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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: carry examination sequence (ZESEQ) and name (ZETERM) in a
sponsor-defined domain and request its submission metadata.
Input: an electronic case report form export lists each subject's examination records with a sequence number and the recorded examination name.
Variables:
ZESEQidentifies the examination record within the subject.ZETERMcarries the examination name as recorded.
Note: the dataset builds, but Define-XML 2.0 cannot represent its declared sponsor-defined status. The submission is refused before its metadata or transport file is published.
How to fix
Use a submission format that preserves the sponsor-defined status, without claiming that this custom dataset follows an implementation-guide definition:
sdtm:
define_version: '2.1.11'
Keep submission.non_standard: true on the custom dataset. The section's
transport request and the collected name's annotated-form reference remain.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- value_not_permitted
- rule
- DEFINE-25
expected/error.yaml
phase: validation
condition: value_not_permitted
rule: DEFINE-25
spec_paths: [datasets.ZE.submission.non_standard]
context:
detail: 'schema_violation: Define-XML 2.0 representation'
value: 2.0 has no IsNonStandard declaration
Inputs
Under review1 source fileinput/examinations.csv
Edit2 rows| USUBJID | SEQ | TERM |
|---|---|---|
| 1 | Slit lamp | |
| 1 | Fundoscopy |
Unexpected Output
Under review2 rows presented to the failing check - not an accepted artifactexpected/ze.csv
Edit2 rows| DOMAIN | STUDYID | USUBJID | ZESEQ | ZETERM |
|---|---|---|---|---|
| ZE | NS01 | 1 | Slit lamp | |
| ZE | NS01 | 1 | Fundoscopy |
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 "ZE". | SDTM | 1 | ||
| STUDYID | Study Identifier | Char | 4 | Protocol | Req | Set constant value "NS01". | SDTM | 2 | ||
| USUBJID | Unique Subject Identifier | Char | 7 | Assigned | Req | Copy value from EYE_RAW.USUBJID. | SDTM | 3 | ||
| ZESEQ | Sequence Number | Num | 8 | Assigned | Req | Copy value from EYE_RAW.SEQ. | SDTM | 4 | ||
| ZETERM | Examination Name | Char | 10 | Collected | Req | Copy value from EYE_RAW.TERM. | SDTM | 5 |
| 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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