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INTRODUCTION TO CDISC

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. INTRODUCTION TO CDISC What is CDISC?. What is CDISC A world of Standards CDISC in submission What Next.

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INTRODUCTION TO CDISC

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  1. 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. INTRODUCTION TO CDISCWhat is CDISC? Whatis CDISC A world of Standards CDISC in submission WhatNext TheClinical 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. INTRODUCTION TO CDISCWhat is CDISC? Whatis CDISC A world of Standards CDISC in submission WhatNext The mission is to develop and support global, platform-independentdata standards that enable information system interoperability to improve medical research and related areas of healthcare.  http://www.cdisc.org/

  4. INTRODUCTION TO CDISCWhat is CDISC? Whatis CDISC A world of Standards CDISC in submission WhatNext • CDISC standards are: • vendor-neutraland platform-independent • freely available via the CDISC website • results of volunteer work in CDISC teams.

  5. INTRODUCTION TO CDISCWhat is CDISC? Whatis CDISC A world of Standards CDISC in submission WhatNext • 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

  6. INTRODUCTION TO CDISCWhat is CDISC? Whatis CDISC A world of Standards CDISC in submission WhatNext http://www.cdisc.org/interchange

  7. INTRODUCTION TO CDISCA World of Clinical Standards Whatis CDISC A world of Standards CDISC in submission WhatNext

  8. INTRODUCTION TO CDISCA World of Clinical Standards Whatis CDISC A world of Standards CDISC in submission WhatNext Source: P.-Y. Lastic, Sanofi

  9. INTRODUCTION TO CDISCA World of Clinical Standards Whatis CDISC A world of Standards CDISC in submission WhatNext The CDISC “Foundation Stone”

  10. 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 INTRODUCTION TO CDISCCDISC in Submission Whatis CDISC A world of Standards CDISC in submission WhatNext Study Data Technical Conformance Guide February 2014 http://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM384744.pdf

  11. INTRODUCTION TO CDISCCDISC in Submission Whatis CDISC A world of Standards CDISC in submission WhatNext

  12. INTRODUCTION TO CDISCWhat Next Whatis CDISC A world of Standards CDISC in submission WhatNext CDISC GANTT Chart

  13. INTRODUCTION TO CDISC Questions

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