yamaa 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
EditUnder reviewWhat this benchmark meansREADME.mdGoal: arrange adverse event (AE) records so each subject's
events read together, newest onset first, carrying the reported
term (AETERM) and onset date (ASTDT).
Input: collected adverse event records carrying the reported
term (AETERM) and the onset date (AESTDTC).
Variables:
AETERMwould be the reported term for the event, carried over from the collected records.ASTDTwould be the date the event began, carried over from the collected onset date.
Note: the records are to be presented by subject ascending, then by onset date with the most recent first, then by subject descending again. The subject takes two places with opposite directions, and the second can never change the order the first already fixed, so the intended order is unclear. The run is rejected before any data is read and no artifact is accepted.
How to fix
Decide which position the subject holds and state it once. Grouping a subject's events together while reading the newest first is the subject ascending first and the date descending:
output:
path: adae.csv
columns: [STUDYID, USUBJID, ASEQ, AETERM, ASTDT]
order_by:
- USUBJID
- variable: ASTDT
direction: desc
Presenting the subjects in reverse instead means declaring the subject descending once, in the first position, rather than adding a second entry for it.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- duplicate_order_term
- requirement
- REQ-0224
expected/error.yaml
phase: validation
condition: duplicate_order_term
spec_paths:
- output.order_by[2]
requirement: REQ-0224
context:
column: USUBJID
Inputs
Under review1 source fileinput/ae.csv
Edit3 rows| STUDYID | USUBJID | AESEQ | AETERM | AESTDTC |
|---|---|---|---|---|
| PILOT7 | 1 | Nausea | 2025-03-10 | |
| PILOT7 | 2 | Rash | 2025-03-12 | |
| PILOT7 | 1 | Headache | 2025-04-02 |
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 |
|---|---|---|---|---|---|---|---|
| ADAE | STUDYID | Study Identifier | character | Copy value from AE.STUDYID. | Predecessor | ||
| ADAE | USUBJID | Unique Subject Identifier | character | Copy value from AE.USUBJID. | Predecessor | ||
| ADAE | ASEQ | Analysis Sequence Number | numeric | Copy value from AE.AESEQ. | Predecessor | ||
| ADAE | AETERM | Reported Term for the Adverse Event | character | Copy value from AE.AETERM. | Predecessor | ||
| ADAE | ASTDT | Analysis Start Date | numeric | ISO 8601 | Copy value from AE.AESTDTC. | 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 |
Comments
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