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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: mark the baseline record of each subject and parameter
with ABLFL and repeat its value with BASE.
Input: collected laboratory results with test code, collection
date, and numeric result (LBTESTCD, LBDTC, LBSTRESN), plus
subject treatment start dates from ADSL (TRTSDT).
Variables:
ADTwould contain the collection date, taken fromLBDTC.TRTSDTwould contain the subject's treatment start date, taken from ADSLTRTSDT.AVALwould contain the analysis value, taken fromLBSTRESN.ABLFLwould beYon the baseline record for the subject and parameter: the latest result on or before treatment start, and blank on every other record.BASEwould contain the baseline record'sAVALon every record for the subject and parameter; missing when no result falls on or before treatment start.
Note: results sharing one collection date can tie for latest, and either candidate gives the parameter a different baseline. The run fails and no dataset is accepted.
How to fix
Decide which of the two draws is the baseline before choosing how to state it. Two results drawn on the same day are usually a sample and its repeat, and the source data system should carry the result the study reports, or a collection time that separates the draws. Correcting it there leaves the rule saying what it means: the latest result on or before treatment start.
When both draws are reportable and the study states a tie-break, declare it. The baseline is then the last of the same-day results in that order:
- name: ABLFL
type: str
derivation:
baseline_flag:
window:
group_by: [STUDYID, USUBJID, PARAMCD]
order_by: [ADT, LBSEQ]
date: ADT
reference: TRTSDT
source: AVAL
Order by the term the study names, such as a collection time; the sequence number above stands in for it and is not itself a clinical rule. Results still equal on every declared term fail the same way. Do not average the two results into one baseline value, which reports a measurement nobody took.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- derivation
- condition
- ambiguous_baseline
- rule
- WINDOW-9
expected/error.yaml
phase: derivation
condition: ambiguous_baseline
spec_paths:
- columns.ABLFL.derivation.baseline_flag
rule: WINDOW-9
context:
date: "2025-01-06"
match_count: 2
keys:
- STUDYID: CATH
USUBJID: CATH-UCSD-0001
PARAMCD: ALT
Inputs
Under review2 source filesUnexpected 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 |
|---|---|---|---|---|---|---|---|
| ADLB | STUDYID | Study Identifier | character | Copy value from LB.STUDYID. | Predecessor | ||
| ADLB | USUBJID | Unique Subject Identifier | character | Copy value from LB.USUBJID. | Predecessor | ||
| ADLB | PARAMCD | Parameter Code | character | Copy value from LB.LBTESTCD. | Predecessor | ||
| ADLB | LBSEQ | Sequence Number | numeric | Copy value from LB.LBSEQ. | Predecessor | ||
| ADLB | ADT | Analysis Date | numeric | ISO 8601 | Copy value from LB.LBDTC. | Predecessor | |
| ADLB | TRTSDT | Date of First Exposure to Treatment | numeric | ISO 8601 | Copy value from ADSL.TRTSDT. | Predecessor | |
| ADLB | AVAL | Analysis Value | numeric | Copy value from LB.LBSTRESN. | Predecessor | ||
| ADLB | ABLFL | Baseline Record Flag | character | "Y" for the last record with ADT on or before TRTSDT and a non-missing AVAL within each group of STUDYID, USUBJID, PARAMCD, ordered by ADT; blank otherwise. | Derived | ||
| ADLB | BASE | Baseline Value | numeric | Aggregate ONLY(AVAL) over records grouped by STUDYID, USUBJID, PARAMCD, matching on the shared output keys, where ABLFL = 'Y'. | 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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