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Summary
EditUnder reviewWhat this benchmark meansREADME.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: carry each subject's planned treatment (TRT01P) from the
demographics arm, required for every subject.
Input: collected demographics with the study and subject identifiers and the planned arm.
Variables:
TRT01Pwould be the subject's planned treatment, copied from the demographics arm.
Note: the data definition states that every subject carries a planned treatment, and that statement is checked against the data. A subject whose arm was never recorded rejects the run once the planned treatments are complete, so no artifact is accepted.
How to fix
Lead with the clinical question: a subject in the analysis population was randomized to an arm, so a missing arm is a data issue. Query the site, correct the arm at its source and rerun.
When the analysis genuinely admits subjects without a planned treatment, such as screen failures kept in the dataset, state that in the submission metadata instead:
submission:
core: Req
mandatory: false
origins:
- type: Predecessor
description: DM.ARM
Do not add a separate not-missing check beside mandatory: true; the
metadata already enforces it.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- verification
- condition
- not_missing_failed
- rule
- SUB-11
expected/error.yaml
phase: verification
condition: not_missing_failed
spec_paths:
- columns.TRT01P.submission.mandatory
rule: SUB-11
context:
column: TRT01P
failure_count: 1
keys:
- STUDYID: YAMAA-01
USUBJID: YAMAA-01-102
Inputs
Under review1 source fileinput/dm.csv
Edit3 rows| STUDYID | USUBJID | ARM |
|---|---|---|
| YAMAA-01 | Placebo | |
| YAMAA-01 | — | |
| YAMAA-01 | Drug A |
Unexpected Output
Under reviewNo artifact is producedNo fixture files in this directory.
Human review and assessment
| Dataset Name | Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Computational Method | Origin |
|---|---|---|---|---|---|---|---|
| ADSL | STUDYID | Study Identifier | character | Copy value from DM.STUDYID. | Predecessor | ||
| ADSL | USUBJID | Unique Subject Identifier | character | Copy value from DM.USUBJID. | Predecessor | ||
| ADSL | TRT01P | Planned Treatment for Period 01 | character | Req | Copy value from DM.ARM. | Predecessor |
| 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 |