INTRODUCTION TO CDISC - ssfa.it · PDF fileGeneva Branch INTRODUCTION TO CDISC Biometristi...
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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
Transcript of INTRODUCTION TO CDISC - ssfa.it · PDF fileGeneva Branch INTRODUCTION TO CDISC Biometristi...
Geneva Branch
INTRODUCTION TO CDISC
Biometristi Italiani Associati – Seminario BIASCDISC SDTM and ADaM: Moving from theory to practiceSAS Institute – Milano - 14/03/2014
BIAS Committe
Geneva Branch
BIAS Committee 2
INTRODUCTION TO CDISCWhat is CDISC?
What is CDISC
A world of Standards
CDISC in submission
What NextThe Clinical Data Interchange StandardsConsortium (CDISC) is a global, open,multidisciplinary, not-for-profit organization thathas established standards to support theacquisition, exchange, submission and archive ofclinical research data and metadata.
Geneva Branch
BIAS Committee 3
INTRODUCTION TO CDISCWhat 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 thatenable information system interoperability toimprove medical research and related areas ofhealthcare.
http://www.cdisc.org/
Geneva Branch
BIAS Committee 4
INTRODUCTION TO CDISCWhat is CDISC?
What is CDISC
A world of Standards
CDISC in submission
What NextCDISC standards are:• vendor-neutral and platform-independent• freely available via the CDISC website• results of volunteer work in CDISC teams.
Geneva Branch
BIAS Committee 5
INTRODUCTION TO CDISCWhat 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
Geneva Branch
BIAS Committee 6
INTRODUCTION TO CDISCWhat is CDISC?
What is CDISC
A world of Standards
CDISC in submission
What Next
http://www.cdisc.org/interchange
Geneva Branch
BIAS Committee 7
INTRODUCTION TO CDISCA World of Clinical Standards
What is CDISC
A world of Standards
CDISC in submission
What Next
Geneva Branch
BIAS Committee 8
8 Source: P.-Y. Lastic, Sanofi
INTRODUCTION TO CDISCA World of Clinical Standards
What is CDISC
A world of Standards
CDISC in submission
What Next
Geneva Branch
BIAS Committee 9
INTRODUCTION TO CDISCA World of Clinical Standards
The CDISC “Foundation Stone”
What is CDISC
A world of Standards
CDISC in submission
What Next
Geneva Branch
BIAS Committee 10
INTRODUCTION TO CDISCCDISC 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 GuideFebruary 2014http://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM384744.pdf
What is CDISC
A world of Standards
CDISC in submission
What Next
Geneva Branch
BIAS Committee 11
INTRODUCTION TO CDISCCDISC in Submission
What is CDISC
A world of Standards
CDISC in submission
What Next
Geneva Branch
BIAS Committee 12
INTRODUCTION TO CDISCWhat Next
CDISC GANTT ChartWhat is CDISC
A world of Standards
CDISC in submission
What Next
Geneva Branch
BIAS Committee 13
INTRODUCTION TO CDISC
Questions
