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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: carry over the analysis value (AVAL) and the baseline
record flag (ABLFL) for each laboratory record.
Input: pre-derived laboratory records carrying study, subject,
and parameter identifiers, the analysis date (ADT), the analysis
value (AVAL), and the baseline record flag (ABLFL). One subject
carries two Y flags for a parameter; another subject carries none.
Variables:
ABLFLis the input baseline flag:Yon the record that serves as the baseline for the subject and parameter, blank on every other record.
Note: each subject and parameter must have exactly one record flagged
Y; a combination with none is rejected as well. Two flagged records leave
the change from baseline undefined, and neither record can be preferred
without inventing a rule the study did not state. The run is rejected and no
artifact is accepted. The expected output records the completed rows
presented to that check.
How to fix
Correct the flag in the incoming records so that one record carries it, choosing the record the study's baseline definition selects, ordinarily the latest result on or before the first exposure. When the flag should be derived here instead of trusted from the input, derive it and let a tie be reported where it arises:
- name: ABLFL
type: str
label: Baseline Record Flag
derivation:
baseline_flag:
window:
group_by: [STUDYID, USUBJID, PARAMCD]
date: ADT
reference: TRTSDT
source: AVAL
Do not widen the count to accept two records; a second baseline is a defect in the data rather than a policy the analysis can adopt.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- verification
- condition
- row_count_failed
- rule
- CHECK-13
expected/error.yaml
phase: verification
condition: row_count_failed
spec_paths:
- verifications[0].row_count
rule: CHECK-13
context:
verification_id: one-baseline-record-per-subject-and-parameter
failure_count: 2
keys:
- STUDYID: YAMAA-01
USUBJID: YAMAA-01-101
PARAMCD: ALT
- STUDYID: YAMAA-01
USUBJID: YAMAA-01-103
PARAMCD: ALT
counts:
- 2
- 0
Inputs
Under review1 source fileinput/adlb_raw.csv
Edit7 rows| STUDYID | USUBJID | PARAMCD | ADT | AVAL | ABLFL |
|---|---|---|---|---|---|
| YAMAA-01 | ALT | 2025-01-01 | 10 | Y | |
| YAMAA-01 | ALT | 2025-01-02 | 12 | Y | |
| YAMAA-01 | ALT | 2025-01-08 | 15 | — | |
| YAMAA-01 | ALT | 2025-01-01 | 8 | Y | |
| YAMAA-01 | ALT | 2025-01-08 | 12 | — | |
| YAMAA-01 | ALT | 2025-01-01 | 9 | — | |
| YAMAA-01 | ALT | 2025-01-08 | 11 | — |
Unexpected Output
Under review7 rows presented to the failing check - not an accepted artifactexpected/adlb.csv
Edit7 rows| STUDYID | USUBJID | PARAMCD | ADT | AVAL | ABLFL |
|---|---|---|---|---|---|
| YAMAA-01 | ALT | 2025-01-01 | 10 | Y | |
| YAMAA-01 | ALT | 2025-01-02 | 12 | Y | |
| YAMAA-01 | ALT | 2025-01-08 | 15 | — | |
| YAMAA-01 | ALT | 2025-01-01 | 8 | Y | |
| YAMAA-01 | ALT | 2025-01-08 | 12 | — | |
| YAMAA-01 | ALT | 2025-01-01 | 9 | — | |
| YAMAA-01 | ALT | 2025-01-08 | 11 | — |
Human review and assessment
| Dataset Name | Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Computational Method | Origin |
|---|---|---|---|---|---|---|---|
| ADLB | STUDYID | Study Identifier | character | Copy value from ADLB_RAW.STUDYID. | Predecessor | ||
| ADLB | USUBJID | Unique Subject Identifier | character | Copy value from ADLB_RAW.USUBJID. | Predecessor | ||
| ADLB | PARAMCD | Parameter Code | character | Copy value from ADLB_RAW.PARAMCD. | Predecessor | ||
| ADLB | ADT | Analysis Date | numeric | ISO 8601 | Copy value from ADLB_RAW.ADT. | Predecessor | |
| ADLB | AVAL | Analysis Value | numeric | Copy value from ADLB_RAW.AVAL. | Predecessor | ||
| ADLB | ABLFL | Baseline Record Flag | character | Y | Copy value from ADLB_RAW.ABLFL. | Predecessor |
| Variable | Permitted values |
|---|---|
| ABLFL | Y |
| 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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