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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: derive each adverse event's analysis start date (ASTDT), the
subject's date of first exposure to treatment (TRTSDT) and the
treatment-emergent flag (TRTEMFL).
Input: adverse events carrying each event's start date, and subject-level records carrying each subject's first exposure date.
Variables:
ASTDTwould be the event's start date.TRTSDTwould be the first exposure date of the event's subject.TRTEMFLwould beYwhen the event starts on or after the first exposure date.
Note: every adverse event is required to belong to a subject with a subject-level record, so an event whose subject has none rejects the run with no artifact accepted, instead of leaving its first exposure date and its treatment-emergent flag blank.
How to fix
Add the subject-level record of subject YAMAA-01-104 when the subject belongs
to the analysis population, or remove the event when the subject does not
belong to the study. If events of subjects outside the subject-level data are
acceptable, drop require_match: true from the input:
input:
ADSL: {path: input/adsl.csv, types: {TRTSDT: date}}
The first exposure date is then missing for such an event, its flag is blank,
and the run counts each such event under absent at the date's derivation.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- join
- condition
- unmatched_key
- rule
- LOOKUP-24
expected/error.yaml
phase: join
condition: unmatched_key
spec_paths:
- columns.TRTSDT.derivation.source
rule: LOOKUP-24
context:
intermediate: intermediate(ADSL)
dataset: ADSL
key: [STUDYID, USUBJID]
intermediate_key:
STUDYID: YAMAA-01
USUBJID: YAMAA-01-104
keys:
- STUDYID: YAMAA-01
USUBJID: YAMAA-01-104
AESEQ: 1
Inputs
Under review2 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 | ASTDT | Analysis Start Date | numeric | ISO 8601 | Copy value from AE.AESTDTC. | Predecessor | |
| ADAE | TRTSDT | Date of First Exposure to Treatment | numeric | ISO 8601 | Copy value from ADSL.TRTSDT; a row with no matching record is an error. | Predecessor | |
| ADAE | TRTEMFL | Treatment Emergent Analysis Flag | character | "Y" when ASTDT >= TRTSDT; blank otherwise. | Derived |
| 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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