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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: build one Demographics (DM) record per subject with the sex
(SEX) collected on the demographics form.
Input: an export from an older electronic data capture (EDC) system written as an Operational Data Model (ODM) 1.2 XML file, whose root element names the ODM 1.2 namespace.
Variables:
SEXwould be the subject's collected sex code.
Only ODM 1.3 and 2.0 documents are read. ODM 1.2 is an earlier version of the standard, and reading its elements as if they followed 1.3 could give a collected value a meaning the export never gave it. The input is rejected while it is read, and no artifact is accepted.
How to fix
Export the clinical data as ODM 1.3 or 2.0. The root element of such an export names the matching namespace and version:
<ODM xmlns="http://www.cdisc.org/ns/odm/v1.3" ODMVersion="1.3.2"
FileType="Snapshot">
Do not edit the namespace of a 1.2 file by hand; the version is a property of how the file was written, not a label.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- ingest
- condition
- source_odm_document_unsupported
- rule
- ODM-1
expected/error.yaml
phase: ingest
condition: source_odm_document_unsupported
spec_paths:
- input.ODM.path
rule: ODM-1
context:
dataset: ODM
path: input/odm.xml
Inputs
Under review1 source fileinput/odm.xml
Edit<?xml version="1.0" encoding="UTF-8"?>
<ODM xmlns="http://www.cdisc.org/ns/odm/v1.2"
ODMVersion="1.2.1"
FileType="Snapshot"
FileOID="STUDY01.SNAPSHOT.20260302"
CreationDateTime="2026-03-02T09:15:00+00:00">
<ClinicalData StudyOID="STUDY01" MetaDataVersionOID="MDV.1">
<SubjectData SubjectKey="101">
<StudyEventData StudyEventOID="SE.SCREENING">
<FormData FormOID="F.DM">
<ItemGroupData ItemGroupOID="IG.DM">
<ItemData ItemOID="IT.DM.SEX" Value="M"/>
</ItemGroupData>
</FormData>
</StudyEventData>
</SubjectData>
<SubjectData SubjectKey="102">
<StudyEventData StudyEventOID="SE.SCREENING">
<FormData FormOID="F.DM">
<ItemGroupData ItemGroupOID="IG.DM">
<ItemData ItemOID="IT.DM.SEX" Value="F"/>
</ItemGroupData>
</FormData>
</StudyEventData>
</SubjectData>
</ClinicalData>
</ODM>
Unexpected Output
Under reviewNo artifact is producedNo fixture files in this directory.
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| DOMAIN | Domain Abbreviation | Char | Assigned | Set constant value "DM". | SDTM | 1 | ||||
| STUDYID | Study Identifier | Char | Collected | Copy value from ODM.StudyOID. | SDTM | 2 | ||||
| USUBJID | Unique Subject Identifier | Char | Derived | Fill the template "{ODM.StudyOID}-{ODM.SubjectKey}". | SDTM | 3 | ||||
| SEX | Sex | Char | Collected | Read collected ODM item IT.DM.SEX; no identified record yields blank. | SDTM | 4 |
| 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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