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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/time
(ASTDTM) completed from the collected start, and the date and time
imputation flags (ASTDTF, ASTTMF) naming the first part of each that
was supplied.
Input: one spec.yaml over adverse event records carrying the reported
term (AETERM) and the collected start (AESTDTC), collected to the year,
month, day, hour, minute or second.
Variables:
ASTDTMis the analysis start date/time. Every part the start did not collect takes its earliest value: January, the first day, and00for each part of the time.ASTDTFisMwhen the month and day were supplied andDwhen only the day was; empty when the date was collected in full.ASTTMFisHwhen the whole time was supplied, which includes every start collected only to a year, a month or a day,Mwhen the minutes and seconds were andSwhen only the seconds were; empty when the time was collected to the second.
Note: both flags are read from the completed date/time, which keeps how much of it was collected; the completed values themselves look alike.
Inputs
Under review1 source fileinput/ae.csv
Edit6 rows| STUDYID | USUBJID | AESEQ | AETERM | AESTDTC |
|---|---|---|---|---|
| YAMAA-01 | 1 | HEADACHE | 2025 | |
| YAMAA-01 | 2 | NAUSEA | 2025-03 | |
| YAMAA-01 | 3 | DIZZINESS | 2025-03-04 | |
| YAMAA-01 | 4 | FATIGUE | 2025-03-05T14 | |
| YAMAA-01 | 5 | RASH | 2025-03-06T09:30 | |
| YAMAA-01 | 6 | COUGH | 2025-03-07T10:15:30 |
Expected output
Under review6 expected rowsexpected/adae.csv
Edit6 rows| STUDYID | USUBJID | AESEQ | AETERM | AESTDTC | ASTDTM | ASTDTF | ASTTMF |
|---|---|---|---|---|---|---|---|
| YAMAA-01 | 1 | HEADACHE | 2025 | 2025-01-01T00:00:00 | M | H | |
| YAMAA-01 | 2 | NAUSEA | 2025-03 | 2025-03-01T00:00:00 | D | H | |
| YAMAA-01 | 3 | DIZZINESS | 2025-03-04 | 2025-03-04T00:00:00 | — | H | |
| YAMAA-01 | 4 | FATIGUE | 2025-03-05T14 | 2025-03-05T14:00:00 | — | M | |
| YAMAA-01 | 5 | RASH | 2025-03-06T09:30 | 2025-03-06T09:30:00 | — | S | |
| YAMAA-01 | 6 | COUGH | 2025-03-07T10:15:30 | 2025-03-07T10:15:30 | — | — |
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 | 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; invalid text is an error. | Derived | |
| ADAE | ASTDTF | Analysis Start Date Imputation Flag | character | 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 | 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 |
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