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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. INTRODUCTION TO CDISC What is CDISC?. What is CDISC A world of Standards CDISC in submission What Next. - PowerPoint PPT Presentation
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INTRODUCTION TO CDISC
Biometristi Italiani Associati – Seminario BIASCDISC SDTM and ADaM: Moving from theory to practiceSAS Institute – Milano - 14/03/2014
BIAS Committe
BIAS Committee 2
INTRODUCTION TO CDISC
What is CDISC?What is CDISC
A world of Standards
CDISC in submission
What NextThe 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.
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/
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.
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
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
BIAS Committee 7
INTRODUCTION TO CDISC
A World of Clinical StandardsWhat is CDISC
A world of Standards
CDISC in submission
What Next
BIAS Committee 8
8 Source: P.-Y. Lastic, Sanofi
INTRODUCTION TO CDISC
A World of Clinical StandardsWhat is CDISC
A world of Standards
CDISC in submission
What Next
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
BIAS Committee 10
INTRODUCTION TO CDISC
CDISC in Submission
Prescription Drug User Fee Act (PDUFA)TimelineDec 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 2014http://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM384744.pdf
What is CDISC
A world of Standards
CDISC in submission
What Next
BIAS Committee 11
INTRODUCTION TO CDISC
CDISC in SubmissionWhat is CDISC
A world of Standards
CDISC in submission
What Next
BIAS Committee 12
INTRODUCTION TO CDISC
What Next
CDISC GANTT ChartWhat is CDISC
A world of Standards
CDISC in submission
What Next
BIAS Committee 13
INTRODUCTION TO CDISC
Questions
