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© CDISC 2014 Wayne R. Kubick CDISC CTO 1 What’s New with CDISC.

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Presentation on theme: "© CDISC 2014 Wayne R. Kubick CDISC CTO 1 What’s New with CDISC."— Presentation transcript:

1 © CDISC 2014 Wayne R. Kubick CDISC CTO 1 What’s New with CDISC

2 © CDISC 2014 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 2

3 © CDISC 2014 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. 3 Wayne’s Mission Data Standards to Improve Clinical Research

4 © CDISC 2014 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 4

5 © CDISC Technical Plan – Q3 Update 5

6 © CDISC 2014 Progress Update – Foundational Stds 6 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 © CDISC Bridging the Silos: Governing the SDTM Product Family Study Data Tabulation Model (SDTM) SDTMIG Human Clinical SDTMIG-MD Medical Devices SEND IG Non-Clinical SDTMIG-PGx Pharmacogenomics SDTMIG-AP Associated Persons SDTMIG QS Supplements

8 © CDISC

9 9 CFAST and Therapeutic-Area Data Standards: It’s about Patients, People!

10 © CDISC 2014 Asthma User Guide Example 10

11 © CDISC 2014 Current CFAST Working Plan 11

12 © CDISC 2014 CDISC Technical Roadmap Foundational Standards Semantics Therapeutic Areas (CFAST) CDISC SHARE R1 R2 R3 BRIDG Track 1 Projects Track 2 Projects Track 3 Projects XML Technologies Health Care Interoperability Data Exchange Layer XML, RDF, … Semantic Layer BRIDG/Terminologies/SHARE Functional Layer SDTM, SEND, ADaM, CDASH … Implementation Layer Therapeutic Area Guides, Questionnaire Guides Healthcare Interoperability Kits SDS/SDTM Products CDASH SEND Others ADAM PROTOCOL Controlled Terminology 12 The Roadmap depicts evolution from siloed standards to an integrated stack based on BRIDG and SHARE

13 © CDISC What is SHARE? SHARE is a standards metadata repository for authoring, governing, and publishing CDISC standards SHARE combines  SOA Semantics Manager  ISO 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

14 © CDISC 2014 User Perspectives of SHARE SHARE iSHARE (SHARE Interactive) eSHARE (SHARE Exports) 14 Standards Development & Governance Accessing Published Standards in a Machine-Readable Format

15 © CDISC 2014 The CDISC Standards Process 15

16 © CDISC

17 © CDISC 2014 Opportunities for Participation in CDISC and CFAST Projects 1.Read and provide comments on CDISC standards posted for review 2.Volunteer for CDISC teams at any time through the CDISC Website 3.Respond to a CFAST call for participation for specific roles on named projects ( e.g., Clinical SME for Dyslipidemia, Medical Writer Diabetic Nephrology) 4.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) 5.Participate in the future collective management of CDISC standards as part of a proposed new CDISC SHARE Metadata Curation Collaboration initiative  Planned for details to be discussed separately later. 17

18 © CDISC


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