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: complete the analysis start date (ASTDT) of each
adverse event (AE) from the collected start (AESTDTC), supplying
a month and a day wherever the collected text does not already
carry them.
Input: collected event records carrying the reported term
(AETERM) and the collected start (AESTDTC), at year,
year-and-month, and full-date precision.
Variables:
ASTDTwould be the analysis start date completed fromAESTDTC: the 15th of the month for a year-and-month start, the 15th of the stated month for a year-only start, and the collected date unchanged when it is already complete. The policy accepts year-only starts, so it needs a month to give them, but the specification names none. The run is rejected before any data is read and no artifact is accepted.
How to fix
Write the month the policy can use. Because this benchmark describes mid-month imputation, June is the consistent correction:
date_impute:
source: AE.AESTDTC
month: 6
day: 15
minimum_source_precision: year
A year-and-month value such as 2023-06 then becomes 2023-06-15, and a
year-only value such as 2023 becomes 2023-06-15.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- month_required
- requirement
- REQ-0592
expected/error.yaml
phase: validation
condition: month_required
spec_paths:
- columns.ASTDT.derivation.date_impute.month
requirement: REQ-0592
context:
minimum_source_precision: year
Inputs
Under review1 source fileinput/ae.csv
Edit3 rows| STUDYID | USUBJID | AESEQ | AETERM | AESTDTC |
|---|---|---|---|---|
| YAMAA-01 | 1 | Nausea | 2023 | |
| YAMAA-01 | 2 | Headache | 2023-06 | |
| YAMAA-01 | 3 | Fatigue | 2023-06-14 |
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 | AESTDTC | Start Date/Time of Adverse Event | character | Copy value from AE.AESTDTC. | Predecessor | ||
| ADAE | ASTDT | Analysis Start Date | numeric | ISO 8601 | Impute incomplete date from AE.AESTDTC, defaulting day=15; 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 |
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Comments
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