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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: carry each administration with its study day in ASTDY, its
number among the subject's administrations in ADOSENUM, the dose given in
AVAL, and the dose the schedule plans for that administration in
PLANDOSE.
Input: exposure records, one per administration, carrying the study day
(EXSTDY) and the dose given (EXDOSE), and a dosing schedule giving the
planned dose (PLANDOSE) of each administration number (DOSENUM).
Variables:
ADOSENUMwould number each subject's administrations from 1, by study day.PLANDOSEwould be the planned dose of the administration's number, and blank when the schedule plans none.
Note: an administration's number counts all of the subject's administrations, so it is numbered only after every record is built. The planned dose is looked up while each record is being built, before any administration has a number, so the run is rejected before any data is read and no artifact is accepted.
How to fix
Look the planned dose up after the records are built, by deriving PLANDOSE
for every record once ADOSENUM is numbered:
- name: PLANDOSE
type: float
label: Planned Dose
derivation: PLANNED.PLANDOSE
Then remove PLANDOSE from the row template's derivations.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- phase_boundary
- rule
- LOOKUP-2
expected/error.yaml
phase: validation
condition: phase_boundary
spec_paths:
- rows.administered.derivations.PLANDOSE.source
rule: LOOKUP-2
context:
identifier: ADOSENUM
intermediate: PLANNED
row: administered
available_phase: column_derivation
required_phase: row_construction
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 |
|---|---|---|---|---|---|---|---|
| ADEX | STUDYID | Study Identifier | character | Set per constructed row; see the Row construction sheet. | Derived | ||
| ADEX | USUBJID | Unique Subject Identifier | character | Set per constructed row; see the Row construction sheet. | Derived | ||
| ADEX | ASTDY | Analysis Start Relative Day | numeric | Set per constructed row; see the Row construction sheet. | Derived | ||
| ADEX | ADOSENUM | Administration Number | numeric | Row number within each group of STUDYID, USUBJID, ordered by ASTDY. | Derived | ||
| ADEX | AVAL | Analysis Value | numeric | Set per constructed row; see the Row construction sheet. | Derived | ||
| ADEX | PLANDOSE | Planned Dose | numeric | Set per constructed row; see the Row construction sheet. | Derived |
| Template | Include when | STUDYID | USUBJID | ASTDY | AVAL | PLANDOSE |
|---|---|---|---|---|---|---|
| administered | Copy EX.STUDYID | Copy EX.USUBJID | Copy EX.EXSTDY | Copy EX.EXDOSE | Copy PLANDOSE from the SCHEDULE record whose DOSENUM equals ADOSENUM, and no match yields blank |
| 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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