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© CDISC 2014 Wayne R. Kubick CDISC CTO 1 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 2
© 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
© 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
© CDISC Technical Plan – Q3 Update 5
© 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)
© 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
9 CFAST and Therapeutic-Area Data Standards: It’s about Patients, People!
© CDISC 2014 Asthma User Guide Example 10
© CDISC 2014 Current CFAST Working Plan 11
© 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
© 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
© 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
© CDISC 2014 The CDISC Standards Process 15
© 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
1 CDASH Initiative: Status Update Bay Area CDISC Implementation Network Meeting - May 29, 2008 Rhonda Facile, Project Director, CDISC Dorothy B. Dorotheo,
BRIDG Model: A Comprehensive Information Model for Biomedical Research 25-April-2006 Douglas B. Fridsma University of Pittsburgh School of Medicine Julie.
11 SHARE S&V Document and the Pilot An Update on CDISC SHARE January 2010 Bron W. Kisler.
Clinical Research and Healthcare – Where is the Link? 24 February 2004 Orlando, FL.
Regulatory Submission Datasets in the World of Evolving Standards Dave Christiansen, DrPH Christiansen Consulting, CDISC Founding Director Safety and the.
Joint TC Meeting: EHR – RCRIM RCRIM Overview HL7 Working Group Meeting January, 2007 Presented by: Ed Tripp Program Director, eSubmissions Abbott (RCRIM.
Out of Cycle HL7 RCRIM Meeting 25 April 2006 Berlin, Germany.
Standards & Interoperability Kickoff HHS – ONC September 20, 2010 Office of Standards and Interoperability 1.
HDF: HL7 Methodology Ioana Singureanu M&M co-chair, HDF Editor Eversolve, LLC.
EMRLD A RIM-based Data Integration Approach Pradeep Chowdhury Manager, Data Integration.
Presentation to RCRIM San Antonio, TX January 15, 2008 Meredith Nahm, M.S. CV/TB Global Data Standards Efforts Therapeutic Area Data Standards: Cardiovascular.
Sergiy Sirichenko DC CDISC User Group Meeting, DC, Updates on CDISC Activities.
Moving from SDTM IG to Overview Monika Kawohl Principal Statistical Programmer Accovion.
New Starter Models for Pharmaceutical Companies and Clinical Research Organisations (CROs) October 2011 Gakava L Roche Products Ltd., Welwyn, UK.
Using the PAHO Guide for Documenting Health Promotion Initiatives.
Cathy Barrows, Ph.D. GlaxoSmithKline Co-Leader of CDISC Pilot Project CDISC ADaM Team An Update on the CDISC SDTM/ADaM Pilot Project FDA/Industry Statistics.
Berlin, February 19, th German CDISC User Group Meeting.
CLINTON W. BROWNLEY AMERICAN UNIVERSITY PH.D. CANDIDATE SEPTEMBER 2, 2009 BRIDGing CDASH to SAS: How Harmonizing Clinical Trial and Healthcare Standards.
Launching of the EU-US eHealth Cooperation Initiative 20 June 2013 Dr. Douglas Fridsma Office of the National Coordinator for Health IT, DHHS Peteris Zilgalvis.
© 2006 Health Level Seven ® All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven, Inc. Reg. U.S.
1 © Health Level Seven ®, Inc. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven, Inc. Reg. U.S.
Invitation to Join Open Health Tools Draft by Skip McGaughey
Query Health Pilots Sub-Work Group December 8, 2011.
Workshop on Metadata Standards and Best Practices November th, 2007 Session 1 Leveraging Metadata Standards in RDC Pascal Heus Open Data Foundation.
27 June 2005caBIG an initiative of the National Cancer Institute, NIH, DHHS caBIG the cancer Biomedical Informatics Grid Arumani Manisundaram caBIG - Project.
Welcome! HL7 Child Health Work Group Webcast June 10, 2009 Dial In: (770) passcode:
Irwin/McGraw-Hill Copyright © 2000 The McGraw-Hill Companies. All Rights reserved Whitten Bentley DittmanSYSTEMS ANALYSIS AND DESIGN METHODS5th Edition.
CDISC Open Source and low-cost Solutions Jozef Aerts XML4Pharma.
Slide 0 EHR SD RM - EHR Way Forward … Future State Reference Architecture HSSP Practitioners Guide Volume II Immunization and Adverse Event Reporting Prototype.
Basel, September 2, rd German CDISC User Group Meeting.
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