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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: write how long before the first dose each adverse event began as
ISO 8601 duration text in years, months and days (AEPREDUR), and the
timing text that ends that duration at the first dose date (AETIMING).
Input: one spec.yaml over adverse event records that began on or
before the day of the subject's first dose, each with the event's start date
(AESTDTC) and the date of first dose (RFXSTDTC), held as dates. An
event's start may not have been collected, and a subject may never have been
dosed.
Variables:
AETERMis the adverse event as reported.AEPREDURis the calendar time from the event's start to the first dose: the whole months, written as years and months, then the days left over, so 26 August 2007 to 27 September 2007 isP1M1D, one month to 26 September and one day more. A part that is zero is left out, and an event that began on the day of first dose isP0D. Empty when either date is missing.AETIMINGis that duration, a slash and the first dose date, such asP1M1D/2007-09-27: the period of that length that ends on the first dose date. Empty when the duration is.
Note: a month is a calendar month counted from the start date, never 30
days, and when that month has no such day its last day stands in, so 31
January 2008 to 29 February 2008 is P1M. The same number of days therefore
gives different text from different start dates, which is why the duration
is read from the two dates and never from a count of days. The timing text
is the duration, a slash and the first dose date.
Inputs
Under review1 source fileinput/ae_raw.csv
Edit7 rows| STUDYID | USUBJID | AESEQ | AETERM | AESTDTC | RFXSTDTC |
|---|---|---|---|---|---|
| YAMAA-01 | 1 | HEADACHE | 2007-08-26 | 2007-09-27 | |
| YAMAA-01 | 2 | NAUSEA | 2007-09-27 | 2007-09-27 | |
| YAMAA-01 | 1 | INSOMNIA | 2008-01-31 | 2008-02-29 | |
| YAMAA-01 | 2 | BACK PAIN | 2008-02-20 | 2008-02-29 | |
| YAMAA-01 | 1 | SEASONAL ALLERGY | 2006-11-20 | 2008-03-01 | |
| YAMAA-01 | 2 | DIZZINESS | — | 2008-03-01 | |
| YAMAA-01 | 1 | FATIGUE | 2008-03-10 | — |
Expected output
Under review7 expected rowsexpected/ae.csv
Edit7 rows| STUDYID | USUBJID | AESEQ | AETERM | AESTDTC | RFXSTDTC | AEPREDUR | AETIMING |
|---|---|---|---|---|---|---|---|
| YAMAA-01 | 1 | HEADACHE | 2007-08-26 | 2007-09-27 | P1M1D | P1M1D/2007-09-27 | |
| YAMAA-01 | 2 | NAUSEA | 2007-09-27 | 2007-09-27 | P0D | P0D/2007-09-27 | |
| YAMAA-01 | 1 | INSOMNIA | 2008-01-31 | 2008-02-29 | P1M | P1M/2008-02-29 | |
| YAMAA-01 | 2 | BACK PAIN | 2008-02-20 | 2008-02-29 | P9D | P9D/2008-02-29 | |
| YAMAA-01 | 1 | SEASONAL ALLERGY | 2006-11-20 | 2008-03-01 | P1Y3M10D | P1Y3M10D/2008-03-01 | |
| YAMAA-01 | 2 | DIZZINESS | — | 2008-03-01 | — | — | |
| YAMAA-01 | 1 | FATIGUE | 2008-03-10 | — | — | — |
Human review and assessment
| Variable Name | Variable Label | Type | Length | Controlled Terms or Format | Origin | Core | Conversion Definition | Variable Type | Variable Order | Comments for Define |
|---|---|---|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | Char | Collected | Copy value from AE_RAW.STUDYID. | SDTM | 1 | ||||
| USUBJID | Unique Subject Identifier | Char | Collected | Copy value from AE_RAW.USUBJID. | SDTM | 2 | ||||
| AESEQ | Sequence Number | Num | Collected | Copy value from AE_RAW.AESEQ. | SDTM | 3 | ||||
| AETERM | Reported Term for the Adverse Event | Char | Collected | Copy value from AE_RAW.AETERM. | SDTM | 4 | ||||
| AESTDTC | Start Date/Time of Adverse Event | Char | Collected | Copy value from AE_RAW.AESTDTC. | SDTM | 5 | ||||
| RFXSTDTC | Date/Time of First Study Treatment | Char | Collected | Copy value from AE_RAW.RFXSTDTC. | SDTM | 6 | ||||
| AEPREDUR | Time From Start of Event to First Dose | Char | Derived | Write the calendar time from AE_RAW.AESTDTC to AE_RAW.RFXSTDTC as ISO 8601 duration text: whole months as years and months, then the remaining days, with a leading minus sign when AE_RAW.RFXSTDTC is earlier. | SDTM | 7 | ||||
| AETIMING | Timing of Event Before First Dose | Char | Derived | Fill the template "{AEPREDUR}/{RFXSTDTC}"; a missing field → blank. | SDTM | 8 |
| 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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