CDISC Conformance Rules are an integral part of the Foundational Standards and provide specific guidance to industry for the correct implementation of the standards. 
The CDISC Open Rules are openly governed, machine-executable representations of CDISC Conformance Rules and regulatory business rules. 

Conformance Rules: 

• Are published in Excel format and are not machine-executable 
• Can be interpreted and implemented differently across organizations 
• Could lead to inconsistencies in data validation and regulatory submissions 

As industry best practice shifts towards applying Conformance Rules throughout the study lifecycle, to keep data as submission ready as possible, the need for a unified, reliable approach has become essential. 

CDISC Open Rules directly address this need by providing an aligned, transparent, and machine-executable rules framework that supports consistency from study design through regulatory submission. 

Key Objectives 

• Deliver a governed set of unambiguous and executable Conformance Rules (CDISC Open Rules) for each Foundational Standard 
• Provide an open-source reference implementation, the CDISC Open Rules Engine (CORE), that executes the CDISC Open Rules
• Certify engines that execute the CDISC Open Rules with results consistent with the reference implementation

Highlights and Current Status 

• CDISC Open Rules packages for SDTMIG v3.2, v3.3, and v3.4 and FDA Business Rules (SDTM) are available in CDISC Library and run on CORE V1.0 
• CORE V1.0, released 3 November 2026, is the first production release of the engine. Its PostgreSQL-based architecture is built to process production-scale study data 
• CDISC Open Rules for TIG v1.0 and USDM v3.0 and v4.0 are available and run on CORE V0.17.1 
• Rules for SENDIG, ADaM, and nonclinical FDA Business Rules are in development 
• CDISC is moving toward a machine-readable rule model that separates what the rules are from how they are executed, enabling multiple interoperable and certified implementations 
• The next phase depends on adopters, volunteers, and technology partners working together. The governance group will organize and facilitate an industry pilot and guide the rule model initiative (see What's Next below) 

Benefits to the CDISC Community 

• Ensures each standard has a set of unambiguous, machine-executable rules 
• Delivers CDISC Open Rules based on Conformance Rules vetted by the CDISC standards development teams 
• Ensures consistency across Conformance Rule implementations 
• Expedites the availability of CDISC Open Rules for new Foundational Standards 
• Allows the same rules to run on any certified engine with consistent results 

What's Next 

Two efforts will shape CDISC Open Rules after the CORE V1.0 release: 

• Governance group. CDISC is forming a governance group with the organizations and contributors who helped build the CDISC Open Rules. The group will guide how rules are prioritized, reviewed, and published, and will steer the rule model initiative. 

• Industry pilot. The governance group will set up and manage an industry pilot that runs CDISC Open Rules on production study data and compares the results with current validation tools. Details will be shared as the pilot takes shape.

   

Learn more in the CDISC Open Rules CORE V1.0 release webinar on 10 November 2026.