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 one record per subject carrying RFSTD, DTHDTM,
and DTHDY.
Input: collected demographics rows carrying the treatment-start
date (RFSTDT) and the collected moment of death (DTHDTC).
Variables:
RFSTDwould hold the treatment-start date copied from the collected date.DTHDTMwould hold the moment of death, time of day included, copied from the collected moment, and would be blank when no death is recorded.DTHDYwould hold the study day of death, with the treatment-start date as day 1 and no day zero, and would be blank when no death is recorded.
A study day counts calendar dates, and a moment is not one: widening the moment into a date would choose silently between two adjacent days, so no reader may do so. The request is rejected before any data is read, and no artifact is accepted.
How to fix
Decide which calendar day the study reports, then state it as a date. When only the moment is collected, take its calendar date first and count the study day from that date:
- name: DTHDT
type: date
label: Date of Death
derivation:
to_date:
source: DTHDTM
- name: DTHDY
type: int
label: Study Day of Death
derivation:
study_day:
date: DTHDT
reference: RFSTD
When the time of day carries meaning, a day count is the wrong result; keep the moment instead of forcing it into one.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- incompatible_input_type
- requirement
- REQ-0606
expected/error.yaml
phase: validation
condition: incompatible_input_type
spec_paths:
- columns.DTHDY.derivation.study_day.date
requirement: REQ-0606
context:
source: DTHDTM
expected: date
actual: datetime
Inputs
Under review1 source fileinput/dm.csv
Edit2 rows| STUDYID | USUBJID | RFSTDT | DTHDTC |
|---|---|---|---|
| PILOT7 | 2023-01-02 | 2023-05-14T18:30:00 | |
| PILOT7 | 2023-02-10 | — |
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 |
|---|---|---|---|---|---|---|---|
| ADSL | STUDYID | Study Identifier | character | Copy value from DM.STUDYID. | Predecessor | ||
| ADSL | USUBJID | Unique Subject Identifier | character | Copy value from DM.USUBJID. | Predecessor | ||
| ADSL | RFSTD | Reference Start Date | numeric | ISO 8601 | Copy value from DM.RFSTDT. | Predecessor | |
| ADSL | DTHDTM | Moment of Death | numeric | ISO 8601 | Copy value from DM.DTHDTC. | Predecessor | |
| ADSL | DTHDY | Study Day of Death | numeric | CDISC study day of DTHDTM against RFSTD as day 1; there is no day zero. | 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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