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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: submit the demographics domain with its data definition, including
each subject's study site (SITEID).
Input: collected demographics, one record per subject.
Variables:
DOMAINisDMon every record.SITEIDis the identifier of the subject's study site.
Note: the study site was added to the domain late, with a label but without the metadata a data definition describes a variable by: its core designation, role, length and origin. The document cannot describe it, so the submission is refused before any document is written; the dataset itself still builds.
How to fix
Give the variable its submission metadata:
- name: SITEID
type: str
label: Study Site Identifier
derivation: RAW.SITEID
submission:
core: Req
role: Record Qualifier
length: 3
origins:
- type: Assigned
source: Sponsor
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- submission_metadata_missing
- rule
- DEFINE-7
expected/error.yaml
phase: validation
condition: submission_metadata_missing
spec_paths:
- sdtm.specs[0].columns.SITEID.submission
rule: DEFINE-7
Inputs
Under review1 source fileinput/dm_raw.csv
Edit2 rows| STUDYID | USUBJID | SITEID |
|---|---|---|
| PAR01 | 101 | |
| PAR01 | 102 |
Unexpected Output
Under review2 rows presented to the failing check - not an accepted artifactexpected/dm.csv
Edit2 rows| DOMAIN | STUDYID | USUBJID | SITEID |
|---|---|---|---|
| DM | PAR01 | 101 | |
| DM | PAR01 | 102 |
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 | 5 | Protocol | Req | Copy value from RAW.STUDYID. | SDTM | 2 | ||
| USUBJID | Unique Subject Identifier | Char | 9 | Assigned | Req | Copy value from RAW.USUBJID. | SDTM | 3 | ||
| SITEID | Study Site Identifier | Char | Collected | Copy value from RAW.SITEID. | 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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