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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: carry the age (AGE) for each subject the extract holds.
Input: EDC output in long form, one row per collected item; each subject has a sex row and an age row.
Variables:
- AGE would be the age in whole years as collected. The collected
rows it reads are also chosen by subject, under the name
USUBJID, which those rows do not carry: they hold the subject asSubjectKey. The run is therefore rejected before any data is read, and no artifact is accepted.
How to fix
Decide what distinguishes the collected rows the age comes from, then say it in the words the records use. The collected rows carry the item they answer and the subject they belong to under the extract's own names:
- name: AGE
type: int
label: Age
derivation:
source:
filter: ODM.ItemOID = 'IT.DM.AGE'
variable: ODM.Value
The subject needs no mention: each record is built for one subject and reads only the rows that subject was collected under.
When the intent was to leave some subjects without an age, state that as a rule over the built record rather than over the collected rows, for example by mapping a collected exclusion flag.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- unknown_field
- rule
- LOOKUP-8
expected/error.yaml
phase: validation
condition: unknown_field
spec_paths:
- columns.AGE.derivation.source.filter
rule: LOOKUP-8
context:
identifier: USUBJID
dataset: ODM
Inputs
Under review1 source fileinput/odm.csv
Edit4 rows| StudyOID | MetaDataVersionOID | SubjectKey | StudyEventOID | StudyEventRepeatKey | ItemGroupOID | ItemGroupRepeatKey | ItemOID | Value |
|---|---|---|---|---|---|---|---|---|
| STUDY01 | MDV.1 | 001 | SCREENING | 1 | IG.DM | 1 | IT.DM.SEX | Male |
| STUDY01 | MDV.1 | 001 | SCREENING | 1 | IG.DM | 1 | IT.DM.AGE | 34 |
| STUDY01 | MDV.1 | 002 | SCREENING | 1 | IG.DM | 1 | IT.DM.SEX | Female |
| STUDY01 | MDV.1 | 002 | SCREENING | 1 | IG.DM | 1 | IT.DM.AGE | 28 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| DOMAIN | Domain Abbreviation | Char | Assigned | Set constant value "DM". | SDTM | 1 | ||||
| STUDYID | Study Identifier | Char | Collected | Copy value from ODM.StudyOID. | SDTM | 2 | ||||
| USUBJID | Unique Subject Identifier | Char | Collected | Copy value from ODM.SubjectKey. | SDTM | 3 | ||||
| AGE | Age | Num | Collected | Copy value from ODM.Value where ODM.ItemOID = 'IT.DM.AGE' AND USUBJID <> '002'. | SDTM | 4 |
| 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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