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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: show a resubmission level that changes only the list of published variables and the dataset file its data definition names, inheriting every other part of the dataset's layout and of its received description from the original package.
Dataset: dm.csv, SDTM demographics. One record per subject.
Input: two spec files, read root-first:
spec_package.yamlcarries the original package: the age, its units and the sex collected for each subject, published in subject order todm.csv, and the dataset's description as the package received it, a special-purpose demographics dataset of one record per subject held in the SAS transport filedm.xpt;spec_resubmission.yamlis the entry: it names the original package as its parent, publishes its variables without the age units, and names its dataset filedm.json. It writes nothing else.
Variables:
DOMAINis alwaysDM.AGEis the subject's collected age in years.SEXis the subject's collected sex.
Note: a level that changes one part of the published layout or of the received description writes that part alone, and every part it leaves out keeps its inherited value. The resubmission therefore keeps the original file name and subject order, and its data definition describes the shorter variable list with the received description and the new dataset file.
Inputs
Under review1 source fileinput/dm.csv
Edit3 rows| STUDYID | USUBJID | AGE | AGEU | SEX |
|---|---|---|---|---|
| PKG01 | 71 | YEARS | F | |
| PKG01 | 34 | YEARS | M | |
| PKG01 | 58 | YEARS | F |
Expected output
Under review3 expected rowsexpected/define.xml
EditDefine-XMLDefine-XML 2.0.0: PKG01
Example study resubmitting its demographics dataset; PKG-01; SDTM-IG 3.4
| Dataset | Description | Class | Structure | Purpose | Keys | Documentation | Location |
|---|---|---|---|---|---|---|---|
| DM | Demographics | SPECIAL PURPOSE | One record per subject | Tabulation | STUDYID, USUBJID | dm.json |
DM
| Variable | Label / Description | Type | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|
| DOMAIN | Domain Abbreviation | text | 2 | ||
| STUDYID | Study Identifier | text | 5 | ||
| USUBJID | Unique Subject Identifier | text | 9 | ||
| AGE | Age | integer | 3 | ||
| SEX | Sex | text | 1 |
Original source
<?xml version="1.0" encoding="UTF-8"?>
<ODM xmlns="http://www.cdisc.org/ns/odm/v1.3" xmlns:def="http://www.cdisc.org/ns/def/v2.0" xmlns:xlink="http://www.w3.org/1999/xlink" ODMVersion="1.3.2" FileType="Snapshot" FileOID="PKG01.sdtm.Define-XML_2.0" CreationDateTime="2026-10-28T00:00:00" SourceSystem="yamaa" SourceSystemVersion="1.0">
<Study OID="STDY.PKG01">
<GlobalVariables>
<StudyName>PKG01</StudyName>
<StudyDescription>Example study resubmitting its demographics dataset</StudyDescription>
<ProtocolName>PKG-01</ProtocolName>
</GlobalVariables>
<MetaDataVersion OID="MDV.PKG01.sdtm" Name="PKG01 sdtm metadata" def:DefineVersion="2.0.0" def:StandardName="SDTM-IG" def:StandardVersion="3.4">
<ItemGroupDef OID="IG.DM" Name="DM" Domain="DM" Purpose="Tabulation" SASDatasetName="DM" Repeating="No" IsReferenceData="No" def:Structure="One record per subject" def:Class="SPECIAL PURPOSE" def:ArchiveLocationID="LF.DM">
<Description>
<TranslatedText xml:lang="en">Demographics</TranslatedText>
</Description>
<ItemRef ItemOID="IT.DM.DOMAIN" OrderNumber="1" Mandatory="Yes"/>
<ItemRef ItemOID="IT.DM.STUDYID" OrderNumber="2" Mandatory="Yes" KeySequence="1"/>
<ItemRef ItemOID="IT.DM.USUBJID" OrderNumber="3" Mandatory="Yes" KeySequence="2"/>
<ItemRef ItemOID="IT.DM.AGE" OrderNumber="4" Mandatory="No"/>
<ItemRef ItemOID="IT.DM.SEX" OrderNumber="5" Mandatory="Yes"/>
<def:leaf ID="LF.DM" xlink:href="dm.json">
<def:title>dm.json</def:title>
</def:leaf>
</ItemGroupDef>
<ItemDef OID="IT.DM.DOMAIN" Name="DOMAIN" DataType="text" Length="2" SASFieldName="DOMAIN">
<Description>
<TranslatedText xml:lang="en">Domain Abbreviation</TranslatedText>
</Description>
</ItemDef>
<ItemDef OID="IT.DM.STUDYID" Name="STUDYID" DataType="text" Length="5" SASFieldName="STUDYID">
<Description>
<TranslatedText xml:lang="en">Study Identifier</TranslatedText>
</Description>
</ItemDef>
<ItemDef OID="IT.DM.USUBJID" Name="USUBJID" DataType="text" Length="9" SASFieldName="USUBJID">
<Description>
<TranslatedText xml:lang="en">Unique Subject Identifier</TranslatedText>
</Description>
</ItemDef>
<ItemDef OID="IT.DM.AGE" Name="AGE" DataType="integer" Length="3" SASFieldName="AGE">
<Description>
<TranslatedText xml:lang="en">Age</TranslatedText>
</Description>
</ItemDef>
<ItemDef OID="IT.DM.SEX" Name="SEX" DataType="text" Length="1" SASFieldName="SEX">
<Description>
<TranslatedText xml:lang="en">Sex</TranslatedText>
</Description>
</ItemDef>
</MetaDataVersion>
</Study>
</ODM>
expected/dm.csv
Edit3 rows| DOMAIN | STUDYID | USUBJID | AGE | SEX |
|---|---|---|---|---|
| DM | PKG01 | 34 | M | |
| DM | PKG01 | 58 | F | |
| DM | PKG01 | 71 | F |
Human review and assessment
| Variable Name | Variable Label | Type | Length | Controlled Terms or Format | Origin | Core | Conversion Definition | Variable Type | Variable Order | Comments for Define |
|---|
| Version | Date | Author | Description | Reviewer | Sign-off |
|---|---|---|---|---|---|
| 1.7 | 2026-10-20 | yamaa docs build | Read a specification in the 1.0 surface as its 0.5 counterpart; state that missing values stay missing where a mapping declares no missing handler, and leave out a declared missing answer that restates a handler's default | ||
| 1.6 | 2026-10-17 | yamaa docs build | Describe collected date parts written as ISO 8601 date text and times of day counted in seconds since midnight | ||
| 1.5 | 2026-10-17 | yamaa docs build | Name collected precision in words instead of letter codes; state imputation fallbacks, minimum source precision, bounds ignored outside the collected period, and invalid text with no handler as an error; describe date and datetime shifts, imputation flag codes, and partial text giving no date part | ||
| 1.4 | 2026-10-15 | yamaa docs build | State datetime precision codes through the hour and minute, and complete only the time parts a collected datetime lacks | ||
| 1.3 | 2026-09-29 | yamaa docs build | Show study codelist names, external dictionaries, and ISO 8601 formats in variable rows; list the document's codelist values and metadata | ||
| 1.2 | 2026-09-29 | yamaa docs build | Classify ADaM copies from a declared input as Predecessor and recodes as Derived, and SDTM recodes of locally derived columns as Derived | ||
| 1.1 | 2026-09-29 | yamaa docs build | Resolve lookups into the donor record they select, and give every derivation shape a plain-language rule instead of its raw YAML | ||
| 1.0 | yamaa docs build | Initial generation from spec.yaml |
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