yamaa As a clinical trial statistician or programmer, challenge anything in this benchmark: describe a problem in Comments, or propose a fix with the Edit button on any source file.
- Task: Is this a specification error a study team could realistically make, and should the build stop on it rather than continue?
- Inputs: Do they trigger the failure for the reason the summary gives?
- Expected failure: Is this the right error, raised at the right point, and would it tell the programmer what to fix?
The other tabs beside Comments are background for assessment, not under review.
Summary
EditUnder reviewWhat this benchmark meansREADME.mdGoal: derive SEX for one record per subject from the subject's
collected answer.
Input: long-form Operational Data Model (ODM) data with one row per collected item. One subject is asked the sex question at screening and again at baseline, and gives the same answer both times.
Variables:
SEXwould be the subject's answer to the sex question.
That subject's question has two records, one per visit. Two records are not one answer even when they agree, so the run stops rather than choosing one, and it names the visit as the field that tells them apart.
How to fix
Decide which visit's answer is the subject's sex, and read that one:
derivation:
odm: {item: ODM.IT.DM.SEX, event: SCREENING}
Reading the screening answer gives one record for every subject, whether or not the question was asked again.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- derivation
- condition
- odm_not_unique
- requirement
- REQ-1278
expected/error.yaml
phase: derivation
condition: odm_not_unique
spec_paths:
- columns.SEX.derivation.odm
requirement: REQ-1278
context:
item: ODM.IT.DM.SEX
records: 2
differ:
StudyEventOID: [SCREENING, BASELINE]
repeated: false
Inputs
Under review1 source fileinput/odm.csv
Edit5 rows| StudyOID | MetaDataVersionOID | SubjectKey | StudyEventOID | StudyEventRepeatKey | FormOID | FormRepeatKey | ItemGroupOID | ItemGroupRepeatKey | ItemOID | Value |
|---|---|---|---|---|---|---|---|---|---|---|
| STUDY01 | MDV.1 | 001 | SCREENING | 1 | FO.DM | 1 | IG.DM | 1 | IT.DM.SEX | F |
| STUDY01 | MDV.1 | 001 | SCREENING | 1 | FO.DM | 1 | IG.DM | 1 | IT.DM.AGE | 34 |
| STUDY01 | MDV.1 | 002 | SCREENING | 1 | FO.DM | 1 | IG.DM | 1 | IT.DM.SEX | M |
| STUDY01 | MDV.1 | 002 | SCREENING | 1 | FO.DM | 1 | IG.DM | 1 | IT.DM.AGE | 28 |
| STUDY01 | MDV.1 | 001 | BASELINE | 1 | FO.DM | 1 | IG.DM | 1 | IT.DM.SEX | F |
Unexpected Output
Under reviewNo artifact is producedNo fixture files in this directory.
Comments and assessment materials
| Variable Name | Variable Label | Type | Length | Controlled Terms or Format | Origin | Core | Conversion Definition | Variable Type | Variable Order | Comments for Define |
|---|---|---|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | Char | Collected | Copy value from ODM.StudyOID. | SDTM | 1 | ||||
| USUBJID | Unique Subject Identifier | Char | Collected | Copy value from ODM.SubjectKey. | SDTM | 2 | ||||
| SEX | Sex | Char | Collected | Read collected ODM item IT.DM.SEX; no identified record yields blank. | SDTM | 3 |
| Version | Date | Author | Description | Reviewer | Sign-off |
|---|---|---|---|---|---|
| 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 |
Comments
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