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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. - PowerPoint PPT Presentation
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© 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
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© 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.
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Wayne’s Mission
Data Standards to Improve Clinical Research
© 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
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© CDISC 2014
Progress Update – Foundational Stds
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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)
© CDISC 2014 7
Bridging the Silos:Governing the SDTM Product Family
Study Data Tabulation Model (SDTM)Study Data Tabulation Model (SDTM)
SDTMIGHuman Clinical
SDTMIG-MDMedical Devices
SEND IGNon-Clinical
SDTMIG-PGxPharmacogenomics
SDTMIG-APAssociated Persons
SDTMIG QSSupplements
© CDISC 2014
CDISC Technical Roadmap - 2014 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 LayerXML, RDF, …
Semantic LayerBRIDG/Terminologies/SHARE
Functional LayerSDTM, SEND, ADaM, CDASH …
Implementation LayerTherapeutic Area Guides, Questionnaire GuidesHealthcare Interoperability Kits
SDS/SDTM Products
CDASH
SEND
Others
ADAM
PROTOCOL
Controlled Terminology
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The Roadmap depicts evolution from siloed standards to an integrated stack based on BRIDG and SHARE
© CDISC 201413
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
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© CDISC 2014
User Perspectives of SHARE
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Standards Development & Governance
Accessing Published Standardsin a Machine-Readable Format
© 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 2015 -- details to be discussed separately later.
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