CDISC Initiative
CDISC 360i
CDISC 360i is transforming clinical research by digitalizing study design through analysis, making metadata interoperable across the entire study lifecycle.
Traceability
Follow an endpoint from study intent through collection, analysis, and results.
Reuse
Definitions are created once and reused across studies, programs, and therapeutic areas.
Consistency
Shared meaning holds across standards, systems, organizations, and studies.
AI-readiness
Structured semantics support automation, impact analysis, and AI-driven workflows.
360i Video Library
Watch key 360i deliverables in action.
Art of the Possible
Study Design
Data Transfer Agreements
Analysis Concepts
Impact Analysis: one amendment, every artifact it reaches
In a demonstration study, a protocol amendment adjusts how often the primary endpoint is assessed. Because the endpoint definition is connected to every specification and dataset derived from it, the affected artifacts are identified automatically rather than discovered during review.
The change
Protocol amendment, version 2.0
Progression-free survival (PFS) assessment frequency changes from every 12 weeks to every 8 weeks.
Identified as affected
Design
- Schedule of activities
- Biomedical concepts
- Analysis concepts
- Derivation concepts
Specifications
- eCRF specifications
- Data transfer agreement
- Data definition specification
- SDTM Define-XML
- ADaM Define-XML
Collection and data
- Electronic data capture
- External data transfers
- Digital health technologies
- SDTM datasets
- ADaM datasets
Results
- Analysis results datasets
- Tables, figures, and listings
A single change to assessment frequency reaches sixteen connected artifacts. Traceability makes that scope visible at the point of amendment, rather than discovered during review.
The semantic backbone: one definition, five specifications
The semantic backbone is the three layers of structured meaning that make this possible, and every specification below is generated from them rather than authored separately.
Biomedical concepts
Define the clinical meaning and context of the data collected.
Analysis concepts
Define how the endpoint is analyzed.
Derivation concepts
Define how data is derived and transformed.
What it generates
eCRF specifications
Electronic case report form specifications.
Data transfer agreement
Structured agreements for externally sourced data.
Data definition specification
Operational metadata connecting design to collection.
SDTM Define-XML
SDTM metadata specification.
ADaM Define-XML
ADaM metadata specification.
Phase 2 workstreams
Phase 2 is the current stage of 360i, running through 2026 and building the specifications and reference implementations that put the model above into practice. Four workstreams are advancing in parallel across the study lifecycle. Select a workstream for detail on the problem it addresses and what it has delivered.
Study design
Builds and amends schedules of activities that produce machine-readable USDM JSON.
Problem statement
Study teams lack an easy, standards-based way to create and amend a schedule of activities that links protocol activities to biomedical concepts and produces machine-readable USDM JSON for downstream use.
Solution
The SOA Workbench provides a reference implementation for building schedules of activities, associating them with biomedical concepts and dataset specializations from the CDISC Library, generating USDM JSON, and producing amendment impact analysis with traceability.
360i OBJECTIVES ACCOMPLISHED
- Advances end-to-end automation from protocol design
- Creates machine-readable, interoperable study definitions
- Links standards through a semantic layer
- Supports traceability across amendments
- Prepares the foundation for AI-enabled workflows
Deliverables
- Study Design
- Biomedical Concepts
Data definition specification, eCRF, and Define-XML
Generates eCRF specifications and Define-XML from a shared operational metadata model.
Problem statement
Operational metadata needed to generate artifacts such as eCRFs and Define-XML is fragmented across study design, forms metadata, dataset specializations, spreadsheets, and manual refinement steps, making automation difficult and inconsistent.
Solution
The Data Definition Specification model provides an ML-based operational metadata model populated from USDM, biomedical concepts, CRF specializations, dataset specializations, and terminology. The data definition engine demonstrates how that metadata generates eCRFs and Define-XML, including value-level metadata.
360i OBJECTIVES ACCOMPLISHED
- Establishes a reusable operational metadata backbone
- Connects study design to collection and submission metadata
- Provides a foundation for broader standards-driven automation
- Demonstrates metadata-driven generation of downstream artifacts
- Reduces manual Define and CRF specification work
Deliverables
- Data Definition Specification
- eCRF Specifications
- SDTM Define.xml
Data transfer agreement
Turns free-text transfer agreements into structured, exchange-ready specifications.
Problem statement
A large share of clinical trial data comes from external sources, but data transfer agreements are typically free-text documents or vendor-specific spreadsheets that do not link to the protocol, require negotiation, and must be manually reconciled after amendments.
Solution
The digital DTA workstream defines a standards-based model and reference implementation connecting USDM, biomedical concepts, dataset specializations, and Lab v2-style exchange metadata to create structured agreements, map sponsor and provider visits, and export both a DTA document and a machine-readable JSON payload.
360i OBJECTIVES ACCOMPLISHED
- Automates creation and update of data transfer agreements
- Links external data transfers back to protocol intent
- Supports interoperable handoffs between sponsors and service providers
- Reduces negotiation effort through a common framework
- Enables structured, exchange-ready specifications
Deliverables
- Data Transfer Agreement
Analysis concepts
Replaces narrative analysis plans with executable specifications traceable to endpoints.
Problem statement
Statistical analysis plans are usually narrative documents that are ambiguous, incomplete, difficult to reuse, not machine-readable, not executable, and only manually traceable to protocol objectives, endpoints, data, derivations, and results.
Solution
The Analysis Concepts model replaces narrative-only SAP content with a standards-based, executable specification linked to USDM objectives and endpoints. It separates a human-readable specification layer from an executable implementation layer, using reusable concepts, methods, transformations, and code and data bindings.
360i OBJECTIVES ACCOMPLISHED
- Makes the statistical analysis plan machine-readable and testable
- Supports language-agnostic specification with specific execution
- Enables traceability by design from objectives through results
- Extends 360i automation into analysis and results
Deliverables
- Analysis Concepts
- ADaM
- Tables, Figures, and Listings
Digital TAUGs are also advancing in Phase 2 and span all four workstreams.
A seat at the table
Technology vendors on 360i
The Technology Vendor Roundtable brings together leading technology vendors from the CDISC member community to accelerate the development and adoption of CDISC Standards. The roundtable ensures that CDISC standards remain practical, scalable, and aligned with emerging digital workflows.
The roundtable convenes virtually throughout the year and in person at the US Interchange. These sessions enable vendors and developers to build tools that integrate with CDISC structured standards metadata and digital protocol models, supporting automation, improving data quality, and reducing inefficiencies across the research continuum.
Join the roundtable
Open to technology vendors in the CDISC member community.
Start building
The 360i notebooks and reference implementations are open source and public.
Catalyst for automation
The AI Innovation Challenge
The CDISC AI Innovation Challenge is a global contest that advances the digitization and automation of clinical research using AI, machine learning, and CDISC Standards. Its use cases are drawn directly from the gaps 360i is working to close, and winning solutions demonstrate what becomes possible when standards are implemented as connected metadata.
Submissions for the 2026 Challenge closed on 31 July. Winners will be announced and showcased at the 2026 US Interchange in Denver this October.
Upcoming Events
360i Webinar Archive
Upcoming 360i Webinars
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