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What ’ s New with CDISC

What ’ s New with CDISC. Wayne R. Kubick CDISC CTO. 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. The CDISC Mission.

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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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