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: derive TRT01A, the actual treatment for the first
period, as a single subject-level record from exposure records.
Input: demographics records with exposure records carrying
administered treatment (EXTRT), start date (EXSTDTC), and
sequence number (EXSEQ).
Variables:
TRT01Awould be the treatment from the chosen exposure record.
Note: the administrations are placed in start-date and sequence-number order with no statement of which end supplies the treatment, so a subject whose administrations disagree has more than one possible answer. The run is rejected before any data is read and no artifact is accepted.
How to fix
State which end of the order supplies the treatment alongside the order itself. For the earliest treatment:
intermediates:
- id: DOSING
dataset: EX
order_by: [EX.EXSTDTC, EX.EXSEQ]
keep: first
Use the latest end only when the intended result is the latest treatment.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- unpaired_fields
- requirement
- REQ-0119
expected/error.yaml
phase: validation
condition: unpaired_fields
spec_paths:
- intermediates[0]
requirement: REQ-0119
context:
intermediate: DOSING
declared:
- order_by
missing:
- keep
Inputs
Under review2 source filesUnexpected 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 | TRT01A | Actual Treatment for Period 01 | character | Take EXTRT from the EX record matching on the shared output keys, ordered by EX.EXSTDTC then EX.EXSEQ, and a row with no match is an error. | Derived |
| 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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