CORE

CDISC Conformance Rules are an integral part of the Foundational Standards and serve as the specific guidance to Industry for the correct implementation of the Standards in clinical studies.  An emerging Industry best practice is to use Conformance Rules on an ongoing basis, throughout the study, to keep the data as close to submission ready as possible and to ensure quality in all data exchange scenarios.

Current CDISC Conformance Rules need to be expressed in a common specification to be loaded to the CDISC Library. In addition, an executable component must be developed for every Conformance Rule.

Project Goals and Objectives

The overall goal of the CORE Project is to deliver a governed set of unambiguous and executable Conformance Rules for each Foundational Standard, and to provide a minimum viable product of an open-source execution engine for the executable Rules.

CDISC is partnering with Microsoft to develop the CDISC Open Rules Engine (CORE), open-source software, which will execute machine-readable CDISC Conformance Rules retrieved from the CDISC Library. The global clinical research community will be able to leverage the free and open, Microsoft Azure-based CORE software to test study data for conformance to CDISC standards as well as to regulatory and sponsor-specific conformance rule sets.

The CORE Project objectives are to:

  • Ensure each standard has a set of unambiguous, executable Conformance Rules
  • Ensure consistency across Conformance Rule implementations
  • Expedite the availability of executable Conformance Rules for new Foundational Standards
  • Create executable Conformance Rules vetted by the CDISC standards development teams
  • Release the Rules under the CDISC Open Source Alliance (COSA)
  • Create an open-source engine that executes the Rules
Further Considerations
  • The executable rules are the next step in the evolution of the Conformance Rules that CDISC publishes with every standard
  • Executable Conformance Rules available via CORE should make it much easier for rule vendors to adapt these rules for use in their software
  • CORE will be released as open source under the MIT license; it will not be offered by CDISC as a commercial product or service
  • Existing rule vendors are free to contribute to, or use, the CORE software
Project Concept Diagram

The following diagram illustrates the concept of the CORE project, including the Conformance Rules, the executable form of the Rules, and the Rules’ execution engine:

Stakeholders
  • CDISC will collaborate with Industry to develop a specification of the Rules.
  • Industry will collaborate with CDISC to create, govern, and maintain the Rules.
  • Microsoft will develop the Rules’ execution engine and interface.
Teams

The following diagram identifies the project teams:

Team Diagram
Minimum Viable Product Timeline
  • Initiation:  Q2 2021
  • Planning:   Q2 2021
  • Execution: Q3 2021 – Q1 2022
  • Closure:     Q1 2022
     
How to Participate

We invite your organization to participate in this exciting new project.
Please visit the CORE Project Participate page to learn more.
 

Additional Resources
CORE Charter

CORE Slide Deck

CORE Press Release

 

The CORE Project seeks participants for the following teams:

 

  • Conformance Rules Development
  • Quality Assurance

Conformance Rules Development Team

  • Mission:
    • Develop the rules specification and the executable form of the rules
       
  • Work Areas:
    • Specification structure and content
    • Executable rules content
       
  • Roles and Experience:
    • Rule Developer
      • Experience developing conformance rules and/or using conformance rules to check clinical data
      • Strong knowledge of SDTM/SDTMIG
      • Experience with regulatory submissions

Quality Assurance Team

  • Mission:
    • Develop and execute validation plan for rules specification and executable form of rules
       
  • Work Areas:
    • Analysis and development of validation plan
    • Analysis and development of test data
    • Execution of validation plan
      • Execute CORE engine for executable rules and test data
      • Report and analyze test results
      • Coordinate with Software Engineering Dev team on test results
         
  • Roles and Experience:
    • Validation Lead
      • Experience developing computer system validation plans, leading teams during validation plan execution, and analyzing and reporting test results
    • Computer System Validation Specialist
    • Technical Writer
    • Security Engineer

Expected Engagement

  • Project Execution Period
    • Q3 2021 – Q1 2022 (about 9 months)
       
  • Expected FTE level
    • Minimum 20%
       
  • Meeting Cadence
    • Team meeting once or more per week, as determined by team

 

CORE Project Call-for-Participation Webinar

CDISC held a webinar 20 July 2021 to provide a deeper understanding of the CORE project, share the “ask” of participants and answer questions from attendees. We invite you to listen to the webinar recording to learn more.

 

Sign-up Instructions

  • If you would like participate in this exciting effort, sign up on the CDISC volunteer page and indicate CORE on the form as the Standards Development team. Please include which CORE team you would like to join in the box at the bottom of the page.

CDISC held a webinar 20 July 2021 to provide a deeper understanding of the CORE project, share the “ask” of participants and answer questions from attendees. We invite you to listen to the webinar recording to learn more.