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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: one row per subject with the datetimes of first (TRTSDTM) and last
(TRTEDTM) exposure to treatment, built from the treatment start and end
dates (TRTSDT, TRTEDT), and a flag (TRTSTMF) marking that the start's
time of day was supplied.
Input: one spec.yaml over subject-level records carrying the study, the
subject and the treatment start and end dates, held as dates rather than as
collected text. A subject may still be on treatment, with no end date, or
never treated, with neither date.
Variables:
TRTSDTMis the first moment of the start date,00:00:00. A subject with no start date has no start datetime.TRTSTMFisHwhen the start datetime exists: its hour, minute and second were all supplied, because a date carries no time of day. It is empty when there is no start datetime.TRTEDTMis the last moment of the end date,23:59:59, so a comparison against it includes the whole last day of treatment. A subject with no end date has no end datetime.
Note: a date becomes a datetime only by naming which moment of the day is meant; nothing else about the date changes.
Inputs
Under review1 source fileinput/sl.csv
Edit3 rows| STUDYID | USUBJID | TRTSDT | TRTEDT |
|---|---|---|---|
| YAMAA-01 | 2025-03-04 | 2025-06-30 | |
| YAMAA-01 | 2025-03-11 | — | |
| YAMAA-01 | — | — |
Expected output
Under review3 expected rowsexpected/adsl.csv
Edit3 rows| STUDYID | USUBJID | TRTSDT | TRTEDT | TRTSDTM | TRTSTMF | TRTEDTM |
|---|---|---|---|---|---|---|
| YAMAA-01 | 2025-03-04 | 2025-06-30 | 2025-03-04T00:00:00 | H | 2025-06-30T23:59:59 | |
| YAMAA-01 | 2025-03-11 | — | 2025-03-11T00:00:00 | H | — | |
| YAMAA-01 | — | — | — | — | — |
Human review and assessment
| Dataset Name | Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Computational Method | Origin |
|---|---|---|---|---|---|---|---|
| ADSL | STUDYID | Study Identifier | character | Copy value from SL.STUDYID. | Predecessor | ||
| ADSL | USUBJID | Unique Subject Identifier | character | Copy value from SL.USUBJID. | Predecessor | ||
| ADSL | TRTSDT | Date of First Exposure to Treatment | numeric | ISO 8601 | Copy value from SL.TRTSDT. | Predecessor | |
| ADSL | TRTEDT | Date of Last Exposure to Treatment | numeric | ISO 8601 | Copy value from SL.TRTEDT. | Predecessor | |
| ADSL | TRTSDTM | Datetime of First Exposure to Treatment | numeric | ISO 8601 | Impute incomplete datetime from TRTSDT, giving each time part the source lacks its earliest value; a source without a complete date gives blank; invalid text is an error. | Derived | |
| ADSL | TRTSTMF | Time of First Exposure Imputation Flag | character | Time imputation flag for TRTSDTM: "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 | ||
| ADSL | TRTEDTM | Datetime of Last Exposure to Treatment | numeric | ISO 8601 | Impute incomplete datetime from TRTEDT, giving each time part the source lacks its latest value; a source without a complete date gives blank; invalid text is an error. | 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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