As a clinical trial statistician or programmer, answer two short questions in Your review: the task and the inputs and outputs. Agreeing with both approves this benchmark; disagreeing with either needs a comment. Propose a fix with the Edit button on any source file, or add it to your comments.
We suggest spending no more than 5 minutes on a review. The other tabs beside Your review are background for assessment, not under review.
Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: derive each subject's first and last treatment dates (TRTSDT,
TRTEDT) and the number of days on treatment (TRTDURD) in ADSL, from the
demographics (DM) file that an earlier step builds and saves.
Input: two spec files, run in order:
spec_dm.yamlbuilds DM from one comma-separated record per subject and saves it asdm.csv, carrying the first (RFXSTDT) and last (RFXENDT) treatment dates as dates;spec_adsl.yamlis the entry: it reads the saveddm.csv, whose fields hold what the spec that wrote it declares, so its dates are dates without being declared again.
Variables:
TRTSDTandTRTEDTare DM's first and last treatment dates;TRTDURDcounts the days fromTRTSDTtoTRTEDT, both included, so a single treatment day gives one; it stays empty when either date is missing.
Note: a comma-separated file stores every value as text. The dates in
dm.csv are still dates when the entry reads it back, because the spec
that wrote it declares them so, and the day count works on them directly.
Inputs
Under review1 source fileinput/subjects.csv
Edit5 rows| STUDYID | USUBJID | RFXSTDT | RFXENDT |
|---|---|---|---|
| YAMAA-01 | 2024-01-10 | 2024-03-09 | |
| YAMAA-01 | 2024-02-01 | 2024-02-01 | |
| YAMAA-01 | 2024-02-28 | 2024-03-01 | |
| YAMAA-01 | 2024-03-05 | — | |
| YAMAA-01 | — | — |
Expected output
Under review10 expected rowsexpected/adsl.csv
Edit5 rows| STUDYID | USUBJID | TRTSDT | TRTEDT | TRTDURD |
|---|---|---|---|---|
| YAMAA-01 | 2024-01-10 | 2024-03-09 | 60 | |
| YAMAA-01 | 2024-02-01 | 2024-02-01 | 1 | |
| YAMAA-01 | 2024-02-28 | 2024-03-01 | 3 | |
| YAMAA-01 | 2024-03-05 | — | — | |
| YAMAA-01 | — | — | — |
expected/dm.csv
Edit5 rows| STUDYID | USUBJID | RFXSTDT | RFXENDT |
|---|---|---|---|
| YAMAA-01 | 2024-01-10 | 2024-03-09 | |
| YAMAA-01 | 2024-02-01 | 2024-02-01 | |
| YAMAA-01 | 2024-02-28 | 2024-03-01 | |
| YAMAA-01 | 2024-03-05 | — | |
| 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 DM.STUDYID. | Predecessor | ||
| ADSL | USUBJID | Unique Subject Identifier | character | Copy value from DM.USUBJID. | Predecessor | ||
| ADSL | TRTSDT | Date of First Exposure to Treatment | numeric | ISO 8601 | Copy value from DM.RFXSTDT. | Predecessor | |
| ADSL | TRTEDT | Date of Last Exposure to Treatment | numeric | ISO 8601 | Copy value from DM.RFXENDT. | Predecessor | |
| ADSL | TRTDURD | Total Treatment Duration (Days) | numeric | Whole days from DM.RFXSTDT to DM.RFXENDT, counting both endpoints. | 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 |
yamaa