Analysis Concepts: A Standard for Executable Clinical Analysis

About this session

Part of Session 2: CDISC Plenary - 360i Vision & Roadmap (Chair: Julie Smiley, CDISC).

Statistical Analysis Plans have long been written as narrative text — ambiguous, incomplete, and impossible for machines to act on. The Analysis Concepts Framework, developed by the CDISC Analysis Concepts Working Group as part of the 360i initiative, directly addresses this gap by providing a structured, standards-based approach to expressing derivations and statistical analyses in a machine-readable and executable form.
Central to the framework is a strict separation between a specification layer — abstract, semantic, and language-agnostic — and an execution layer that binds concepts to data standards and code. Key components include Methods, Transformations, Concepts, Data Bindings, and Smartphrases, together enabling platform-independent code generation and bidirectional traceability from results back to USDM.
This presentation marks the release of Version 1, providing an updated overview of the framework, its linkages to USDM, ADaM, and ARS, and a demonstration of an eSAP being built and executed end to end.

Speaker

• ES

  Edwin van Stein

  Senior Consultant, Data Standards · CDISC

  Speaker