Review ask
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: flag adverse events (AE) whose onset falls inside a 30-day
post-treatment review window in REVIEWFL.
Input: collected adverse events with onset date (AESTDTC) and the
end of treatment (TRTEDT).
Variables:
REVIEWFLwould containYwhen the onset is no more than 30 days after treatment ended, otherwiseN.
Note: the condition adds 30 days to the treatment end date instead of comparing named values, so the run is rejected before any data is read and no artifact is accepted.
How to fix
Carry the day count in its own column and compare the named value:
- name: WINDOWDY
type: int
label: Days from Treatment End to Onset
derivation:
date_diff:
start: TRTEDT
end: ASTDT
unit: day
- name: REVIEWFL
type: str
label: Protocol Review Flag
derivation:
flag:
condition: "WINDOWDY <= 30"
false_value: "N"
missing: "N"
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- invalid_predicate
- requirement
- REQ-0188
expected/error.yaml
phase: validation
condition: invalid_predicate
spec_paths:
- columns.REVIEWFL.derivation.flag.condition
requirement: REQ-0188
context:
predicate: "ASTDT <= TRTEDT + 30"
Inputs
Under review1 source fileinput/ae.csv
Edit2 rows| STUDYID | USUBJID | AESEQ | AETERM | AESTDTC | TRTEDT |
|---|---|---|---|---|---|
| PILOT7 | 1 | Headache | 2025-03-10 | 2025-03-01 | |
| PILOT7 | 2 | Nausea | 2025-04-15 | 2025-03-01 |
Unexpected Output
Under reviewNo artifact is producedNo fixture files in this directory.
Shaded columns are derived— = missing value
Comments and assessment materials
Not under review
| Dataset Name | Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Computational Method | Origin |
|---|---|---|---|---|---|---|---|
| ADAE | STUDYID | Study Identifier | character | Copy value from AE.STUDYID. | Predecessor | ||
| ADAE | USUBJID | Unique Subject Identifier | character | Copy value from AE.USUBJID. | Predecessor | ||
| ADAE | AESEQ | Sequence Number | numeric | Copy value from AE.AESEQ. | Predecessor | ||
| ADAE | ASTDT | Analysis Start Date | numeric | ISO 8601 | Copy value from AE.AESTDTC. | Predecessor | |
| ADAE | TRTEDT | Date of Last Exposure to Treatment | numeric | ISO 8601 | Copy value from AE.TRTEDT. | Predecessor | |
| ADAE | REVIEWFL | Protocol Review Flag | character | "Y" when ASTDT <= TRTEDT + 30; "N" otherwise; "N" when the condition is unknown. | 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 |
yamaa
Comments
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