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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: derive each adverse event's analysis start date (ASTDT) from
the collected start, completing a partial start to the earliest date it
allows.
Input: adverse event records, each identified by study, subject and
sequence, carrying the collected start (AESTDTC) as ISO 8601 text: a
full date, a date whose month is unknown written with a hyphen in its
place (2025---15), or a period between two dates
(2025-03-01/2025-03-10).
Variables:
ASTDTwould be the start date: a full date stands, and a start whose month is unknown is completed from its year alone, to 1 January, whatever day was collected. A start recorded as a period between two dates names no single date to complete, so the run is rejected and no artifact is accepted.
How to fix
Decide clinically which date a period of uncertainty stands for. For the earliest possible onset, take the period's first date into its own column before completing it:
- name: ASTDTC
type: str
derivation:
str_extract:
source: AE.AESTDTC
pattern: "^[^/]+"
and complete ASTDTC instead of AE.AESTDTC. If an onset recorded as a
period should have no analysis date, declare that outcome with
invalid: null on impute; it then answers every start that names no
single date.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- impute
- condition
- interval_or_duration_text
- rule
- TIME-13
expected/error.yaml
phase: impute
condition: interval_or_duration_text
spec_paths:
- columns.ASTDT.derivation.impute
rule: TIME-13
context:
source: AE.AESTDTC
value: 2025-03-01/2025-03-10
keys:
- STUDYID: YAMAA-01
USUBJID: YAMAA-01-101
AESEQ: 3
Inputs
Under review1 source fileinput/ae.csv
Edit3 rows| STUDYID | USUBJID | AESEQ | AETERM | AESTDTC |
|---|---|---|---|---|
| YAMAA-01 | 1 | Headache | 2025-03-04 | |
| YAMAA-01 | 2 | Rash | 2025---15 | |
| YAMAA-01 | 3 | Nausea | 2025-03-01/2025-03-10 |
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 | Impute incomplete date from AE.AESTDTC, defaulting month=1, day=1; invalid text is an error. | 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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