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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: one row per adverse event (AE) with an analysis end date
(AENDT), and an analysis start date (ASTDT) completed from a partial
start no earlier than first exposure and no later than the event's end, and
a flag (ASTDTF) marking how much of the start date was supplied.
Input: one spec.yaml over adverse event records carrying the reported
term (AETERM) and the collected start and end (AESTDTC, AEENDTC): a
full date, a year and month, a year alone, or no end at all, plus the first
exposure date (TRTSDT) from the subject-level analysis dataset (ADSL).
Variables:
TRTSDTis the subject's first exposure date.ASTDTis the analysis start date. A fully collected start is used as it stands. A partial start takes the first day it allows, then moves up toTRTSDTand back toAENDTwherever either date falls inside the collected month or year; a date outside it moves nothing. When both fall inside and first exposure is the later, the start takes the end date, so a start is never placed after the event ended.ASTDTFisDwhen the day was supplied andMwhen the month and day were supplied, whether or not first exposure or the end then moved the date. It is empty when the start was collected in full.AENDTis the analysis end date: a fully collected end as it stands, a year and month completed to the last day of that month, and a year alone to 31 December; empty when no end was collected.
Note: when first exposure and the end both fall inside the collected period and cross, the end wins, so the start never follows the end it belongs to and is never left empty.
Inputs
Under review2 source filesinput/adsl.csv
Edit2 rows| STUDYID | USUBJID | TRTSDT |
|---|---|---|
| YAMAA-01 | 2025-03-20 | |
| YAMAA-01 | 2025-05-02 |
input/ae.csv
Edit6 rows| STUDYID | USUBJID | AESEQ | AETERM | AESTDTC | AEENDTC |
|---|---|---|---|---|---|
| YAMAA-01 | 1 | HEADACHE | 2025-03 | 2025-03-25 | |
| YAMAA-01 | 2 | NAUSEA | 2025-03 | 2025-03-10 | |
| YAMAA-01 | 3 | RASH | 2025-02 | 2025-02-15 | |
| YAMAA-01 | 4 | COUGH | 2025-03-12 | 2025-03-14 | |
| YAMAA-01 | 1 | FATIGUE | 2025-05 | — | |
| YAMAA-01 | 2 | PYREXIA | 2025 | 2025-04 |
Expected output
Under review6 expected rowsexpected/adae.csv
Edit6 rows| STUDYID | USUBJID | AESEQ | AETERM | AESTDTC | AEENDTC | TRTSDT | ASTDT | ASTDTF | AENDT |
|---|---|---|---|---|---|---|---|---|---|
| YAMAA-01 | 1 | HEADACHE | 2025-03 | 2025-03-25 | 2025-03-20 | 2025-03-20 | D | 2025-03-25 | |
| YAMAA-01 | 2 | NAUSEA | 2025-03 | 2025-03-10 | 2025-03-20 | 2025-03-10 | D | 2025-03-10 | |
| YAMAA-01 | 3 | RASH | 2025-02 | 2025-02-15 | 2025-03-20 | 2025-02-01 | D | 2025-02-15 | |
| YAMAA-01 | 4 | COUGH | 2025-03-12 | 2025-03-14 | 2025-03-20 | 2025-03-12 | — | 2025-03-14 | |
| YAMAA-01 | 1 | FATIGUE | 2025-05 | — | 2025-05-02 | 2025-05-02 | D | — | |
| YAMAA-01 | 2 | PYREXIA | 2025 | 2025-04 | 2025-05-02 | 2025-04-30 | M | 2025-04-30 |
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 | ||
| ADAE | AESTDTC | Start Date/Time of Adverse Event | character | Copy value from AE.AESTDTC. | Predecessor | ||
| ADAE | AEENDTC | End Date/Time of Adverse Event | character | Copy value from AE.AEENDTC. | Predecessor | ||
| ADAE | TRTSDT | Date of First Exposure to Treatment | numeric | ISO 8601 | Copy value from ADSL.TRTSDT. | Predecessor | |
| ADAE | AENDT | Analysis End Date | numeric | ISO 8601 | Impute incomplete date from AEENDTC, defaulting month=12, day=last; invalid text is an error. | Derived | |
| ADAE | ASTDT | Analysis Start Date | numeric | ISO 8601 | Impute incomplete date from AESTDTC, defaulting month=1, day=first, never before TRTSDT, never after AENDT; a bound outside the collected period is ignored, and AENDT wins over a later TRTSDT; invalid text is an error. | Derived | |
| ADAE | ASTDTF | Analysis Start Date Imputation Flag | character | D, M | Date imputation flag for ASTDT: "Y" when the whole date was imputed, "M" when the month and day were, "D" when only the day was; blank when the date was collected in full. | Derived |
| Variable | Permitted values |
|---|---|
| ASTDTF | D, M |
| 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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