>Study Identifier</TranslatedText> |
| 50 | + </Description> |
| 51 | + </ItemDef> |
| 52 | + <ItemDef OID="IT.AE.DOMAIN" Name="DOMAIN" DataType="text" Length="2" def:Label="Domain Abbreviation"> |
| 53 | + <Description> |
| 54 | + <TranslatedText>Domain Abbreviation</TranslatedText> |
| 55 | + </Description> |
| 56 | + </ItemDef> |
| 57 | + <ItemDef OID="IT.AE.USUBJID" Name="USUBJID" DataType="text" Length="50" def:Label="Unique Subject Identifier"> |
| 58 | + <Description> |
| 59 | + <TranslatedText>Unique Subject Identifier</TranslatedText> |
| 60 | + </Description> |
| 61 | + </ItemDef> |
| 62 | + <ItemDef OID="IT.AE.AESEQ" Name="AESEQ" DataType="integer" Length="8" def:Label="Sequence Number"> |
| 63 | + <Description> |
| 64 | + <TranslatedText>Sequence Number</TranslatedText> |
| 65 | + </Description> |
| 66 | + </ItemDef> |
| 67 | + <ItemDef OID="IT.AE.AETERM" Name="AETERM" DataType="text" Length="200" def:Label="Reported Term for AE"> |
| 68 | + <Description> |
| 69 | + <TranslatedText>Reported Term for AE</TranslatedText> |
| 70 | + </Description> |
| 71 | + </ItemDef> |
| 72 | + <ItemDef OID="IT.AE.AEDECOD" Name="AEDECOD" DataType="text" Length="200" def:Label="Dictionary-Derived Term"> |
| 73 | + <Description> |
| 74 | + <TranslatedText>Dictionary-Derived Term</TranslatedText> |
| 75 | + </Description> |
| 76 | + </ItemDef> |
| 77 | + <ItemDef OID="IT.AE.AELLTCD" Name="AELLTCD" DataType="integer" Length="8" def:Label="Lowest Level Term Code"> |
| 78 | + <Description> |
| 79 | + <TranslatedText>Lowest Level Term Code</TranslatedText> |
| 80 | + </Description> |
| 81 | + </ItemDef> |
| 82 | + <ItemDef OID="IT.AE.AESER" Name="AESER" DataType="text" Length="1" def:Label="Serious Event"> |
| 83 | + <Description> |
| 84 | + <TranslatedText>Serious Event</TranslatedText> |
| 85 | + </Description> |
| 86 | + </ItemDef> |
| 87 | + <ItemDef OID="IT.AE.AEREL" Name="AEREL" DataType="text" Length="16" def:Label="Causality"> |
| 88 | + <Description> |
| 89 | + <TranslatedText>Causality</TranslatedText> |
| 90 | + </Description> |
| 91 | + </ItemDef> |
| 92 | + <ItemDef OID="IT.AE.AESTDTC" Name="AESTDTC" DataType="text" Length="20" def:Label="Start Date/Time"> |
| 93 | + <Description> |
| 94 | + <TranslatedText>Start Date/Time</TranslatedText> |
| 95 | + </Description> |
| 96 | + </ItemDef> |
| 97 | + <ItemDef OID="IT.LB.STUDYID" Name="STUDYID" DataType="text" Length="8" def:Label="Study Identifier"> |
| 98 | + <Description> |
| 99 | + <TranslatedText>Study Identifier</TranslatedText> |
| 100 | + </Description> |
| 101 | + </ItemDef> |
| 102 | + <ItemDef OID="IT.LB.DOMAIN" Name="DOMAIN" DataType="text" Length="2" def:Label="Domain Abbreviation"> |
| 103 | + <Description> |
| 104 | + <TranslatedText>Domain Abbreviation</TranslatedText> |
| 105 | + </Description> |
| 106 | + </ItemDef> |
| 107 | + <ItemDef OID="IT.LB.USUBJID" Name="USUBJID" DataType="text" Length="50" def:Label="Unique Subject Identifier"> |
| 108 | + <Description> |
| 109 | + <TranslatedText>Unique Subject Identifier</TranslatedText> |
| 110 | + </Description> |
| 111 | + </ItemDef> |
| 112 | + <ItemDef OID="IT.LB.LBSEQ" Name="LBSEQ" DataType="integer" Length="8" def:Label="Sequence Number"> |
| 113 | + <Description> |
| 114 | + <TranslatedText>Sequence Number</TranslatedText> |
| 115 | + </Description> |
| 116 | + </ItemDef> |
| 117 | + <ItemDef OID="IT.LB.LBTESTCD" Name="LBTESTCD" DataType="text" Length="8" def:Label="Lab Test Short Name"> |
