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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: carry each neutralizing antibody titer into AVAL on the base-10
logarithmic scale, with one record for each subject, parameter and visit.
Input: immunogenicity results with one neutralizing antibody titer per subject and visit and the assay's lower limit of quantitation, one titer reported as zero because no dilution neutralized the virus.
Variables:
PARAMCD:NABLOG10, the base-10 logarithm of the neutralizing antibody titer.AVALwould be the base-10 logarithm of the titer, and blank when the titer is blank. A titer of zero has no logarithm, so the run fails while the values are computed and no artifact is accepted.
How to fix
Decide what a titer below the lower limit of quantitation means for the analysis. A log-scale analysis usually leaves such titers out; choose the records with a filter that keeps the quantified and the blank titers:
filter: "IS.ISSTRESN IS NULL OR IS.ISSTRESN >= IS.ISLLOQ"
If the study instead imputes such titers, for example as half the lower limit, derive that stated value first and take its logarithm. Do not replace zero with an unstated constant.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- derivation
- condition
- ln_of_nonpositive
- rule
- FORMULA-15
expected/error.yaml
phase: derivation
condition: ln_of_nonpositive
spec_paths:
- columns.AVAL.derivation
rule: FORMULA-15
context:
expr: "LOG10(TITER)"
function: LOG10
keys:
- STUDYID: YAMAA-01
USUBJID: YAMAA-01-202
PARAMCD: NABLOG10
AVISIT: DAY 29
Inputs
Under review1 source fileinput/is.csv
Edit4 rows| STUDYID | USUBJID | ISTESTCD | VISIT | ISSTRESN | ISLLOQ |
|---|---|---|---|---|---|
| YAMAA-01 | NABTITER | DAY 29 | 320 | 10 | |
| YAMAA-01 | NABTITER | DAY 29 | 0 | 10 | |
| YAMAA-01 | NABTITER | DAY 29 | — | 10 | |
| YAMAA-01 | NABTITER | DAY 29 | 40 | 10 |
Unexpected 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 |
|---|---|---|---|---|---|---|---|
| ADIS | STUDYID | Study Identifier | character | Copy value from IS.STUDYID. | Predecessor | ||
| ADIS | USUBJID | Unique Subject Identifier | character | Copy value from IS.USUBJID. | Predecessor | ||
| ADIS | PARAMCD | Parameter Code | character | Set constant value "NABLOG10". | Assigned | ||
| ADIS | AVISIT | Analysis Visit | character | Copy value from IS.VISIT. | Predecessor | ||
| ADIS | AVAL | Analysis Value | numeric | Compute LOG10(TITER). | 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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