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: build one Demographics (DM) record per subject carrying sex (SEX) and age (AGE).

Input: EDC output in long form, one row per collected item. A visit entered more than once repeats its items under a new visit repeat key (StudyEventRepeatKey), so one question can carry two answers.

Variables:

  • SEX would be the recorded sex coded M (Male) or F (Female), and U when no answer, a blank answer, or any other answer was collected. The same answer entered twice is still one answer, but a subject with two different answers has no single recorded sex and one record cannot carry both, so the run is rejected and no artifact is accepted.
  • AGE: age in whole years as collected; blank when missing.

How to fix

Decide which answer stands for the subject. Two different sexes for one subject is usually a data issue to query and correct at the source, and correcting it there leaves one answer and needs nothing here.

When both entries are legitimate and the later one corrects the earlier, say so: order the answers as they were collected and keep the last, in a working column the coded value then reads.

- name: SEXCOLL
  type: str
  derivation:
    source:
      filter: ODM.ItemOID = 'IT.DM.SEX'
      variable: ODM.Value
      order_by: [ODM.StudyEventRepeatKey]
      keep: last

- name: SEX
  type: str
  derivation:
    mapping:
      source: SEXCOLL
      dict:
        Male: M
        Female: F
      missing: U

When one entry is the record of the visit and the other is a duplicate to be ignored, name the entry the record reports instead, for example with ODM.ItemOID = 'IT.DM.SEX' AND ODM.StudyEventRepeatKey = 1.

Do not widen the keys to keep both answers: a subject whose visit was entered twice is still one demographics record.

Expected failure

Edit
the run is rejected; no artifact is accepted
expected/error.yaml
phase
derivation
condition
multiple_values_per_key
requirement
REQ-0075
expected/error.yaml
phase: derivation
condition: multiple_values_per_key
spec_paths:
  - columns.SEX.derivation.mapping
requirement: REQ-0075
context:
  identifier: ODM.Value
  value_count: 2
  keys:
    - STUDYID: STUDY01
      USUBJID: "002"

Inputs

Under review
1 source file

input/odm.csv

Edit
5 rows
input/odm.csv
StudyOIDMetaDataVersionOIDSubjectKeyStudyEventOIDStudyEventRepeatKeyItemGroupOIDItemGroupRepeatKeyItemOIDValue
STUDY01MDV.1001SCREENING1IG.DM1IT.DM.SEXMale
STUDY01MDV.1001SCREENING1IG.DM1IT.DM.AGE34
STUDY01MDV.1002SCREENING1IG.DM1IT.DM.SEXFemale
STUDY01MDV.1002SCREENING2IG.DM1IT.DM.SEXMale
STUDY01MDV.1002SCREENING1IG.DM1IT.DM.AGE28

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

Variable NameVariable LabelTypeLengthControlled Terms or FormatOriginCoreConversion DefinitionVariable TypeVariable OrderComments for Define
DOMAINDomain AbbreviationCharAssignedSet constant value "DM".SDTM1
STUDYIDStudy IdentifierCharCollectedCopy value from ODM.StudyOID.SDTM2
USUBJIDUnique Subject IdentifierCharCollectedCopy value from ODM.SubjectKey.SDTM3
SEXSexCharCollectedRecode ODM.Value where ODM.ItemOID = 'IT.DM.SEX': "Male" → "M", "Female" → "F"; missing values → "U"; unlisted values are errors.SDTM4
AGEAgeNumCollectedCopy value from ODM.Value where ODM.ItemOID = 'IT.DM.AGE'.SDTM5
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