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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: build the trial elements domain, one record per planned element of the trial, with the metadata a data definition describes it by.
Input: the protocol's planned elements, one record per element.
Variables:
DOMAINisTEon every record.ETCDwould be the short code of the element.ELEMENTwould be the description of the element.
Note: the dataset is declared as reference data, which describes the trial rather than any subject, and also as repeating, which means more than one record per subject. Reference data has no subjects to repeat for, so the two declarations contradict each other, and the run is rejected before any data is read; no artifact is accepted.
How to fix
Keep the reference data declaration, and declare the dataset non-repeating:
submission:
label: Trial Elements
class: TRIAL DESIGN
structure: One record per planned Element
repeating: false
reference_data: true
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- reference_data_repeating_conflict
- rule
- SUB-4
expected/error.yaml
phase: validation
condition: reference_data_repeating_conflict
spec_paths:
- submission
rule: SUB-4
Inputs
Under review1 source fileinput/te_raw.csv
Edit3 rows| STUDYID | ETCD | ELEMENT |
|---|---|---|
| YAMAA-01 | SCRN | Screening |
| YAMAA-01 | TRT | Treatment |
| YAMAA-01 | FU | Follow-up |
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 "TE". | SDTM | 1 | ||
| STUDYID | Study Identifier | Char | 8 | Protocol | Req | Copy value from RAW.STUDYID. | SDTM | 2 | ||
| ETCD | Element Code | Char | 4 | Protocol | Req | Copy value from RAW.ETCD. | SDTM | 3 | ||
| ELEMENT | Description of Element | Char | 9 | Protocol | Req | Copy value from RAW.ELEMENT. | 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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