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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: give each adverse event the study-drug dose given nearest in time
to the event's start: the dose's sequence number (EXSEQ), its start date
and time (EXSTDTM) and its amount (EXDOSE).
Input: one spec.yaml over adverse events, each with its sequence
number and start date and time, and exposure records, each with its
sequence number, collected start date or date and time, and dose.
Variables:
ASTDTM: the event's start date and time; empty when none was recorded.EXSEQ: the sequence number of the subject's dose nearest in time to the event's start, before or after it. Empty when the event has no start, or when no dose of the subject has a start to measure from.EXSTDTM: the start of that dose. A dose collected with a date alone starts at midnight of that day.EXDOSE: the amount of that dose.
Note: a dose with no collected start, or one collected only to the month, has no time to measure from and is never chosen, even when it was recorded first; it is passed over rather than taken as the nearest.
Inputs
Under review2 source filesinput/ae.csv
Edit3 rows| STUDYID | USUBJID | AESEQ | ASTDTM |
|---|---|---|---|
| YAMAA-01 | 1 | 2024-04-03T10:00 | |
| YAMAA-01 | 2 | — | |
| YAMAA-01 | 1 | 2024-04-05T16:00 |
input/ex.csv
Edit6 rows| STUDYID | USUBJID | EXSEQ | EXSTDTC | EXDOSE |
|---|---|---|---|---|
| YAMAA-01 | 1 | — | 50 | |
| YAMAA-01 | 2 | 2024-04-03 | 50 | |
| YAMAA-01 | 3 | 2024-04-02T09:00 | 50 | |
| YAMAA-01 | 4 | 2024-04-03T09:30 | 50 | |
| YAMAA-01 | 1 | 2024-04 | 100 | |
| YAMAA-01 | 2 | — | 100 |
Expected output
Under review3 expected rowsexpected/adae.csv
Edit3 rows| STUDYID | USUBJID | AESEQ | ASTDTM | EXSEQ | EXSTDTM | EXDOSE |
|---|---|---|---|---|---|---|
| YAMAA-01 | 1 | 2024-04-03T10:00:00 | 4 | 2024-04-03T09:30:00 | 50 | |
| YAMAA-01 | 2 | — | — | — | — | |
| YAMAA-01 | 1 | 2024-04-05T16:00:00 | — | — | — |
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 | ASTDTM | Analysis Start Date/Time | numeric | ISO 8601 | Copy value from AE.ASTDTM. | Predecessor | |
| ADAE | EXSEQ | Sequence Number of the Nearest Dose | numeric | Take EXSEQ from the EX record matching on STUDYID and USUBJID, and no match yields blank. | Derived | ||
| ADAE | EXSTDTM | Start Date/Time of the Nearest Dose | numeric | ISO 8601 | Take EXSTDTM from the EX record matching on STUDYID and USUBJID, where EXSTDTM is derived as impute incomplete datetime from EXSTDTC, giving each time part the source lacks its earliest value; a source without a complete date gives blank; invalid text is an error, and no match yields blank. | Derived | |
| ADAE | EXDOSE | Dose of the Nearest Dose | numeric | Take EXDOSE from the EX record matching on STUDYID and USUBJID, 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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