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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: carry each subject's first dose date (TRTSDT) onto every
adverse event record.
Input: collected adverse events, one record per event, and a copy of
the subject-level analysis dataset as it was last saved. spec_adsl.yaml
produces that dataset and describes its columns.
Variables:
AESEQwould be the collected sequence number of the event.AEDECODwould be the dictionary-derived term as collected.TRTSDTwould be the subject's first dose date from the subject-level dataset.
Note: the copy was saved before its producer added the first dose date,
so the file has no TRTSDT column, while its description promises one. The
file no longer matches what describes it, so the run is rejected and no
artifact is accepted.
How to fix
Rebuild and save the subject-level dataset from spec_adsl.yaml, then read
the file that build saves instead of the old copy:
ADSL:
path: adsl.csv
schema: spec_adsl.yaml
key: [STUDYID, USUBJID]
Do not edit the old copy's header by hand: only a new build makes a saved file match its producer.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- producer_contract_mismatch
- rule
- INPUT-11
expected/error.yaml
phase: validation
condition: producer_contract_mismatch
spec_paths:
- input.ADSL.schema
- input.ADSL.path
rule: INPUT-11
context:
dataset: ADSL
expected: [STUDYID, USUBJID, AGE, TRTSDT]
missing: [TRTSDT]
extra: []
reordered: false
Inputs
Under review3 source filesUnexpected 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 |
|---|---|---|---|---|---|---|---|
| ADAE | STUDYID | Study Identifier | character | Copy value from AE.STUDYID. | Predecessor | ||
| ADAE | USUBJID | Unique Subject Identifier | character | Copy value from AE.USUBJID. | Predecessor | ||
| ADAE | AESEQ | Sequence Number | numeric | Copy value from AE.AESEQ. | Predecessor | ||
| ADAE | AEDECOD | Dictionary-Derived Term | character | Copy value from AE.AEDECOD. | Predecessor | ||
| ADAE | TRTSDT | Date of First Exposure to Treatment | numeric | ISO 8601 | Copy value from ADSL.TRTSDT. | 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 |
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