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?

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Summary

Lifecycle: reviewedEditUnder review
What this benchmark means
README.md

Goal: derive cumulative dose (DOSECUM) and relative dose intensity (RDI) by subject and treatment.

Input: a subject-treatment inventory carrying the dose unit (EXDOSU), with component exposure records carrying the treatment (EXTRT), the administered dose (EXDOSE), and the planned dose (EXPLDOS) on each administration record.

Variables:

  • EXTRT names the treatment component, and EXDOSU is the unit that component is measured in.
  • DOSECUM is the total administered dose across the component's exposure records.
  • RDI is meant to be that total as a percentage of the planned dose. The planned dose is recorded on each administration record rather than once for the treatment, so dividing the total by it leaves open which record supplies the denominator, and that choice would decide the answer. The run is rejected before any data is read, and no artifact is accepted.

How to fix

First decide what the denominator means. If each exposure row carries its own planned administration, total both actual and planned dose:

derivation:
  aggregate:
    expr: >-
      100 * SUM(EX.EXDOSE) / NULLIF(SUM(EX.EXPLDOS), 0)

If the denominator is one treatment-level plan, store it once in the subject treatment source, bind it to a numeric column, and compute RDI from that column and DOSECUM. Do not select one exposure row arbitrarily.

Expected failure

Edit
the run is rejected; no artifact is accepted
expected/error.yaml
phase
validation
condition
aggregate_identifier_not_grouped
requirement
REQ-0503
expected/error.yaml
phase: validation
condition: aggregate_identifier_not_grouped
spec_paths:
  - columns.RDI.derivation.aggregate.expr
requirement: REQ-0503
context:
  dataset: EX
  identifier: EX.EXPLDOS

Inputs

Under review
2 source files

input/ex.csv

Edit
5 rows
input/ex.csv
STUDYIDUSUBJIDEXTRTEXSEQEXDOSEEXPLDOS
YAMAA-01Pembrolizumab1200200
YAMAA-01Pembrolizumab2150200
YAMAA-01Pembrolizumab3150150
YAMAA-01Pemetrexed4500500
YAMAA-01Pembrolizumab1200200

input/subject_treatment.csv

Edit
3 rows
input/subject_treatment.csv
STUDYIDUSUBJIDEXTRTEXDOSU
YAMAA-01Pembrolizumabmg
YAMAA-01Pemetrexedmg/m2
YAMAA-01Pembrolizumabmg

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
ADEXSTUDYIDStudy IdentifiercharacterCopy value from TRT.STUDYID.Predecessor
ADEXUSUBJIDUnique Subject IdentifiercharacterCopy value from TRT.USUBJID.Predecessor
ADEXEXTRTName of TreatmentcharacterCopy value from TRT.EXTRT.Predecessor
ADEXEXDOSUDose UnitscharacterCopy value from TRT.EXDOSU.Predecessor
ADEXDOSECUMCumulative DosenumericAggregate SUM(EX.EXDOSE) over records matching on the shared output keys.Derived
ADEXRDIRelative Dose IntensitynumericAggregate 100 * SUM(EX.EXDOSE) / EX.EXPLDOS over records matching on STUDYID, USUBJID and EXTRT.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