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: derive REVIEWFL to flag adverse events (AEs) for
protocol review.
Input: collected adverse event records carrying the collected
onset date (AESTDTC) alongside the study, subject, and event
sequence identifiers.
Variables:
REVIEWFLwould containYwhen the event onset date is on or after 2025-01-01 andNotherwise, including when no onset date was collected.
Note: the decision names UNKNOWNDT instead of the onset date,
and no declared column provides it, so the run is rejected before
any data is read and no artifact is accepted.
How to fix
Use the declared analysis start date in the condition:
derivation:
flag:
condition: "ASTDT >= DATE '2025-01-01'"
false_value: "N"
missing: "N"
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- unknown_field
- requirement
- REQ-0189
expected/error.yaml
phase: validation
condition: unknown_field
spec_paths:
- columns.REVIEWFL.derivation.flag.condition
requirement: REQ-0189
context:
identifier: UNKNOWNDT
Inputs
Under review1 source fileinput/ae.csv
Edit1 row| STUDYID | USUBJID | AESEQ | AESTDTC |
|---|---|---|---|
| PILOT7 | 1 | 2025-01-15 |
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 |
|---|---|---|---|---|---|---|---|
| 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 | REVIEWFL | Protocol Review Flag | character | "Y" when UNKNOWNDT >= DATE '2025-01-01'; "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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