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.
- 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 planned arm (ARM) and the actual arm (ACTARM) for each subject.
Input: EDC output in long form, one row per collected item.
Variables:
- ARM would be the planned arm as collected;
Unassignedwhen none was collected. - ACTARM would be the actual arm, a copy of the planned arm, but the copy also states which collected rows to choose among. The planned arm is one value by then rather than a set of rows, so the run is rejected before any data is read and no artifact is accepted.
How to fix
Decide whether the actual arm repeats a value the record already carries or reads the collected rows itself. Repeating the planned arm names it and nothing else:
- name: ACTARM
type: str
label: Description of Actual Arm
derivation:
source: ARM
When the actual arm is collected in its own right, read the rows that hold it, exactly as the planned arm does:
- name: ACTARM
type: str
label: Description of Actual Arm
derivation:
first_available:
sources:
- filter: ODM.ItemOID = 'IT.DM.ACTARM'
variable: ODM.Value
missing: Unassigned
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- prohibited_construct
- requirement
- REQ-0148
expected/error.yaml
phase: validation
condition: prohibited_construct
spec_paths:
- columns.ACTARM.derivation.source.filter
requirement: REQ-0148
context:
identifier: ARM
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.
Shaded columns are derived— = missing value
Comments and assessment materials
Not under review
| 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 | ||||
| ARM | Description of Planned Arm | Char | Derived | First non-missing of ODM.Value where ODM.ItemOID = 'IT.DM.ARM'; all missing → "Unassigned". | SDTM | 4 | ||||
| ACTARM | Description of Actual Arm | Char | Derived | Copy value from ARM where ODM.ItemOID = 'IT.DM.ARM'. | 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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Comments
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