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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: keep one record per study drug administration, with the dose in
AVAL.
Input: collected exposure records, one per administration, with the
dose given (EXDOSE).
Variables:
EXSEQis the collected sequence number of the administration.AVALwould be the analysis value of the record.
Note: the value of AVAL is stated twice: once as each subject's total
dose over all administrations, and once, for each administration record, as
the dose given on that record. A total is computed from all of a subject's
records, so it cannot be replaced record by record, and the run is rejected
before any data is read; no artifact is accepted.
How to fix
Decide what AVAL holds on an administration record. When it is the dose
given, state only that, in the column itself:
- name: AVAL
type: float
label: Analysis Value
derivation: EX.EXDOSE
When the subject's total dose is needed as well, give it a column of its own, such as a cumulative dose, rather than replacing it record by record.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- duplicate_derivation
- rule
- SPEC-6
expected/error.yaml
phase: validation
condition: duplicate_derivation
spec_paths:
- columns.AVAL.derivation
rule: SPEC-6
context:
column: AVAL
rows: [administration]
not_row_local: aggregate
Inputs
Under review1 source fileinput/ex.csv
Edit3 rows| STUDYID | USUBJID | EXSEQ | EXDOSE |
|---|---|---|---|
| YAMAA-01 | 1 | 100 | |
| YAMAA-01 | 2 | 150 | |
| YAMAA-01 | 1 | 100 |
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 |
|---|---|---|---|---|---|---|---|
| ADEX | STUDYID | Study Identifier | character | Copy value from EX.STUDYID. | Predecessor | ||
| ADEX | USUBJID | Unique Subject Identifier | character | Copy value from EX.USUBJID. | Predecessor | ||
| ADEX | EXSEQ | Sequence Number | numeric | Copy value from EX.EXSEQ. | Predecessor | ||
| ADEX | AVAL | Analysis Value | numeric | Aggregate SUM(EX.EXDOSE) over records matching on the shared output keys. | Derived |
| Template | Include when | AVAL |
|---|---|---|
| administration | Copy EX.EXDOSE |
| 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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