Supported standards¶
yamaa generates clinical and nonclinical datasets, Define-XML metadata and SAS Transport version 5 files for the implementation guides below. A study declares its guide explicitly and supplies the dataset content, terminology and analysis rules that follow that guide.
Clinical guides¶
| Model | Implementation guide versions | Minimum supported pair |
|---|---|---|
| SDTM | 3.3, 3.4 | SDTM 1.7 / SDTMIG 3.3 |
| ADaM | 1.1, 1.2, 1.3 | ADaM 2.1 / ADaMIG 1.1 |
SDTMIG 3.4 uses SDTM 2.0. Every listed ADaMIG version uses ADaM 2.1. The minimum-version badges refer to this finite list of published guides; a future version needs its own compatibility checks before joining it.
For example, a project can select the minimum guides independently:
yamaa: "1.0"
type: project
study:
id: STUDY01
name: STUDY01
description: Clinical study
protocol_name: STUDY01
sdtm:
specs: [sdtm/dm.yaml]
standards:
- {name: SDTMIG, version: "3.3", status: Final}
define: sdtm/define.xml
transport: xpt
adam:
specs: [adam/adsl.yaml]
standards:
- {name: ADaMIG, version: "1.1", status: Final}
define: adam/define.xml
transport: xpt
Define-XML and controlled-terminology releases are separate choices. An older implementation guide can use Define-XML 2.1; selecting SDTMIG 3.3 or ADaMIG 1.1 does not require Define-XML 2.0 or a terminology release from the guide's publication year. The project codelist sources declare the terminology releases the study actually uses.
Nonclinical guide¶
| Model | Implementation guide version | Supported pair |
|---|---|---|
| SEND | 3.1.1 | SDTM 1.5 / SENDIG 3.1.1 |
SENDIG 3.1.1 uses SDTM 1.5. A nonclinical project lists its specifications,
each declaring model: SEND, in its own send section, which composes its
own Define-XML document:
send:
specs: [send/bw.yaml]
standards:
- {name: SENDIG, version: "3.1.1", status: Final}
define: send/define.xml
transport: xpt
SEND datasets take the tabulation classes, roles and core designations of SDTM. An origin's source is optional under SEND, since a nonclinical study identifies its test facility in its trial summary, so a value the facility collected needs no annotated case report form.
Compatibility coverage¶
The independently authored benchmarks compare derived rows, complete Define-XML documents and XPT v5 bytes. The shared qualification readers run them through the Python and R hosts. XPT expectations come from an independent encoder of the public transport layout and are also read with an independent reader. The generated XML is checked against CDISC's XSD.
| Guide | Benchmark | What it exercises |
|---|---|---|
| SDTMIG 3.3 | Demographics | Required and expected metadata, missing dates, numeric and text transport |
| SDTMIG 3.3 | Subject visits | The 3.3 visit layout, fractional visit numbers, a visit spanning days and an unplanned visit |
| SDTMIG 3.3 | Morphology | The MO domain retained in 3.3, collected and standardized findings, and timing roles |
| ADaMIG 1.1 | Subject-level analysis | Subject keys, treatment metadata, numeric dates and datetimes, and display formats |
| ADaMIG 1.1 | Laboratory analysis | BDS parameters, subject-level treatment joins, relative days, repeated baseline, change and absent baseline |
| ADaMIG 1.1 | Adverse-event analysis | Occurrence data, partial onset times, imputation flags and numeric analysis date/time transport |
| ADaMIG 1.2 | Subject-level analysis | An explicit intermediate guide declaration with the same date/time transport contract |
| SENDIG 3.1.1 | Body weights | A nonclinical findings domain, routine and terminal weighings, standardized numeric results and unsourced collected origins |
The existing submission benchmarks retain SDTMIG 3.4 and ADaMIG 1.3 coverage. The new examples select the older content directly: MO remains a 3.3 domain, and the 3.3 SV example carries no 3.4-only visit variables.
This is generation and export compatibility. The engine checks the study's declared metadata and verifications; it does not contain the full catalog of every guide's domain, variable and business rules. From 1.0.0, a new conformance check arrives only as an opt-in, through a new optional field, never as a new refusal or a new run-report row for a file that an earlier 1.x release admitted, as the stability contract says. Study teams validate their complete submission against the selected guide and applicable FDA rules. Changing the guide declaration alone does not convert newer content into a conforming older dataset.
FDA submission use¶
The minimum pairs above are supported clinical options in FDA Data Standards Catalog v11.0, which also lists SENDIG 3.1.1 for nonclinical studies. FDA eligibility depends on the study start date, submission type and reviewing center. See the current FDA catalog and study-data requirements when planning a submission.
CDISC's SDTMIG 3.3, SENDIG 3.1.1 and ADaM compatibility table identify the underlying models and applicable companion documents. Their errata and the selected occurrence-data guide remain part of the study's standards assessment.
Historical metadata reproduction remains available for older received declarations. Its literal metadata does not establish generation support for every version string it can record.