Transcript Document

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
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BIAS Committee
INTRODUCTION TO CDISC
What is CDISC?
Geneva Branch
What is CDISC
A world of Standards
CDISC in submission
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.
What Next
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BIAS Committee
INTRODUCTION TO CDISC
What is CDISC?
Geneva Branch
What is CDISC
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/
A world of Standards
CDISC in submission
What Next
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BIAS Committee
INTRODUCTION TO CDISC
What is CDISC?
Geneva Branch
What is CDISC
A world of Standards
CDISC standards are:
• vendor-neutral and platform-independent
• freely available via the CDISC website
• results of volunteer work in CDISC teams.
CDISC in submission
What Next
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BIAS Committee
INTRODUCTION TO CDISC
What is CDISC?
Geneva Branch
What is CDISC
CDISC
A world of Standards
CDISC in submission
 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 Next
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BIAS Committee
INTRODUCTION TO CDISC
What is CDISC?
Geneva Branch
What is CDISC
A world of Standards
CDISC in submission
What Next
http://www.cdisc.org/interchange
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BIAS Committee
INTRODUCTION TO CDISC
A World of Clinical Standards
Geneva Branch
What is CDISC
A world of Standards
CDISC in submission
What Next
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BIAS Committee
INTRODUCTION TO CDISC
A World of Clinical Standards
Geneva Branch
What is CDISC
A world of Standards
CDISC in submission
What Next
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Source: P.-Y. Lastic, Sanofi
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BIAS Committee
INTRODUCTION TO CDISC
A World of Clinical Standards
Geneva Branch
What is CDISC
The CDISC “Foundation Stone”
A world of Standards
CDISC in submission
What Next
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BIAS Committee
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
Geneva Branch
What is CDISC
A world of Standards
CDISC in submission
What Next
11
BIAS Committee
INTRODUCTION TO CDISC
CDISC in Submission
Geneva Branch
What is CDISC
A world of Standards
CDISC in submission
What Next
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BIAS Committee
INTRODUCTION TO CDISC
What Next
CDISC GANTT Chart
Geneva Branch
What is CDISC
A world of Standards
CDISC in submission
What Next
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BIAS Committee
INTRODUCTION TO CDISC
Geneva Branch
Questions