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: build the analysis start date (ASTDT) for each
collected adverse event (AE), completing a start recorded without
a day.
Input: collected adverse events carrying the reported start
(AESTDTC), which is sometimes a year and month with no day and
sometimes a year with no month.
Variables:
ASTDTwould contain the collected start, kept as collected when it is a complete date and otherwise completed with daymid(and month6for a year alone).
The day value mid is neither a day number nor one of the two
positions every month has, first and last, so the run is
rejected before any data is read and no artifact is accepted.
How to fix
Decide where in the month the analysis date should fall, then name a position a calendar fixes or name the day itself. To place a start recorded as a year and month on the first of that month:
date_impute:
source: AE.AESTDTC
month: 6
day: first
A value such as 2023-06 then becomes 2023-06-01. Writing day: last
instead gives 2023-06-30, and writing day: 15 names the fifteenth of the
collected month directly.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- value_not_permitted
- requirement
- REQ-0609
expected/error.yaml
phase: validation
condition: value_not_permitted
spec_paths:
- columns.ASTDT.derivation.date_impute.day
requirement: REQ-0609
context:
value: mid
permitted: [first, last]
Inputs
Under review1 source fileinput/ae.csv
Edit3 rows| STUDYID | USUBJID | AESEQ | AETERM | AESTDTC |
|---|---|---|---|---|
| YAMAA-01 | 1 | Headache | 2023-06 | |
| YAMAA-01 | 2 | Pyrexia | 2023-06-14 | |
| YAMAA-01 | 1 | Nausea | 2023 |
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 | ASTDT | Analysis Start Date | numeric | ISO 8601 | Impute incomplete date from AE.AESTDTC, defaulting month=6, day=mid; missing or invalid input yields null. | 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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