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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: carry the subject randomization date RANDDT from
demographics into the subject-level analysis file.
Input: a subject-level demographics file holding the study and
subject identifiers with RANDDT, produced from an Operational
Data Model (ODM) extract.
Variables:
RANDDTwould be the subject's randomization date, taken fromRANDDTin the demographics file.
Note: the date's value kind is already fixed where the demographics file is produced. Stating it again beside the source would leave two authorities for the same field even when they agree, so the run is rejected before any data is read and no artifact is accepted.
How to fix
Keep the producing DM specification as the single type authority and remove
the inline types entry:
input:
DM:
path: input/dm.csv
schema: input/dm.schema.yaml
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- redundant_field_type
- rule
- INPUT-6
expected/error.yaml
phase: validation
condition: redundant_field_type
spec_paths:
- input.DM.types.RANDDT
rule: INPUT-6
context:
dataset: DM
field: RANDDT
type: date
Inputs
Under review3 source filesinput/dm.csv
Edit1 row| STUDYID | USUBJID | RANDDT |
|---|---|---|
| YAMAA-01 | 2025-01-12 |
input/dm.schema.yaml
Edityamaa: "1.0"
type: spec
domain: DM
keys: [STUDYID, USUBJID]
input:
ODM: odm.csv
output:
path: dm.csv
columns: [STUDYID, USUBJID, RANDDT]
columns:
- name: STUDYID
type: str
label: Study Identifier
derivation: ODM.StudyOID
- name: USUBJID
type: str
label: Unique Subject Identifier
derivation: ODM.SubjectKey
- name: RANDDT
type: date
label: Date of Randomization
derivation: ODM.Value
rows:
- id: subject
filter: "ODM.ItemOID = 'IT.DM.RANDDT'"
input/odm.csv
Edit1 row| StudyOID | MetaDataVersionOID | SubjectKey | StudyEventOID | StudyEventRepeatKey | ItemGroupOID | ItemGroupRepeatKey | ItemOID | Value |
|---|---|---|---|---|---|---|---|---|
| YAMAA-01 | MDV.1 | YAMAA-01-001 | SCREENING | 1 | IG.DM | 1 | IT.DM.RANDDT | 2025-01-12 |
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 | RANDDT | Date of Randomization | numeric | ISO 8601 | Copy value from DM.RANDDT. | Predecessor |
| 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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