As a clinical trial statistician or programmer, challenge anything in this benchmark: describe a problem in Comments, or propose a fix with the Edit button on any source file.
- Task: Is this a specification error a study team could realistically make, and should the build stop on it rather than continue?
- Inputs: Do they trigger the failure for the reason the summary gives?
- Expected failure: Is this the right error, raised at the right point, and would it tell the programmer what to fix?
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Summary
README.mdGoal: 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:
date: 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
- requirement
- REQ-0121
expected/error.yaml
phase: validation
condition: incomparable_range_types
spec_paths:
- intermediates[0].between
requirement: REQ-0121
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.
Comments and assessment materials
| 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 |
|---|---|---|---|---|---|
| 1.3 | 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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Comments
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