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Summary
README.mdPublic entries: Python and R. Passing coverage requires an installed inventory.
Goal: build the device identifiers dataset, carrying SPDEVID,
DIPARMCD, DIPARM and DIVAL, and submit it with its data-definition
document.
Input: the identifying attributes of each study device as its manufacturer supplies them, one row per attribute.
Variables:
SPDEVIDis the sponsor's identifier for one device.DIPARMCDandDIPARMname the identifying attribute:MODELfor the model number andSERIALfor the serial number.DIVALis that attribute's value as the manufacturer printed it on the device.
Note: the device identifiers follow the medical device supplement to the tabulation guide, but the study cites only the general tabulation guide for its tabulation datasets. The document cannot point the dataset at a guide it does not cite, so the submission stops before any file is written; the dataset itself still builds.
How to fix
Cite the medical device supplement beside the general guide in the tabulation section, which the dataset then names:
sdtm:
standards:
- {name: SDTMIG, version: "3.4", status: Final}
- {name: SDTMIG-MD, version: "1.1", status: Final}
If the dataset follows the general guide instead, remove its
submission.standard, and the dataset takes the section's first guide.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- unknown_standard
- rule
- DEFINE-8
expected/error.yaml
phase: validation
condition: unknown_standard
spec_paths:
- sdtm.specs[0].submission.standard
rule: DEFINE-8
context:
value: SDTMIG-MD
section: sdtm
standards:
- SDTMIG
Inputs
Under review1 source fileinput/devices.csv
Edit2 rows| STUDYID | SPDEVID | DIPARMCD | DIPARM | DIVAL |
|---|---|---|---|---|
| DEV01 | GS-001 | MODEL | Model Number | GS200 |
| DEV01 | GS-001 | SERIAL | Serial Number | SN10458 |
Unexpected Output
Under review2 rows presented to the failing check - not an accepted artifactexpected/di.csv
Edit2 rows| DOMAIN | STUDYID | SPDEVID | DIPARMCD | DIPARM | DIVAL |
|---|---|---|---|---|---|
| DI | DEV01 | GS-001 | MODEL | Model Number | GS200 |
| DI | DEV01 | GS-001 | SERIAL | Serial Number | SN10458 |
Human review and assessment
| Variable Name | Variable Label | Type | Length | Controlled Terms or Format | Origin | Core | Conversion Definition | Variable Type | Variable Order | Comments for Define |
|---|---|---|---|---|---|---|---|---|---|---|
| DOMAIN | Domain Abbreviation | Char | 2 | Assigned | Req | Set constant value "DI". | SDTM | 1 | ||
| STUDYID | Study Identifier | Char | 5 | Protocol | Req | Copy value from DEVICES.STUDYID. | SDTM | 2 | ||
| SPDEVID | Sponsor Device Identifier | Char | 6 | Assigned | Req | Copy value from DEVICES.SPDEVID. | SDTM | 3 | ||
| DIPARMCD | Device Identifier Element Short Name | Char | 6 | Assigned | Req | Copy value from DEVICES.DIPARMCD. | SDTM | 4 | ||
| DIPARM | Device Identifier Element Name | Char | 13 | Assigned | Req | Copy value from DEVICES.DIPARM. | SDTM | 5 | ||
| DIVAL | Device Identifier Element Value | Char | 7 | Collected | Req | Copy value from DEVICES.DIVAL. | SDTM | 6 |
| 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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