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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: write each adverse event's collected start (AESTDTC) as ISO
8601 text from the start year, month and day collected on the form.
Input: collected adverse event records, each identified by study, subject and sequence, carrying the reported term and the start year, month and day as separate text fields; a part that was not collected is empty.
Variables:
AESTDTCwould be the collected start at the precision collected: a full date (2026-03-15), a year and month, or a year alone, stopping before the first part that was not collected. A month written as one digit, such as3, is not an ISO 8601 month, so the run is rejected and no artifact is accepted.
How to fix
Correct the collected data first: an ISO 8601 month is two digits, so
the month the site recorded as 3 is 03 at its source. When the
extract delivers the parts as numbers, read them as integers on the input
instead; an integer part is written with its leading zero:
input:
AE_RAW: {path: input/ae_raw.csv, types: {AESEQ: int, AESTMO: int}}
If a malformed part should leave the start empty rather than stop the
run, declare that outcome explicitly with invalid: null on the dtc
operation, and review the records it empties.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- impute
- condition
- invalid_date_text
- rule
- TIME-19
expected/error.yaml
phase: impute
condition: invalid_date_text
spec_paths:
- columns.AESTDTC.derivation.dtc
rule: TIME-19
context:
part: month
source: AE_RAW.AESTMO
value: "3"
keys:
- STUDYID: YAMAA-01
USUBJID: YAMAA-01-001
AESEQ: 2
Inputs
Under review1 source fileinput/ae_raw.csv
Edit3 rows| STUDYID | USUBJID | AESEQ | AETERM | AESTYR | AESTMO | AESTDY |
|---|---|---|---|---|---|---|
| YAMAA-01 | 1 | Headache | 2026 | 03 | 15 | |
| YAMAA-01 | 2 | Nausea | 2026 | 3 | — | |
| YAMAA-01 | 1 | Rash | 2026 | — | — |
Unexpected Output
Under reviewNo artifact is producedNo fixture files in this directory.
Human review and assessment
| Variable Name | Variable Label | Type | Length | Controlled Terms or Format | Origin | Core | Conversion Definition | Variable Type | Variable Order | Comments for Define |
|---|---|---|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | Char | Collected | Copy value from AE_RAW.STUDYID. | SDTM | 1 | ||||
| USUBJID | Unique Subject Identifier | Char | Collected | Copy value from AE_RAW.USUBJID. | SDTM | 2 | ||||
| AESEQ | Sequence Number | Num | Collected | Copy value from AE_RAW.AESEQ. | SDTM | 3 | ||||
| AETERM | Reported Term for the Adverse Event | Char | Collected | Copy value from AE_RAW.AETERM. | SDTM | 4 | ||||
| AESTDTC | Start Date/Time of Adverse Event | Char | Derived | Write the collected year AE_RAW.AESTYR, month AE_RAW.AESTMO, day AE_RAW.AESTDY as ISO 8601 date text, stopping before the first blank part; blank when the year is blank; a part that is not its digits is an error. | SDTM | 5 |
| 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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