| 118 | + <Description> |
| 119 | + <TranslatedText>Lab Test Short Name</TranslatedText> |
| 120 | + </Description> |
| 121 | + </ItemDef> |
| 122 | + <ItemDef OID="IT.LB.LBTEST" Name="LBTEST" DataType="text" Length="40" def:Label="Lab Test Name"> |
| 123 | + <Description> |
| 124 | + <TranslatedText>Lab Test Name</TranslatedText> |
| 125 | + </Description> |
| 126 | + </ItemDef> |
| 127 | + <ItemDef OID="IT.LB.LBDTC" Name="LBDTC" DataType="text" Length="20" def:Label="Date/Time of Specimen Collection"> |
| 128 | + <Description> |
| 129 | + <TranslatedText>Date/Time of Specimen Collection</TranslatedText> |
| 130 | + </Description> |
| 131 | + </ItemDef> |
| 132 | + <ItemDef OID="IT.LB.LBORRES" Name="LBORRES" DataType="text" Length="200" def:Label="Result or Finding in Original Units"> |
| 133 | + <Description> |
| 134 | + <TranslatedText>Result or Finding in Original Units</TranslatedText> |
| 135 | + </Description> |
| 136 | + </ItemDef> |
| 137 | + <ItemDef OID="IT.LB.LBORRESU" Name="LBORRESU" DataType="text" Length="40" def:Label="Original Units"> |
| 138 | + <Description> |
| 139 | + <TranslatedText>Original Units</TranslatedText> |
| 140 | + </Description> |
| 141 | + </ItemDef> |
| 142 | + <ItemDef OID="IT.LB.LBSTRES" Name="LBSTRES" DataType="float" Length="8" def:Label="Numeric Result/Finding in Standard Units"> |
| 143 | + <Description> |
| 144 | + <TranslatedText>Numeric Result/Finding in Standard Units</TranslatedText> |
| 145 | + </Description> |
| 146 | + </ItemDef> |
| 147 | + <ItemDef OID="IT.LB.LBSTRESU" Name="LBSTRESU" DataType="text" Length="40" def:Label="Standard Units"> |
| 148 | + <Description> |
| 149 | + <TranslatedText>Standard Units</TranslatedText> |
| 150 | + </Description> |
| 151 | + </ItemDef> |
| 152 | + <ItemDef OID="IT.LB.LBSTNRLO" Name="LBSTNRLO" DataType="float" Length="8" def:Label="Reference Range Lower Limit"> |
| 153 | + <Description> |
| 154 | + <TranslatedText>Reference Range Lower Limit</TranslatedText> |
| 155 | + </Description> |
| 156 | + </ItemDef> |
| 157 | + <ItemDef OID="IT.LB.LBSTNRHI" Name="LBSTNRHI" DataType="float" Length="8" def:Label="Reference Range Upper Limit"> |
| 158 | + <Description> |
| 159 | + <TranslatedText>Reference Range Upper Limit</TranslatedText> |
| 160 | + </Description> |
| 161 | + </ItemDef> |
| 162 | + <ItemDef OID="IT.LB.LBNRIND" Name="LBNRIND" DataType="text" Length="10" def:Label="Reference Range Indicator"> |
| 163 | + <Description> |
| 164 | + <TranslatedText>Reference Range Indicator</TranslatedText> |
| 165 | + </Description> |
| 166 | + </ItemDef> |
| 167 | + <def:leaf ID="LF.AE" xlink:href="https://github.com/cdisc-org/DataExchange-RWD-Lineage/blob/main/examples/example2/data/sdtm/AE.csv"> |
| 168 | + <def:title>AE.xpt</def:title> |
| 169 | + </def:leaf> |
| 170 | + <def:leaf ID="LF.LB" xlink:href="https://github.com/cdisc-org/DataExchange-RWD-Lineage/blob/main/examples/example2/data/sdtm/LB.csv"> |
| 171 | + <def:title>LB.xpt</def:title> |
| 172 | + </def:leaf> |
| 173 | + <def:leaf ID="LF.LABRESULTS" xlink:href="https://github.com/cdisc-org/DataExchange-RWD-Lineage/blob/main/examples/example2/data/source/LabResults.csv"> |
| 174 | + <def:title>LabResults.csv</def:title> |
| 175 | + </def:leaf> |
| 176 | + <def:leaf ID="LF.RWDLINEAGE" xlink:href="rwd-lineage.xml"> |
| 177 | + <def:title>rwd-lineage.xml</def:title> |
| 178 | + </def:leaf> |
| 179 | + </MetaDataVersion> |
| 180 | + </Study> |
| 181 | +</ODM> |
0 commit comments