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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: derive each subject's date of first exposure to treatment
(TRTSDT) and date of death (DTHDT), each left blank when the subject has
no record to read it from.
Input: one spec.yaml over demographics, exposure records carrying each
administration's start date and dose, and disposition records carrying the
disposition event and its date.
Variables:
TRTSDTis the start date of the subject's earliest administration with a dose above zero; a subject whose administrations all have a zero dose, or who has none, has no first exposure date.DTHDTis the date of the subject's death disposition record; a subject with no death record has no date of death.
Note: a subject without a record to read is kept, with the date blank, instead of stopping the run, and each such blank is counted so the run reports how often it happened.
Inputs
Under review3 source filesinput/dm.csv
Edit3 rows| STUDYID | USUBJID |
|---|---|
| YAMAA-01 | |
| YAMAA-01 | |
| YAMAA-01 |
input/ds.csv
Edit3 rows| STUDYID | USUBJID | DSSEQ | DSDECOD | DSSTDTC |
|---|---|---|---|---|
| YAMAA-01 | 1 | COMPLETED | 2025-03-31 | |
| YAMAA-01 | 1 | DEATH | 2025-02-14 | |
| YAMAA-01 | 1 | WITHDRAWAL BY SUBJECT | 2025-01-10 |
input/ex.csv
Edit4 rows| STUDYID | USUBJID | EXSEQ | EXSTDTC | EXDOSE |
|---|---|---|---|---|
| YAMAA-01 | 1 | 2025-01-06 | 0 | |
| YAMAA-01 | 2 | 2025-01-13 | 50 | |
| YAMAA-01 | 3 | 2025-01-20 | 50 | |
| YAMAA-01 | 1 | 2025-01-08 | 0 |
Expected output
Under review3 expected rowsexpected/adsl.csv
Edit3 rows| STUDYID | USUBJID | TRTSDT | DTHDT |
|---|---|---|---|
| YAMAA-01 | 2025-01-13 | — | |
| YAMAA-01 | — | 2025-02-14 | |
| YAMAA-01 | — | — |
Human review and assessment
| Dataset Name | Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Computational Method | Origin |
|---|---|---|---|---|---|---|---|
| ADSL | STUDYID | Study Identifier | character | Copy value from DM.STUDYID. | Predecessor | ||
| ADSL | USUBJID | Unique Subject Identifier | character | Copy value from DM.USUBJID. | Predecessor | ||
| ADSL | TRTSDT | Date of First Exposure to Treatment | numeric | ISO 8601 | Copy value from EX.EXSTDTC where EX.EXDOSE > 0, keeping the first ordered by EX.EXSTDTC. | Predecessor | |
| ADSL | DTHDT | Date of Death | numeric | ISO 8601 | Take DSSTDTC from the DS record matching on STUDYID and USUBJID, where DS.DSDECOD = 'DEATH', and no match yields blank. | 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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