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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: carry on each subject-level record MRGM, the geometric mean of
the subject's metabolite-to-parent ratios of maximum concentration across
periods.
Input: demographics with one record per subject, and the pharmacokinetic parameters with one metabolite ratio per subject and period, one of them zero because the metabolite concentration was below the limit of quantification.
Variables:
MRGMwould be the exponential of the mean of the natural logarithms of the subject's ratios. A ratio of zero has no logarithm, so no geometric mean exists for that subject, and the run fails while the values are computed and no artifact is accepted.
How to fix
Decide what a ratio of zero means for the analysis. The usual geometric mean is taken over the ratios above zero, which leaves the zero ratio out:
- name: MRGM
type: float
derivation:
aggregate:
key: [STUDYID, USUBJID]
filter: "PP.PPTESTCD = 'MRCMAX' AND PP.PPSTRESN > 0"
expr: "GEOMEAN(PP.PPSTRESN)"
If the study instead substitutes a value related to the limit of quantification, derive that stated substitute first and take the geometric mean of it. 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.MRGM.derivation.aggregate.expr
rule: FORMULA-15
context:
expr: "GEOMEAN(PP.PPSTRESN)"
keys:
- STUDYID: YAMAA-01
USUBJID: YAMAA-01-S02
Inputs
Under review2 source filesinput/dm.csv
Edit2 rows| STUDYID | USUBJID |
|---|---|
| YAMAA-01 | |
| YAMAA-01 |
input/pp.csv
Edit4 rows| STUDYID | DOMAIN | USUBJID | PPSEQ | PPTESTCD | PPTEST | PPSTRESN | PPSTRESU | VISITNUM | VISIT |
|---|---|---|---|---|---|---|---|---|---|
| YAMAA-01 | PP | 1 | MRCMAX | Metabolite Ratio Cmax | 0.4 | RATIO | 1 | PERIOD 1 | |
| YAMAA-01 | PP | 2 | MRCMAX | Metabolite Ratio Cmax | 0.5 | RATIO | 2 | PERIOD 2 | |
| YAMAA-01 | PP | 1 | MRCMAX | Metabolite Ratio Cmax | 0.6 | RATIO | 1 | PERIOD 1 | |
| YAMAA-01 | PP | 2 | MRCMAX | Metabolite Ratio Cmax | 0 | RATIO | 2 | PERIOD 2 |
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 |
|---|---|---|---|---|---|---|---|
| ADSL | STUDYID | Study Identifier | character | Copy value from DM.STUDYID. | Predecessor | ||
| ADSL | USUBJID | Unique Subject Identifier | character | Copy value from DM.USUBJID. | Predecessor | ||
| ADSL | MRGM | Geometric Mean Metabolite Ratio Cmax | numeric | Aggregate GEOMEAN(PP.PPSTRESN) over records matching on STUDYID and USUBJID, where PP.PPTESTCD = 'MRCMAX'. | 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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