As a clinical trial statistician or programmer, answer two short questions in Your review: the task and the inputs. Agreeing with both approves this benchmark; disagreeing with either needs a comment. Propose a fix with the Edit button on any source file, or add it to your comments.
We suggest spending no more than 5 minutes on a review. The other tabs beside Your review are background for assessment, not under review.
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: the electronic data capture (EDC) system's export as an Operational Data Model (ODM) 1.3 XML file whose first line declares the Latin-1 (ISO-8859-1) character encoding instead of UTF-8.
Variables:
SEXwould be the subject's collected sex code.
The same bytes spell different accented letters in Latin-1 and in UTF-8, so a site or investigator name read in the wrong encoding comes out as a different name. Only UTF-8 is read, and the file states that it is not UTF-8, so the input is rejected while it is read, and no artifact is accepted.
How to fix
Export the file again from the EDC system as UTF-8, so that its first line reads:
<?xml version="1.0" encoding="UTF-8"?>
Do not change only that line: the bytes of every accented letter would stay in Latin-1 and be read as other letters.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- ingest
- condition
- source_odm_xml_unsupported
- rule
- ODM-1
expected/error.yaml
phase: ingest
condition: source_odm_xml_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="ISO-8859-1"?>
<ODM xmlns="http://www.cdisc.org/ns/odm/v1.3"
ODMVersion="1.3.2"
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 |
yamaa