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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: one row per adverse event (AE) with its analysis start date
(ASTDT) and the study day of that start (ASTDY).
Input: collected adverse events with the onset date (AESTDTC) and the
subject's first treatment date (TRTSDT).
Variables:
ASTDTis the onset date as collected.TRTSDTis the date of the first exposure to treatment.ASTDYwould be the study day of the onset: the first treatment date is day 1 and the day before it is day -1. A study day is a count of days, and the column meant to hold it holds calendar dates, so the run is rejected before any data is read and no artifact is accepted.
How to fix
Store the study day as an integer, the type every study day has:
- name: ASTDY
type: int
label: Analysis Start Relative Day
derivation:
study_day:
source: ASTDT
reference: TRTSDT
A specification that needs the calendar date of the onset already has it in
ASTDT.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- conversion_failed
- rule
- VALUE-24
expected/error.yaml
phase: validation
condition: conversion_failed
spec_paths:
- columns.ASTDY
rule: VALUE-24
context:
from: int
to: date
Inputs
Under review1 source fileinput/ae.csv
Edit2 rows| STUDYID | USUBJID | AESEQ | AETERM | AESTDTC | TRTSDT |
|---|---|---|---|---|---|
| PILOT7 | 1 | Headache | 2025-03-10 | 2025-03-01 | |
| PILOT7 | 2 | Nausea | 2025-02-27 | 2025-03-01 |
Unexpected Output
Under reviewNo artifact is producedNo fixture files in this directory.
Human review and assessment
| 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. | Predecessor | |
| ADAE | TRTSDT | Date of First Exposure to Treatment | numeric | ISO 8601 | Copy value from AE.TRTSDT. | Predecessor | |
| ADAE | ASTDY | Analysis Start Relative Day | numeric | ISO 8601 | CDISC study day of ASTDT against TRTSDT as day 1; there is no day zero. | Derived |
| Version | Date | Author | Description | Reviewer | Sign-off |
|---|---|---|---|---|---|
| 1.7 | 2026-10-20 | yamaa docs build | Read a specification in the 1.0 surface as its 0.5 counterpart; state that missing values stay missing where a mapping declares no missing handler, and leave out a declared missing answer that restates a handler's default | ||
| 1.6 | 2026-10-17 | yamaa docs build | Describe collected date parts written as ISO 8601 date text and times of day counted in seconds since midnight | ||
| 1.5 | 2026-10-17 | yamaa docs build | Name collected precision in words instead of letter codes; state imputation fallbacks, minimum source precision, bounds ignored outside the collected period, and invalid text with no handler as an error; describe date and datetime shifts, imputation flag codes, and partial text giving no date part | ||
| 1.4 | 2026-10-15 | yamaa docs build | State datetime precision codes through the hour and minute, and complete only the time parts a collected datetime lacks | ||
| 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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