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.

  1. Task: Is this a specification error a study team could realistically make, and should the build stop on it rather than continue?
  2. Inputs: Do they trigger the failure for the reason the summary gives?
  3. 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

Lifecycle: reviewedEditUnder review
What this benchmark means
README.md

Goal: 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:

  • REVIEWFL would contain Y when the onset is no more than 30 days after treatment ended, otherwise N.

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

Edit
the run is rejected; no artifact is accepted
expected/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 review
1 source file

input/ae.csv

Edit
2 rows
input/ae.csv
STUDYIDUSUBJIDAESEQAETERMAESTDTCTRTEDT
PILOT71Headache2025-03-102025-03-01
PILOT72Nausea2025-04-152025-03-01

Unexpected Output

Under review
No artifact is produced

No fixture files in this directory.

Shaded columns are derived— = missing value

Comments and assessment materials

Comments

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Mapping spec

Generated from the benchmark YAML; do not edit by hand

Dataset NameVariable NameVariable LabelTypeCodelist/Controlled TermsCoreComputational MethodOrigin
ADAESTUDYIDStudy IdentifiercharacterCopy value from AE.STUDYID.Predecessor
ADAEUSUBJIDUnique Subject IdentifiercharacterCopy value from AE.USUBJID.Predecessor
ADAEAESEQSequence NumbernumericCopy value from AE.AESEQ.Predecessor
ADAEASTDTAnalysis Start DatenumericISO 8601Copy value from AE.AESTDTC.Predecessor
ADAETRTEDTDate of Last Exposure to TreatmentnumericISO 8601Copy value from AE.TRTEDT.Predecessor
ADAEREVIEWFLProtocol Review Flagcharacter"Y" when ASTDT <= TRTEDT + 30; "N" otherwise; "N" when the condition is unknown.Derived
VersionDateAuthorDescriptionReviewerSign-off
1.32026-09-29yamaa docs buildShow study codelist names, external dictionaries, and ISO 8601 formats in variable rows; list the document's codelist values and metadata
1.22026-09-29yamaa docs buildClassify ADaM copies from a declared input as Predecessor and recodes as Derived, and SDTM recodes of locally derived columns as Derived
1.12026-09-29yamaa docs buildResolve lookups into the donor record they select, and give every derivation shape a plain-language rule instead of its raw YAML
1.0yamaa docs buildInitial generation from spec.yaml