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: carry each adverse event (AE) term into AETERM and its
start moment into ASTDTM.
Input: collected adverse event records carrying term (AETERM)
and start text (AESTDTC).
Variables:
ASTDTMwould contain the start moment copied fromAESTDTC, a site-clock reading with no clock offset. A start that carries an offset, such as+02:00, is not the same kind of value, so the run stops while converting values and no artifact is accepted.
How to fix
Decide whether the study collects an offset at all. If the site clock is what was recorded, correct the collected value so every start reads the same way:
YAMAA-01,YAMAA-01-101,2,HEADACHE,2025-03-04T09:00:00
If the offset is real data, collect it as a field of its own and keep
AESTDTC to the site clock. ASTDTM then holds the moment and a second text
column holds the offset, where a later analysis can read it.
To inspect the collected characters without failing, carry them in an
intermediate text column that is not ASTDTM:
- name: AESTDTC_RAW
type: str
label: Collected Start Text
derivation: AE.AESTDTC
The text keeps the collected characters but does not order
chronologically across offsets, and it is not an analysis variable:
ASTDTM stays a moment.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- convert
- condition
- conversion_failed
- requirement
- REQ-0601
expected/error.yaml
phase: convert
condition: conversion_failed
spec_paths:
- columns.ASTDTM
requirement: REQ-0601
context:
from: str
to: datetime
value: "2025-03-04T09:00:00+02:00"
keys:
- STUDYID: YAMAA-01
USUBJID: YAMAA-01-101
AESEQ: 2
Inputs
Under review1 source fileinput/ae.csv
Edit2 rows| STUDYID | USUBJID | AESEQ | AETERM | AESTDTC |
|---|---|---|---|---|
| YAMAA-01 | 1 | NAUSEA | 2025-03-04T09:00:00 | |
| YAMAA-01 | 2 | HEADACHE | 2025-03-04T09:00:00+02:00 |
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 | AESEQ | 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 | ASTDTM | Analysis Start Date/Time | 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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