Standards and product evidence
The model uses standards and public product behaviour as evidence. None is copied wholesale, and none is allowed to dictate aggregate boundaries without a domain reason.
Primary standards
Section titled “Primary standards”- ICH E6(R3) Good Clinical Practice — responsibilities, data governance, protocol content, and essential records.
- CDISC Unified Study Definitions Model v4.0 — structured study design, controlled terminology, and downstream consumption of digital protocol definitions.
- CDISC ODM v2.0 — clinical data, metadata, administrative data, reference data, and audit information exchange.
- CDISC SDTM v2.0 — conceptual representation of clinical study data for downstream use.
- TMF Reference Model v3.3.1 resources — standardized artifact taxonomy, metadata, process association, and filing-level guidance.
Interpretation policy
Section titled “Interpretation policy”- USDM is the principal alignment target for study-design semantics, not a mandatory internal class hierarchy.
- ODM is an exchange model; exchange cardinality does not automatically define an aggregate boundary.
- The TMF Reference Model classifies content;
EssentialRecordadds record-instance behaviour and evidence decisions.