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: carry the age (AGE) for each subject the extract holds.
Input: EDC output in long form, one row per collected item; each subject has a sex row and an age row.
Variables:
- AGE would be the age in whole years as collected. The collected
rows it reads are also chosen by subject, under the name
USUBJID, which those rows do not carry: they hold the subject asSubjectKey. The run is therefore rejected before any data is read, and no artifact is accepted.
How to fix
Decide what distinguishes the collected rows the age comes from, then say it in the words the records use. The collected rows carry the item they answer and the subject they belong to under the extract's own names:
- name: AGE
type: int
label: Age
derivation:
source:
filter: ODM.ItemOID = 'IT.DM.AGE'
variable: ODM.Value
The subject needs no mention: each record is built for one subject and reads only the rows that subject was collected under.
When the intent was to leave some subjects without an age, state that as a rule over the built record rather than over the collected rows, for example by mapping a collected exclusion flag.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- unknown_field
- requirement
- REQ-0132
expected/error.yaml
phase: validation
condition: unknown_field
spec_paths:
- columns.AGE.derivation.source.filter
requirement: REQ-0132
context:
identifier: USUBJID
dataset: ODM
Inputs
Under review1 source fileinput/odm.csv
Edit4 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 | 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 | ||||
| AGE | Age | Num | Collected | Copy value from ODM.Value where ODM.ItemOID = 'IT.DM.AGE' AND USUBJID <> '002'. | SDTM | 4 |
| 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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