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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: submit the laboratory results (LBTESTCD, LBTEST, LBORRES),
describing the results the site tests apart from all the others.
Input: laboratory results, one row per test per subject.
Variables:
LBTESTCDandLBTESTare the test's code and name.LBORRESis the result as reported, in the reporting laboratory's units.
Note: the central laboratory's results are described as the tests other than the site's two, and the site's results as the tests other than the central laboratory's two. A test that is none of the four, or a result without a test code, would then fit both descriptions, so they are rejected before any data is read.
How to fix
Name the site's tests in its description, so that the central laboratory's description, which excludes them, takes every other test:
- id: SITE
where: {LBTESTCD: [HCG, PH]}
Exclude a list of values in one description only; two exclusions on one column always share the rows that hold neither list, a missing value among them.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- value_level_overlap
- rule
- SUB-12
expected/error.yaml
phase: validation
condition: value_level_overlap
spec_paths:
- columns.LBORRES.submission.value_level.CENTRAL.where
- columns.LBORRES.submission.value_level.SITE.where
rule: SUB-12
context:
column: LBORRES
entries:
- CENTRAL
- SITE
Inputs
Under review1 source fileinput/lab.csv
Edit4 rows| STUDYID | USUBJID | LBTESTCD | LBTEST | LBORRES |
|---|---|---|---|---|
| LAB02 | ALT | Alanine Aminotransferase | 24 | |
| LAB02 | CREAT | Creatinine | 0.9 | |
| LAB02 | HCG | Choriogonadotropin Beta | NEGATIVE | |
| LAB02 | PH | pH | 6.0 |
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 | 2 | Assigned | Req | Set constant value "LB". | SDTM | 1 | ||
| STUDYID | Study Identifier | Char | 5 | Protocol | Req | Copy value from LAB.STUDYID. | SDTM | 2 | ||
| USUBJID | Unique Subject Identifier | Char | 9 | Assigned | Req | Copy value from LAB.USUBJID. | SDTM | 3 | ||
| LBTESTCD | Lab Test or Examination Short Name | Char | 5 | Protocol | Req | Copy value from LAB.LBTESTCD. | SDTM | 4 | ||
| LBTEST | Lab Test or Examination Name | Char | 24 | Protocol | Req | Copy value from LAB.LBTEST. | SDTM | 5 | ||
| LBORRES | Result or Finding in Original Units | Char | 8 | Collected, Collected | Exp | Copy value from LAB.LBORRES. | SDTM | 6 |
| 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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