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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 start date
(ASTDT) taken from a collected start that may carry a time of day, and a
flag (ASTDTF) marking how much of the date was supplied.
Input: one spec.yaml over adverse event records carrying the reported
term (AETERM) and the collected start (AESTDTC): a date with a time to the
second, minute or hour, a date alone, a year and month, a year alone, or
nothing at all.
Variables:
ASTDTis the analysis start date. A start carrying a complete date gives that calendar date, and its time of day plays no part. A year and month is completed to the first of the month, and a year alone to 1 January. A start never collected gives no analysis date.ASTDTFisDwhen the day was supplied andMwhen the month and day were supplied. It is empty when the date was collected in full, with or without a time, and when there is no analysis date.
Note: collected text is read in every truncated form the standard allows, so a start that carries a time completes to its calendar date exactly as a date alone does.
Inputs
Under review1 source fileinput/ae.csv
Edit7 rows| STUDYID | USUBJID | AESEQ | AETERM | AESTDTC |
|---|---|---|---|---|
| YAMAA-01 | 1 | HEADACHE | 2025-03-04T08:30:15 | |
| YAMAA-01 | 2 | NAUSEA | 2025-03-05T14:20 | |
| YAMAA-01 | 3 | DIZZINESS | 2025-03-06T09 | |
| YAMAA-01 | 4 | FATIGUE | 2025-03-07 | |
| YAMAA-01 | 1 | RASH | 2025-04 | |
| YAMAA-01 | 2 | COUGH | 2025 | |
| YAMAA-01 | 3 | PYREXIA | — |
Expected output
Under review7 expected rowsexpected/adae.csv
Edit7 rows| STUDYID | USUBJID | AESEQ | AETERM | AESTDTC | ASTDT | ASTDTF |
|---|---|---|---|---|---|---|
| YAMAA-01 | 1 | HEADACHE | 2025-03-04T08:30:15 | 2025-03-04 | — | |
| YAMAA-01 | 2 | NAUSEA | 2025-03-05T14:20 | 2025-03-05 | — | |
| YAMAA-01 | 3 | DIZZINESS | 2025-03-06T09 | 2025-03-06 | — | |
| YAMAA-01 | 4 | FATIGUE | 2025-03-07 | 2025-03-07 | — | |
| YAMAA-01 | 1 | RASH | 2025-04 | 2025-04-01 | D | |
| YAMAA-01 | 2 | COUGH | 2025 | 2025-01-01 | M | |
| YAMAA-01 | 3 | PYREXIA | — | — | — |
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 | ASTDT | Analysis Start Date | numeric | ISO 8601 | Impute incomplete date from AESTDTC, defaulting month=1, day=first; 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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