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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: flag adverse events (AE) whose onset falls inside a 30-day
post-treatment review window in REVIEWFL.
Input: collected adverse events with onset date (AESTDTC) and the
end of treatment (TRTEDT).
Variables:
REVIEWFLwould containYwhen the onset is no more than 30 days after treatment ended, otherwiseN.
Note: the condition adds 30 to the treatment end date, but
arithmetic takes numbers and TRTEDT is a date, so the run is rejected
before any data is read and no artifact is accepted.
How to fix
Carry the day count in its own column and compare the named value:
- name: WINDOWDY
type: int
label: Days from Treatment End to Onset
derivation:
diff:
type: date
start: TRTEDT
end: ASTDT
unit: day
- name: REVIEWFL
type: str
label: Protocol Review Flag
derivation:
flag:
condition: "WINDOWDY <= 30"
false_value: "N"
missing: "N"
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- incompatible_input_type
- rule
- FORMULA-12
expected/error.yaml
phase: validation
condition: incompatible_input_type
spec_paths:
- columns.REVIEWFL.derivation.flag.condition
rule: FORMULA-12
context:
expr: "ASTDT <= TRTEDT + 30"
source: TRTEDT
expected: numeric
actual: date
Inputs
Under review1 source fileinput/ae.csv
Edit2 rows| STUDYID | USUBJID | AESEQ | AETERM | AESTDTC | TRTEDT |
|---|---|---|---|---|---|
| PILOT7 | 1 | Headache | 2025-03-10 | 2025-03-01 | |
| PILOT7 | 2 | Nausea | 2025-04-15 | 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 | TRTEDT | Date of Last Exposure to Treatment | numeric | ISO 8601 | Copy value from AE.TRTEDT. | Predecessor | |
| ADAE | REVIEWFL | Protocol Review Flag | character | "Y" when ASTDT <= TRTEDT + 30; "N" otherwise; "N" when the condition is unknown. | 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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