1. Geneva Branch INTRODUCTION TO CDISC Biometristi Italiani Associati – Seminario BIAS CDISC SDTM and ADaM: Moving from theory to practice SAS Institute – Milano - 14/03/2014 BIAS Committe

2. Geneva Branch BIAS Committee 2 INTRODUCTION TO CDISC What is CDISC? What is CDISC A world of Standards CDISC in submission What Next The Clinical Data Interchange Standards Consortium (CDISC) is a global, open, multidisciplinary, not-for-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata.

3. Geneva Branch BIAS Committee 3 INTRODUCTION TO CDISC What is CDISC? What is CDISC A world of Standards CDISC in submission What Next The 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. http://www.cdisc.org/

4. Geneva Branch BIAS Committee 4 INTRODUCTION TO CDISC What is CDISC? What is CDISC A world of Standards CDISC in submission What Next CDISC standards are: vendor-neutral and platform-independent freely available via the CDISC website results of volunteer work in CDISC teams.

5. Geneva Branch BIAS Committee 5 INTRODUCTION TO CDISC What is CDISC? CDISC  Started in 1997  By 2014 it has been sponsored by +200 members including:  Pharma and biotech companies  CROs and specialized vendors  Medical device companies  Not-for-profit, academic organizations What is CDISC A world of Standards CDISC in submission What Next

6. Geneva Branch BIAS Committee 6 INTRODUCTION TO CDISC What is CDISC? What is CDISC A world of Standards CDISC in submission What Next http://www.cdisc.org/interchange

7. Geneva Branch BIAS Committee 7 INTRODUCTION TO CDISC A World of Clinical Standards What is CDISC A world of Standards CDISC in submission What Next

8. Geneva Branch BIAS Committee 8 8 Source: P.-Y. Lastic, Sanofi INTRODUCTION TO CDISC A World of Clinical Standards What is CDISC A world of Standards CDISC in submission What Next

9. Geneva Branch BIAS Committee 9 INTRODUCTION TO CDISC A World of Clinical Standards The CDISC “Foundation Stone” What is CDISC A world of Standards CDISC in submission What Next

10. Geneva Branch BIAS Committee 10 INTRODUCTION TO CDISC CDISC in Submission Prescription Drug User Fee Act (PDUFA) Timeline  —Dec 2012 – Draft Guidance on standards and format of eSub  + 12 Months – Final Guidance released  + 36 Months – All new NDAs/BLAs to use CDISC End 2015 / 2016 no more an option Study Data Technical Conformance Guide February 2014 http://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM384744.pdf What is CDISC A world of Standards CDISC in submission What Next

11. Geneva Branch BIAS Committee 11 INTRODUCTION TO CDISC CDISC in Submission What is CDISC A world of Standards CDISC in submission What Next

12. Geneva Branch BIAS Committee 12 INTRODUCTION TO CDISC What Next CDISC GANTT Chart What is CDISC A world of Standards CDISC in submission What Next

13. Geneva Branch BIAS Committee 13 INTRODUCTION TO CDISC Questions