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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: build the demographics domain with each subject's death flag
(DTHFL), restricted to the study's no-yes codelist.
Input: collected demographics, one record per subject, and the study's codelists in the project file: the published no-yes response list.
Variables:
DOMAINisDMon every record.DTHFLwould beYfor a subject who died; missing otherwise.
Note: the sponsor added an unknown answer, U, to the published no-yes
list. That list admits no additions: its published values are the whole
list, so the addition contradicts the list it claims to extend, and the run
is rejected before any data is read; no artifact is accepted.
How to fix
Keep the published list as published. When the study needs an unknown answer, declare a sponsor list of its own, without a published standard, and bind the column to it:
codelists:
- codelists:
- id: NYU
name: No Yes Unknown Response
items:
- value: N
- value: Y
- value: U
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- codelist_extension_not_admitted
- rule
- CT-6
expected/error.yaml
phase: validation
condition: codelist_extension_not_admitted
spec_paths:
- codelists[0].codelists[0].items[2].extended
rule: CT-6
context:
codelist: NY
Inputs
Under review1 source fileinput/dm_raw.csv
Edit2 rows| STUDYID | USUBJID | DTHFL |
|---|---|---|
| YAMAA-01 | — | |
| YAMAA-01 | Y |
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 | 2 | Assigned | Req | Set constant value "DM". | SDTM | 1 | ||
| STUDYID | Study Identifier | Char | 8 | Protocol | Req | Copy value from RAW.STUDYID. | SDTM | 2 | ||
| USUBJID | Unique Subject Identifier | Char | 12 | Assigned | Req | Copy value from RAW.USUBJID. | SDTM | 3 | ||
| DTHFL | Subject Death Flag | Char | 1 | No Yes Response | Collected | Exp | Copy value from RAW.DTHFL. | SDTM | 4 |
| Codelist ID | Name | Value | Decode | Codelist NCI alias | Value NCI alias | Extensible | Extended value | SAS format | Dictionary | Version |
|---|---|---|---|---|---|---|---|---|---|---|
| NY | No Yes Response | N | No | |||||||
| NY | No Yes Response | Y | No | |||||||
| NY | No Yes Response | U | No | Yes |
| 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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