As a clinical trial statistician or programmer, answer two short questions in Your review: the task and the inputs. 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: attach the epoch (EPOCH) containing each collected
vital-sign date.
Input: vital-sign records carrying a collected calendar date
(VSDTC), plus an epoch table carrying a period name (EPOCH)
with integer day bounds (DYLO, DYHI).
Variables:
EPOCHwould be the period name from the epoch-table row whose day range contains the visit, and blank when no range does. A calendar date cannot be ordered directly against integer day bounds, so the run is rejected before any data is read and no artifact is accepted.
How to fix
Prefer comparing the collected date with date bounds directly: match
VSDTC between the subject's own element start and end dates
(SESTDTC, SEENDTC from the subject-elements data), which is how
SDTM assigns EPOCH:
between: {value: VSDTC, lower: SESTDTC, upper: SEENDTC}
Only when the epoch table must stay study-day based, derive the
integer study day from the date and the subject's reference start
date (RFSTDTC, read from demographics into a date column), then
compare that value with the integer bounds:
- name: VSDY
type: int
derivation:
study_day:
source: VSDTC
reference: RFSTDTC
between: {value: VSDY, lower: DYLO, upper: DYHI}
The study-day route needs demographics as an extra input, and it gives every subject the same epoch boundaries.
sdtm-vs-study-day attaches the epoch this way.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- incomparable_range_types
- rule
- LOOKUP-9
expected/error.yaml
phase: validation
condition: incomparable_range_types
spec_paths:
- intermediates.EPOCHDEF.between
rule: LOOKUP-9
context:
intermediate: EPOCHDEF
value_type: date
lower_type: int
upper_type: int
Inputs
Under review2 source filesUnexpected Output
Under reviewNo artifact is producedNo fixture files in this directory.
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 VS_RAW.STUDYID. | SDTM | 1 | ||||
| USUBJID | Unique Subject Identifier | Char | Collected | Copy value from VS_RAW.USUBJID. | SDTM | 2 | ||||
| VSSEQ | Sequence Number | Num | Collected | Copy value from VS_RAW.VSSEQ. | SDTM | 3 | ||||
| VSDTC | Date/Time of Measurements | Char | ISO 8601 | Collected | Copy value from VS_RAW.VSDTC. | SDTM | 4 | |||
| EPOCH | Epoch | Char | Derived | Take EPOCH from the EPOCHS record matching on STUDYID, where VSDTC falls within DYLO to DYHI, and a row with no match is an error. | SDTM | 5 |
| 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