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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: give every adverse event record its subject's age (AGE), sex
(SEX), planned arm (ARM) and date of first exposure to treatment
(TRTSDT) from the subject-level analysis dataset (ADSL), each under the
name, type and label ADSL gives it.
Input: two spec files, run in order:
spec_adsl.yamlbuilds ADSL from collected demographics, one record per subject with the first exposure date as text, and saves it asadsl.csv;spec_adae.yamlis the entry: it reads adverse event records carrying the reported term (AETERM) and the savedadsl.csv, and names the four variables to take from it without declaring them again.
Variables:
AGE,SEXandARMare the subject's age in years, sex and planned arm, repeated on each of the subject's events;TRTSDTis the date of the subject's first exposure to treatment, still a date on the events; it stays empty for a subject never exposed, such as a screen failure.
Note: a variable taken by name from ADSL keeps everything the spec that builds ADSL declares for it, so the two datasets cannot disagree on its type or label. Each event finds its subject's one ADSL record by the study and subject identifiers; a subject without adverse events adds no event record.
Inputs
Under review2 source filesExpected output
Under review6 expected rowsexpected/adae.csv
Edit3 rows| STUDYID | USUBJID | AESEQ | AETERM | AGE | SEX | ARM | TRTSDT |
|---|---|---|---|---|---|---|---|
| YAMAA-01 | 1 | HEADACHE | 64 | F | Drug A | 2026-02-02 | |
| YAMAA-01 | 2 | NAUSEA | 64 | F | Drug A | 2026-02-02 | |
| YAMAA-01 | 1 | DIZZINESS | 58 | F | Screen Failure | — |
expected/adsl.csv
Edit3 rows| STUDYID | USUBJID | AGE | SEX | ARM | TRTSDT |
|---|---|---|---|---|---|
| YAMAA-01 | 64 | F | Drug A | 2026-02-02 | |
| YAMAA-01 | 47 | M | Placebo | 2026-02-04 | |
| YAMAA-01 | 58 | F | Screen Failure | — |
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 | AETERM | Reported Term for the Adverse Event | character | Copy value from AE.AETERM. | 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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