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 collected adverse event (AE) start text
(AESTDTC) toward ASTDT.
Input: adverse event records, each identified by study,
subject, and sequence, carrying reported term (AETERM) and
start text (AESTDTC).
Variables:
ASTDT: the event start date, which would carry the collected start text (AESTDTC). A start collected to the month only, such as2023-06, names no single day, and choosing the first, the middle, or the last day would record a day nobody collected. Such text cannot be read as a date, so the run fails and no artifact is accepted.
How to fix
Declare how a partial date is completed. For example, to use the earliest date the collected text permits:
derivation:
date_impute:
source: AE.AESTDTC
month: 1
day: 1
A complete source date is retained; 2023-06 becomes 2023-06-01.
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.ASTDT
requirement: REQ-0601
context:
from: str
to: date
value: "2023-06"
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 | 2023-06-14 | |
| YAMAA-01 | 2 | Fatigue | 2023-06 |
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
| 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 | ASTDT | Analysis Start Date | numeric | ISO 8601 | Copy value from AE.AESTDTC. | 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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