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 subject randomization date RANDDT from
demographics into the subject-level analysis file.
Input: a subject-level demographics file holding the study and
subject identifiers with RANDDT, produced from an Operational
Data Model (ODM) extract.
Variables:
RANDDTwould be the subject's randomization date, taken fromRANDDTin the demographics file.
Note: the date's value kind is already fixed where the demographics file is produced. Stating it again beside the source would leave two authorities for the same field even when they agree, so the run is rejected before any data is read and no artifact is accepted.
How to fix
Keep the producing DM specification as the single type authority and remove
the inline types entry:
input:
DM:
path: input/dm.csv
schema: input/dm.schema.yaml
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- redundant_field_type
- requirement
- REQ-0523
expected/error.yaml
phase: validation
condition: redundant_field_type
spec_paths:
- input.DM.types.RANDDT
requirement: REQ-0523
context:
dataset: DM
field: RANDDT
type: date
Inputs
Under review3 source filesinput/dm.csv
Edit1 row| STUDYID | USUBJID | RANDDT |
|---|---|---|
| YAMAA-01 | 2025-01-12 |
input/dm.schema.yaml
Editschema_version: "1.0"
domain: DM
keys: [STUDYID, USUBJID]
input:
ODM: odm.csv
output:
path: dm.csv
columns: [STUDYID, USUBJID, RANDDT]
columns:
- name: STUDYID
type: str
label: Study Identifier
derivation: ODM.StudyOID
- name: USUBJID
type: str
label: Unique Subject Identifier
derivation: ODM.SubjectKey
- name: RANDDT
type: date
label: Date of Randomization
derivation: ODM.Value
rows:
- id: subject
filter: "ODM.ItemOID = 'IT.DM.RANDDT'"
derivations: {}
input/odm.csv
Edit1 row| StudyOID | MetaDataVersionOID | SubjectKey | StudyEventOID | StudyEventRepeatKey | ItemGroupOID | ItemGroupRepeatKey | ItemOID | Value |
|---|---|---|---|---|---|---|---|---|
| YAMAA-01 | MDV.1 | YAMAA-01-001 | SCREENING | 1 | IG.DM | 1 | IT.DM.RANDDT | 2025-01-12 |
Unexpected Output
Under reviewNo artifact is producedNo fixture files in this directory.
Comments and assessment materials
| Dataset Name | Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Computational Method | Origin |
|---|---|---|---|---|---|---|---|
| ADSL | STUDYID | Study Identifier | character | Copy value from DM.STUDYID. | Predecessor | ||
| ADSL | USUBJID | Unique Subject Identifier | character | Copy value from DM.USUBJID. | Predecessor | ||
| ADSL | RANDDT | Date of Randomization | numeric | ISO 8601 | Copy value from DM.RANDDT. | Predecessor |
| 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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