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: 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) orF(Female), andUwhen 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
Editthe run is rejected; no artifact is acceptedexpected/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 review1 source fileinput/odm.csv
Edit5 rows| StudyOID | MetaDataVersionOID | SubjectKey | StudyEventOID | StudyEventRepeatKey | ItemGroupOID | ItemGroupRepeatKey | ItemOID | Value |
|---|---|---|---|---|---|---|---|---|
| STUDY01 | MDV.1 | 001 | SCREENING | 1 | IG.DM | 1 | IT.DM.SEX | Male |
| STUDY01 | MDV.1 | 001 | SCREENING | 1 | IG.DM | 1 | IT.DM.AGE | 34 |
| STUDY01 | MDV.1 | 002 | SCREENING | 1 | IG.DM | 1 | IT.DM.SEX | Female |
| STUDY01 | MDV.1 | 002 | SCREENING | 2 | IG.DM | 1 | IT.DM.SEX | Male |
| STUDY01 | MDV.1 | 002 | SCREENING | 1 | IG.DM | 1 | IT.DM.AGE | 28 |
Unexpected Output
Under reviewNo artifact is producedNo fixture files in this directory.
Comments and assessment materials
| Variable Name | Variable Label | Type | Length | Controlled Terms or Format | Origin | Core | Conversion Definition | Variable Type | Variable Order | Comments for Define |
|---|---|---|---|---|---|---|---|---|---|---|
| DOMAIN | Domain Abbreviation | Char | Assigned | Set constant value "DM". | SDTM | 1 | ||||
| STUDYID | Study Identifier | Char | Collected | Copy value from ODM.StudyOID. | SDTM | 2 | ||||
| USUBJID | Unique Subject Identifier | Char | Collected | Copy value from ODM.SubjectKey. | SDTM | 3 | ||||
| SEX | Sex | Char | Collected | Recode ODM.Value where ODM.ItemOID = 'IT.DM.SEX': "Male" → "M", "Female" → "F"; missing values → "U"; unlisted values are errors. | SDTM | 4 | ||||
| AGE | Age | Num | Collected | Copy value from ODM.Value where ODM.ItemOID = 'IT.DM.AGE'. | SDTM | 5 |
| 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 |
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