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What ’ s New with CDISC

This presentation by CDISC CTO Wayne R. Kubick provides an overview of CDISC standards, tools, and processes, as well as updates on current and upcoming products. Learn about CDISC's mission and how data standards improve clinical research. Discover the role of SHARE, CDISC's standards metadata repository. Find out how to access published standards and get involved in CDISC and CFAST projects.

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What ’ s New with CDISC

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  1. What’s New with CDISC Wayne R. KubickCDISC CTO

  2. Agenda:Things Old, Things New and Things to Come • CDISC Standards and Me • Foundational Standards • Therapeutic Area Standards • SHARE Metadata • Tools and Processes • CDISC Standards and You

  3. The CDISC Mission The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. Wayne’s Mission Data Standards to Improve Clinical Research

  4. What is a CDISC Data Standard? A CDISC data standard is any product (including specifications, user guides, implementation guides, models or schemas) provided by CDISC that describes representation of clinical* research data and has been properly developed, vetted and approved through the CDISC process.    * And non-clinical

  5. 2014 Technical Plan – Q3 Update

  6. Progress Update – Foundational Stds • Products Released in 2014: • Dataset-XML v1 Final • SDTMIG 3.3 Batch 1 (4 draft domains) • ADaM Occurrence Data Structure v1 Draft • ADaM IG v1.1 Draft • Quarterly Terminology and Periodic QS Supplements • Updated COP-001 and Process Docs • ADaM Results Metadata Specification • Upcoming New Drafts for Comment: • Pharmacogenomics IG v1 Draft • SEND v3.1 Draft • SDTM Batch 2 (Disease Milestones, Domains)

  7. Bridging the Silos: Governing the SDTM Product Family SDTMIG QS Supplements SDTMIG-AP Associated Persons SDTMIG-PGx Pharmacogenomics SDTMIG Human Clinical SEND IG Non-Clinical SDTMIG-MD Medical Devices Study Data Tabulation Model (SDTM) CDISC Therapeutic Area User Guides

  8. CFAST and Therapeutic-Area Data Standards: It’s about Patients, People!

  9. Asthma User Guide Example

  10. Current CFAST Working Plan

  11. CDISC Technical Roadmap - 2014 SEND Foundational Standards Data Exchange Layer XML, RDF, … SDS/SDTM Products CDASH Semantic Layer BRIDG/Terminologies/SHARE PROTOCOL ADAM Functional Layer SDTM, SEND, ADaM, CDASH … Others XML Technologies Semantics Implementation Layer Therapeutic Area Guides, Questionnaire Guides Healthcare Interoperability Kits BRIDG CDISC SHARE R1 R2 R3 Controlled Terminology Therapeutic Areas (CFAST) Track 1 Projects Track 2 Projects Track 3 Projects Health Care Interoperability The Roadmap depicts evolution from siloed standards to an integrated stack based on BRIDG and SHARE

  12. What is SHARE? • SHARE is a standards metadata repository for authoring, governing, and publishing CDISC standards • SHARE combines • SOA Semantics Manager • ISO 11179 Metadata Model • CDISC Standards Model • CDISC Foundational and TA Standards • Controlled Terminology • Exports to ODM, Define-XML and RDF • Enables the development of a consistent, end-to-end standards model 13

  13. User Perspectives of SHARE Standards Development & Governance Accessing Published Standards in a Machine-Readable Format

  14. The CDISC Standards Process

  15. Opportunities for Participation in CDISC and CFAST Projects • Read and provide comments on CDISC standards posted for review • Volunteer for CDISC teams at any time through the CDISC Website • Respond to a CFAST call for participation for specific roles on named projects (e.g., Clinical SME for Dyslipidemia, Medical Writer Diabetic Nephrology) • Seek management approval to apply for a position in the proposed new CDISC Fellows Program – discussed in this presentation • This will both maintain continuity between CFAST projects as well as build expertise in sponsoring organizations (Industry, CROs, Vendors) • Participate in the future collective management of CDISC standards as part of a proposed new CDISC SHARE Metadata Curation Collaboration initiative • Planned for 2015 -- details to be discussed separately later.

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