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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
CDISC Technology HITSP, 15 th October 2008 Dave Iberson-Hurst CDISC VP Technical Strategy 1.
From PDF to RDF – Representing the CDISC Foundational Standards Geoff Low Frederik Malfait, IMOS Consulting Scott Bahlavooni, d-Wise Mitra Rocca, FDA CTS.
Geneva Branch INTRODUCTION TO CDISC Biometristi Italiani Associati – Seminario BIAS CDISC SDTM and ADaM: Moving from theory to practice SAS Institute –
Copyright © 2013, SAS Institute Inc. All rights reserved. MANAGING AND ANALYZING CLINICAL DATA MARK LAMBRECHT, PRINCIPAL INDUSTRY CONSULTANT, SAS BIAS.
Second Annual Japan CDISC Group (JCG) Meeting 28 January 2004 Julie Evans Director, Technical Services.
RCRIM Projects: Protocol Representation and CDISC Message(s) January 2007.
© CDISC 2014 Sam Hume Sept 16 th, CAC eSHARE Update.
Restricted © Business & Decision Life Sciences 2014 All rights reserved. Business & Decision Life Sciences CD03: What’s new in ADaM Gavin Winpenny 13 October.
Sergiy Sirichenko NJ CDISC User Group Meeting, NJ, Updates on CDISC Activities.
CDISC and how Stata can help us implement it Dr Adam Jacobs Dianthus Medical Limited.
© CDISC SHARE TA Research Concepts Pilot. © CDISC 2014 SHARE TA RC Pilot SHARE TA RC Pilot: Bringing together the TA Project RC experience with.
Overview of CDISC standards and use cases along the E2E data management process Dr. Philippe Verplancke ESUG Marlow, UK 27 May 2009.
Emerging Technologies Semantic Web and Data Integration This meeting will start at 5 min past the hour As a reminder, please place your phone on mute unless.
© CDISC CDISC Day – Milano Europe CDISC Coordinating Committee (E3C) CDISC Operations CDISC Europe Foundation 30 September 2015.
© CDISC CDISC Roadmap © CDISC CDISC Strategic Goals #1 Promote and support the continued global adoption of.
Health IT Workforce Curriculum Version 1.0 Fall Networking and Health Information Exchange Unit 3b National and International Standards Developing.
© CDISC 2012 Pierre-Yves Lastic Sanofi R&D, Chair-Elect, CDISC Board of Directors Réunion du Groupe des Utilisateurs Francophones des standards CDISC,
Moving from SDTM IG to Overview Monika Kawohl Principal Statistical Programmer Accovion.
CDISC©2009 February CDISC INTRAchange Carey Smoak Device Team Leader Li Zheng Submission Data Standards Team Member Thurday, April 2, 2009.
Briefing: HL7 Working Group Meeting Update for the VCDE Community Dianne M. Reeves Associate Director, Biomedical Data Standards NCI CBIIT VCDE Meeting.
CLINTON W. BROWNLEY AMERICAN UNIVERSITY PH.D. CANDIDATE SEPTEMBER 2, 2009 BRIDGing CDASH to SAS: How Harmonizing Clinical Trial and Healthcare Standards.
© CDISC: Global Approach To Accelerating Medical Research.
Submission Standards: The Big Picture Gary G. Walker Associate Director, Programming Standards, Global Data Solutions, Global Data Management.
1. © CDISC 2014 SDS ELT Rules Team Update Stetson Line 08 Dec
CDISC Open Source and low-cost Solutions Jozef Aerts XML4Pharma.
Bay Area CDISC Implmentation Network – July 13, 2009 How a New CDISC Domain is Made Carey Smoak Team Leader CDISC SDTM Device Team.
Joint TC Meeting: EHR – RCRIM RCRIM Overview HL7 Working Group Meeting January, 2007 Presented by: Ed Tripp Program Director, eSubmissions Abbott (RCRIM.
Kopenhagen, 22 April 2008 German CDISC User Group.
CDISC XML Technologies Standards Development An Update Sam Hume
© CDISC 2012 Pierre-Yves Lastic, PhD Chair-Elect, CDISC Board of Directors Chief Privacy Officer, Sanofi 1 Board Chair’s Update 2013 and Vision for CDISC.
© CDISC 2015 Paul Houston CDISC Europe Foundation Head of European Operations 1 CTR 2 Protocol Representation Implementation Model Clinical Trial Registration.
Accenture Accelerated R&D Standards Metadata Management – version control and its governance Kevin Lee CDISC NJ Meeting at 01/28/2015 We help our Clients.
Roche Global Data Standards Repository (GDSR)... and how the Clinical Programmers work with it Antje Rossmanith, Roche 14th German CDISC User Group, 25-Sep-2012.
1 RCRIM Vocab-BRIDG Session Wednesday, Session Q2 19 September 2007.
CDISC Update December 2007 / January 2008 Pierre-Yves Lastic, PhD CDISC Board of Directors & E3C February 5, Paris.
SDTM Validation Rules Sub-team Kickoff Meeting January 24 th, 2014.
Mark Wheeldon, Formedix CDISC UK Network June 7, 2016 PRACTICAL IMPLEMENTATION OF DEFINE.XML.
1 CDASH Initiative: Status Update Bay Area CDISC Implementation Network Meeting - May 29, 2008 Rhonda Facile, Project Director, CDISC Dorothy B. Dorotheo,
CDISC ADaM 2.1 Implementation: A Challenging Next Step in the Process Presented by Tineke Callant
Basel, September 2, 2008 Work Stream Summary define.xml/eSubmissions.
© CDISC 2012 CDISC and IHE’s contribution to EHR-enabled research Becky Kush George Cole Landen Bain.
Beyond regulatory submission - Standards Metadata Management Kevin Lee CDISC NJ Meeting at 06/17/2015 We help our Clients deliver better outcomes, so they.
Copyright © 2014, SAS Institute Inc. All rights reserved. SAS® TOOLS FOR WORKING WITH DATASET-XML FILES Lex Jansen Principal Software SAS CDISC.
© CDISC 2011 Joint Initiative Council 18 October 2011 Bron Kisler, VP, Strategic Initiatives, Current JIC Leader Rebecca D. Kush, PhD, President and CEO,
HL7 Study Data Standards Project Crystal Allard CDER Office of Computational Science Food and Drug Administration February 13,
Presentation to RCRIM San Antonio, TX January 15, 2008 Meredith Nahm, M.S. CV/TB Global Data Standards Efforts Therapeutic Area Data Standards: Cardiovascular.
© CDISC 2014 Asthma TAUG Metadata Bundle Review – Experimental Content PhUSE Computational Science Symposium March th, 2015 Sam Hume 1.
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