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: carry the recorded sex (SEX) for each subject from
collected demographics, accepting only M, F, and U.
Input: collected demographics with study and subject
identifiers and recorded sex (SEX).
Variables:
SEXis the subject's recorded sex, copied from collectedSEX. A missing value remains missing and passes the final check; any other value must beM,F, orU.
A non-missing code outside the accepted set is rejected after the dataset is completed, so no artifact is accepted.
How to fix
Confirm the code against the study's sex coding convention. Correct X at
the governed source when it is a data-entry error. If X is an intentional
study code, document that policy and add it to the anchored accepted set
on the SEX column:
verifications:
- matches:
pattern: '^[MFUX]$'
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- verification
- condition
- matches_failed
- requirement
- REQ-0379
expected/error.yaml
phase: verification
condition: matches_failed
spec_paths:
- columns.SEX.verifications[0].matches
requirement: REQ-0379
context:
column: SEX
failure_count: 1
keys:
- STUDYID: PILOT7
USUBJID: P7-952
Inputs
Under review1 source fileinput/dm.csv
Edit2 rows| STUDYID | USUBJID | SEX |
|---|---|---|
| PILOT7 | M | |
| PILOT7 | X |
Unexpected Output
Under review2 rows presented to the failing check - not an accepted artifactexpected/adsl.csv
Edit2 rows| STUDYID | USUBJID | SEX |
|---|---|---|
| PILOT7 | M | |
| PILOT7 | X |
Comments and assessment materials
| 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 | SEX | Sex | character | Copy value from DM.SEX. | Predecessor |
| 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 |
yamaa
Comments
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