© CDISC 2014

Wayne R. KubickCDISC CTO

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What’s New with CDISC

© 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

2014 Technical Plan – Q3 Update

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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)

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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

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CFAST and Therapeutic-Area Data Standards:

It’s about Patients, People!

© CDISC 2014

Asthma User Guide Example

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© CDISC 2014

Current CFAST Working Plan

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© 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

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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

The CDISC Standards Process

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© 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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