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Summary
EditUnder reviewWhat this benchmark meansREADME.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: one row per adverse event (AE) with an analysis start date/time
(ASTDTM) completed from the collected start, or taken from first exposure
when no start was collected, and the date and time imputation flags
(ASTDTF, ASTTMF).
Input: one spec.yaml over adverse event records carrying the
reported term (AETERM) and the collected start (AESTDTC), which may be a
date and time, a date alone, a year and month, or nothing at all, plus the
first exposure date/time (TRTSDTM) from the subject-level analysis dataset
(ADSL), empty when the subject has no ADSL record.
Variables:
TRTSDTMis the subject's first exposure date/time.ASTDTMis the analysis start date/time. Every part of the start that was not collected takes its earliest value: the first month, the first day and00:00:00, or the first second of a collected minute. A start never collected takesTRTSDTMinstead, and stays empty when that is empty too.ASTDTFnames the first part of the date that was supplied:Ywhen the whole date came from first exposure,Mwhen the month was supplied andDwhen only the day was. It is empty when the date was collected in full and when there is no analysis start.ASTTMFnames the first part of the time that was supplied:Hwhen the whole time was, including a start taken from first exposure,Mwhen the minutes were andSwhen only the seconds were. It is empty when the time was collected to the second and when there is no analysis start.
Note: a start taken from first exposure counts as entirely supplied, even though first exposure itself was collected to the second.
Inputs
Under review2 source filesinput/adsl.csv
Edit2 rows| STUDYID | USUBJID | TRTSDTM |
|---|---|---|
| YAMAA-01 | 2025-03-01T09:00:00 | |
| YAMAA-01 | 2025-04-10T08:30:00 |
input/ae.csv
Edit6 rows| STUDYID | USUBJID | AESEQ | AETERM | AESTDTC |
|---|---|---|---|---|
| YAMAA-01 | 1 | HEADACHE | 2025-03-04T08:30 | |
| YAMAA-01 | 2 | NAUSEA | 2025-03-06 | |
| YAMAA-01 | 3 | FATIGUE | — | |
| YAMAA-01 | 1 | RASH | 2025-04 | |
| YAMAA-01 | 2 | COUGH | — | |
| YAMAA-01 | 1 | PYREXIA | — |
Expected output
Under review6 expected rowsexpected/adae.csv
Edit6 rows| STUDYID | USUBJID | AESEQ | AETERM | AESTDTC | TRTSDTM | ASTDTM | ASTDTF | ASTTMF |
|---|---|---|---|---|---|---|---|---|
| YAMAA-01 | 1 | HEADACHE | 2025-03-04T08:30 | 2025-03-01T09:00:00 | 2025-03-04T08:30:00 | — | S | |
| YAMAA-01 | 2 | NAUSEA | 2025-03-06 | 2025-03-01T09:00:00 | 2025-03-06T00:00:00 | — | H | |
| YAMAA-01 | 3 | FATIGUE | — | 2025-03-01T09:00:00 | 2025-03-01T09:00:00 | Y | H | |
| YAMAA-01 | 1 | RASH | 2025-04 | 2025-04-10T08:30:00 | 2025-04-01T00:00:00 | D | H | |
| YAMAA-01 | 2 | COUGH | — | 2025-04-10T08:30:00 | 2025-04-10T08:30:00 | Y | H | |
| YAMAA-01 | 1 | 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 | TRTSDTM | Datetime of First Exposure to Treatment | numeric | ISO 8601 | Copy value from ADSL.TRTSDTM. | Predecessor | |
| ADAE | ASTDTM | Analysis Start Date/Time | numeric | ISO 8601 | Impute incomplete datetime from AESTDTC, defaulting month=1, day=first, giving each time part the source lacks its earliest value; a missing source takes TRTSDTM, counted as entirely imputed; invalid text is an error. | Derived | |
| ADAE | ASTDTF | Analysis Start Date Imputation Flag | character | Y, M, D | Date imputation flag for ASTDTM: "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 | |
| ADAE | ASTTMF | Analysis Start Time Imputation Flag | character | H, M, S | Time imputation flag for ASTDTM: "H" when the whole time was imputed, "M" when the minutes and seconds were, "S" when only the seconds were; blank when the time was collected to the second. | Derived |
| Variable | Permitted values |
|---|---|
| ASTDTF | Y, M, D |
| ASTTMF | H, M, S |
| 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 |