1. © CDISC 2015 1 CDISC Day – Milano Europe CDISC Coordinating Committee (E3C) CDISC Operations CDISC Europe Foundation 30 September 2015

2. © CDISC 2015 2 Peter Van Reusel Business & Decision Life Sciences Bron Kisler CDISC Isabella Montagna Chiesi Farmaceutici (local CDISC implementation) Paul Houston CDISC Introductions Diana Harakeh CDISC Andrea Rauch Boehringer Ingelheim Jörg Dillert Oracle Mark Lambrecht SAS

3. © CDISC 2015 3 E3C Update: The 14 th Year Peter Van Reusel Chair, CDISC E3C

4. © CDISC 2015 4 E3C Charter Purpose  Yearly action plan, aligned with CDISC Strategic Goals  Organize & Promote CDISC Interchanges for Europe  Liaise with regulatory authorities on behalf of CDISC  Assess regional CDISC training needs  Assist in the creation & coordination of European User Networks  Communicate activities Composed of volunteers  Sponsors  CRO  Vendors  Academia Represent Europe

5. 5 Annual Meetings Workshops  Frankfurt 2002  Dublin 2003 Interchanges  Brussels 2004  Paris 2005  Berlin 2006  Montreux 2007  Copenhagen 2008  Budapest 2009  London 2010  Brussels 2011  Stockholm 2012  Frankfurt 2013  Paris 2014  Basel 2015  Vienna 2016 Paris London Brussels Dublin Budapest Stockholm Copenhagen Frankfurt Berlin Basel Montreux Vienna

6. 6 CDISC Europe Interchange Vienna, Austria – 25-29 April 2016 Become a Sponsor Today Place Your Logo on this Banner to be Displayed on the CDISC Website!

7. © CDISC 2015 7 Foundational Products Released in 2015: SENDIG v3.1 Draft B ADaM Occurrence Data Structure v1 ADaM Results Metadata Spec for Define-XML 2.0 ADaM Validation Checks v1.3 Pharmacogenomic SDTMIG v1 CDISC in RDF Reference Guide v1 Final (PhUSE) Periodic Terminology and COA Packages Updated COP and Process Docs SDTMIG 3.3 Draft SDTM v1.5 Draft ADaM v2.1 Draft Upcoming New Drafts for Comment: CDASH v2 and Model ADaM Standards in Development / Future Plans Progress Update – Foundational Stds

8. © CDISC 2015 8 TA standards released in 2014-2015 : Multiple Sclerosis Diabetes Cardiovascular Influenza QT Studies Chronic Hep-C Schizophrenia Dyslipidemia Upcoming by Dec 2015: Breast Cancer Traumatic Brain Injury COPD Diabetes (ADaM Supplement) Virology v2

9. © CDISC 2015 CFAST Pipeline 9 Projects in Bold have been completed / published

10. © CDISC 2015 SHARE Road Map: Incremental Implementation 10 R1 Q1 2014 R2 Q4 2014 R3 Q4 2015 R4 Q4 2016 Major Versions: Releases 1 - 4

11. © CDISC 2015 R3: End-to-End Standards Model R1 Theme: Machine-Readable Standards R2 Theme: SHARE Concept Model R3 Theme: End-to-End Standards Model R4 Theme: Multiple Concept Systems 11 R3 Q4 2015

12. © CDISC 2015 SHARE and Therapeutic Area Standards Development TA Standards Available: Asthma Alzheimer's Virology Cardiovascular Diabetes Influenza Dyslipidemia Future: TA Standards Prostate Cancer development pilot Specification documents generated from SHARE Metadata  CDASH, SDTM, & ADaM Examples Biomedical Concepts Diff files 12

13. © CDISC 2015 Early Examples of Demonstrated Value "Before the variables of the SDTM-IG were published electronically in eSHARE, it took me all my evenings during two weeks to copy and paste the information from a new SDTM-IG into my SDTM-ETL mapping software. After the variables were published in eSHARE as a worksheet, it took me just 2 hours.” "Once CDISC publishes the variables of the SDTM-IG as a Define-XML template, it will take me 2 minutes." 13

14. © CDISC 2015 SHARE API Program Programmatic access to SHARE content Targeted at vendors and MDR implementations  Allows vendors to offer seamless SHARE integration  Allows MDR users to pull automated updates IMI eTRIKS implementing also Aim to eliminate the need to manually load standards content into MDRs and other software Will require additions to the SHARE technical and support infrastructure 14

