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?
The other tabs beside Comments are background for assessment, not under review.
Summary
README.mdGoal: build one analysis row for each collected laboratory
result, carrying SEX and AVAL through and adding ANRHI from
a reference table of limits by test and sex.
Input: collected laboratory results carrying the collected
result (LBSTRESN), test code (LBTESTCD), and sex (SEX),
plus the reference table of upper limits by test code and sex.
Variables:
SEXwould contain the subject's sex, carried fromSEXin the laboratory results.AVALwould contain the collected numeric result, carried fromLBSTRESN.ANRHIwould be the upper limit of normal taken from the reference row whose test code matches the collected test code and whose sex matches the subject's sex; missing when no row matches or the sex is missing.
Note: the reference table is absent from the study, so the run is rejected before any data is read and no artifact is accepted.
How to fix
Decide first whether the study should carry reference limits: add the approved table when the limits exist, and state an explicit policy only when the study genuinely has none.
Add the approved limit table to the study under the name it is read by,
input/lbref.csv, with one row per test and sex:
LBTESTCD,SEX,ANRHI
ALT,F,33
ALT,M,41
If a study genuinely has no reference limits for a test, say so explicitly by supplying a result for the unmatched case rather than by leaving the table out. A file that is simply absent cannot be told apart from one that was forgotten.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- resource_path_missing
- requirement
- REQ-0785
expected/error.yaml
phase: validation
condition: resource_path_missing
spec_paths:
- input.LBREF.path
requirement: REQ-0785
context:
dataset: LBREF
path: input/lbref.csv
Inputs
Under review1 source fileinput/lb.csv
Edit2 rows| STUDYID | USUBJID | LBTESTCD | SEX | LBSTRESN |
|---|---|---|---|---|
| PILOT7 | ALT | F | 42 | |
| PILOT7 | ALT | M | 58 |
Unexpected Output
Under reviewNo artifact is producedNo fixture files in this directory.
Comments and assessment materials
| Dataset Name | Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Computational Method | Origin |
|---|---|---|---|---|---|---|---|
| ADLB | STUDYID | Study Identifier | character | Copy value from LB.STUDYID. | Predecessor | ||
| ADLB | USUBJID | Unique Subject Identifier | character | Copy value from LB.USUBJID. | Predecessor | ||
| ADLB | PARAMCD | Parameter Code | character | Copy value from LB.LBTESTCD. | Predecessor | ||
| ADLB | SEX | Sex | character | Copy value from LB.SEX. | Predecessor | ||
| ADLB | AVAL | Analysis Value | numeric | Copy value from LB.LBSTRESN. | Predecessor | ||
| ADLB | ANRHI | Analysis Normal Range Upper Limit | numeric | Take ANRHI from the LBREF record whose LBTESTCD equals PARAMCD and SEX equals SEX, and a row with no match is an error. | Derived |
| 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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