15. © CDISC 2015 Keep up with eSHARE News Periodically check the website  http://cdisc.org/cdisc-share http://cdisc.org/cdisc-share CDISC Newsletter Follow our Social Media:  Twitter: follow @CDISC, @cdiscSHARE, @swhume  LinkedIn Group: CDISC  CDISC Facebook Group SHARE space on the CDISC Wiki  http://wiki.cdisc.org http://wiki.cdisc.org Sam’s blog on SHARE topics  http://mungingmetadata.blogspot.com/ http://mungingmetadata.blogspot.com/ 15

16. © CDISC 2015 European Activity Modus operandi established between EMA and CDISC Leadership, monthly calls MOU with IMI – eTRIKS & Biovacsafe projects, EHR4CR CTR in public review Vaccines standard public review 2 nd quarter 2016 Exploring fit of new EU CT Portal with CDISC standards EMA rep on CFAST Scientific Advisory Committee Staff hires – John Owen (Therapeutic Area Standards), Dorina Bratfalean (Data Management expert), Paul Houston, Sue Smith - secretariat function. Relaunch of CDISC UK Network, Italian coming... CDISC day Warsaw, 2016 Interchange Vienna

17. © CDISC 2015 Schema components Based on CDISC ODM 1.3.2 Extended with the existing SDM-XML 1.0 (Study Design Model in XML) Especially for Trial Parameters (sdm:Parameter) Additional elements for common CT.gov-EudraCT-WHO content, not already covered by ODM For very specific Eudra-CT content, incorporation of two Eudra-CT XML-Schemas 17

18. © CDISC 2015 What can it be used for? Software vendors can develop software that provides a “develop once, submit multiple” solution, i.e. One software tool for generating CTR submissions to as well ClinicalTrials.gov as to Eudra-CT as to … Starting from scratch or from an existing Study Design in ODM Improve beginning to end integrity of data with extended protocol elements and SDM elements 18

19. © CDISC 2015 PROTOCOL pieces and projects 19

20. © CDISC 2015 20 Project ‘Optimus’ as a second stage of CDISC CTR will focus on defining fully structured protocol and results summary elements. The CTR2 standard will therefore utilize and necessitate the development of a new Protocol standard – PRIMe. The goal of the new standards being: driving further harmonisation of International Registry requirements between stakeholders to advance the beginning to end support of clinical trials Ensure that IDMP elements are mapped to CTR2 and PRIMe CTR 2 Protocol Representation Implementation Model - executable Clinical Trial Registration & Results 2 PRIMe Project Optimus - Project Goals

21. © CDISC 2015 PRIMe & CTR2 Combined drivers Achieve true beginning to end support of clinical trial elements Create great efficiencies within development programs using CDISC standards Easier reuse of trial designs Data quality gains through information management improvements Enabling re-use of content IDMP(ISO Identification of Medicinal Products) inclusion to increase the depth and quality of information relating to medicinal products, substances etc Support better Pharmacovigilance and research Effective searching against clinical trial databases etc…

22. © CDISC 2015 Registration Now Open for the CDISC Day in Warsaw Join us in Warsaw, Poland on 19 February 2016 to learn about CDISC. This one-day event will cover important CDISC topics such as:  CDISC Standards and Implementation Experiences  CDISC/CFAST Therapeutic Area Standards  SHARE Metadata Repository  CDISC Education and Collaborations in Europe, e.g. IMI and EMA  2016 CDISC Europe Interchange View the preliminary agenda. Seats are limited, register by 15 February! Click here to register and pay by credit card Click here to register and pay by invoice Interested in increasing the visibility of your company? Take advantage of CDISC sponsorship opportunities. Contact dharakeh@cdisc.org for more information. ​preliminary agenda Click here to register and pay by credit card Click here to register and pay by invoicedharakeh@cdisc.org

23. © CDISC 2015 CDISC Interchange in 2016 23 www.cdisc.orgwww.cdisc.org/Events Abstracts: Call for abstracts is now open. Deadline: 4 January 2016 Submit your abstract today!

24. © CDISC 2015 October 2016 – CDISC 2 day Workshop at EBI + SHARE/TA day 24 2 day Clinical Research Advancements Workshop – 19 th -20th CDISC Day –Therapeutic Areas & SHARE - 21 st October