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CDISC Standards Webinar Latest Updates and … · • Each course contains an exam. ... Interchange...
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CDISC Standards Webinar—Latest Updates and Additions 31 Jan 2013
Transcript of CDISC Standards Webinar Latest Updates and … · • Each course contains an exam. ... Interchange...
CDISC Standards Webinar—Latest Updates and Additions
31 Jan 2013
© CDISC 2013 2
CDASH-SAE Domains
CDISC CDASH – SAE Team Update
Rhonda Facile, CDISC
Gary Walker, Quintiles
© CDISC 2013
Agenda
• Background
• Mapping CDASH to E2B
• New Domains and Variables
• Timeline to publication
• Acknowledgements
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© CDISC 2013
Background
• The project started in 2010
• Initiative sponsors:
Barry Burnstead, Rhonda Facile
• Initial goal was to identify and describe the E2B
fields that are collected at investigational sites.
• ‘CDASH-E2B team’ officially formed
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© CDISC 2013
CDASH-E2B: Why?
• Reporting serious adverse events (SAEs) to
regulatory bodies in a timely manner during the
course of a clinical study is critical for Sponsors.
• However, in most cases, clinical data is not
captured in line with the E2B industry safety
standard, leading to a disconnect between clinical
and safety databases.
• CDASH being the first standard applied to clinical
data at point of capture needs to take account of
all data requirements and destinations.
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© CDISC 2013
Our Goals
• To eliminate duplication of data collection
“enter data once”, use when and where needed
• To provide the needed (and standardised)
metadata that will assist and support drug safety in
meeting regulatory reporting requirements
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© CDISC 2013
Mapping E2B to CDASH fields
• E2B R2 vs. CDASH 1.1
© CDISC 2013
Gap Analysis
A total of 235 E2B fields have been identified.
• 150 fields are not typically collected at site or
do not have a CDASH identity
16 fields could/should be known or collected
• eg, causality assessment, reporter comments,
country where the event occurred
• 85 fields are collected at site
68 fields already have CDASH identity
19 fields need a CDASH identity developed
• primarily regarding Parent and Death areas
© CDISC 2013
New Domains and Variables
• New CDASH identities recommended for the
35 identified ‘gap’ fields
Additional 15 identified during the F2F Meeting
• New SAE CDASH domain recommended
• SAE Addendum to CDASH being drafted
• Fields currently excluded from the CDASH-E2B
mapping will be reviewed in future versions
Investigator provides information through a single interface. (“combo form”, linked forms,
conditional forms)
Research Database
Sponsor Safety Database
SAE Domain SAE Form Data
All relevant clinical and related information including patient characteristics, therapy details, medical history,
clinical course of the event, laboratory evidence and any other information that supports or refutes causality.
Submit study data in SDTM format to
regulators as needed.
Report in E2B format to Health Authorities and other
recipients in required timeframe
CDASH Data Elements DM, CM, MH, etc.
CRF Domains data
CDASH Data Elements: AE Domain AE CRF Data
CDASH Data Elements DM, CM, MH, etc.
CRF Domains data
CDASH Data Elements: AE Domain AE CRF Data
© CDISC 2013
Examples of SAE domain data not
already collected in CDASH
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CDASH SAE-specific variables • SAERPTRFNM (SAE reporter’s family name)
• ICSRID (Sender’s safety case report unique ID)
Subject data that could map to SDTM domains • AUCDTH
(DDORRES when DDTEST=“Autopsy determined cause of death”)
•AUPERF
(PROCCUR when PRTERM=“Autopsy”)
Data for “Associated Persons” that could map to SDTM domains • APDM.AGE
(APDM.AGE when DMRELSUB = “Father, Biological”)
•APMH.MHTERM
(APMH.MHTERM when MHRELSUM = “Father, Biological”)
© CDISC 2013
TENTATIVE TIMELINE TO PUBLICATION
• Submit to SRC for approval to post for public
comment (February)
• Public review (March)
• Submit to SRC for approval to publish (April)
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Harmonized Version
Initial Consensus
Version
Reviewed Version
Released(Production)
Version (1.0)
TLC Review
CDISC InternalReview
Public Review
Testing
comments addressed by team
OKOK
SRC Review (For approval to post for public
review)
© CDISC 2013
CDASH-E2B Team Name Region Affiliation Email Address
Gary Walker US Quintiles [email protected]
Barry Burnstead EU Select CRO [email protected]
Lauren Shinaberry EU Business & Decision Life
Sciences
Sonia Araujo EU Medidata Solutions [email protected]
Sean Neak EU Medidata Solutions [email protected]
Roland Franke EU PRA International [email protected]
Tracy Sanders US Foresight Group [email protected]
Ling Chin, MD, MPH US Consultant, GCP Clinical
Trials
Monica Mattson US Celgene [email protected]
Shannon Labout US CDISC [email protected]
Rhonda Facile US CDISC [email protected]
© CDISC 2012
CDISC Online Training
Saad Yousef, CDISC
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© CDISC 2012
Online Courses coming soon!
• Courses split into modules
• Technical and Therapeutic Area courses will be
offered
TA courses offered online only
Technical courses still offered via public and private
training
• First few modules to be available in early
February.
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© CDISC 2012
How to sign up?
• Each registrant must create account by going to
http://CDISC.trainingcampus.net
• Same discounts available for GOLD (20%) and
PLATINUM (40%) members. Discount codes are
case sensitive.
• Each course contains an exam. Certificates
available for passing candidates (automatic).
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© CDISC 2012
Advantages/Disadvantages
• Advantages
Take courses from comfort of own office/home
Self-paced
Automatic certificate after test successfully passed
• Disadvantages
No opportunity for discussion or to ask questions to
an instructor
• Still have option of signing up for public and private
courses. Click here for more info.
No opportunity to network with others had you
registered for public course offering.
• Click here for public course offering.
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© CDISC 2012
Questions?
• Please start sending in questions pertaining to
CDASH-SAE or CDISC Online Training.
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© CDISC 2012
CDISC
Education and Communications Updates
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Presented by: Saad Yousef, CDISC, Associate of Education and Operations
© CDISC 2012
Read the Latest CDISC News
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• Join our e-mail list www.cdisc.org
• Read our monthly e-Newsletter
• See the CDISC home page: www.cdisc.org for all current events
• Read our Blogs: http://www.cdisc.org/cdisc-blog
• Follow us on social media!
© CDISC 2012
What’s New on the CDISC Website
• Subscribe to RSS Feeds
• Clear and easy display of the CDISC Standards
and Innovations http://www.cdisc.org/standards
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© CDISC 2012
What’s New on the CDISC Website
• Rotating Banner at the bottom of the Home page
and the Newsletter page to value our Platinum
Members www.cdisc.org
© CDISC 2012
Inaugural Asia-Pacific Interchange
© CDISC 2012
Interchange Details
• Asia-Pacific Interchange in Singapore, 18-22 Feb 2013
Deadline to register is 8 Feb 2013
Sponsorship opportunities available
Education courses offered: ADaM, CDASH, Controlled
Terminology, and SDTM
http://www.cdisc.org/interchange
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© CDISC 2012
CDISC European Interchange - 2013
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© CDISC 2012
Interchange Details
• Europe Interchange in Germany, 22-26 April 2013
Registration is now open
Sponsorship opportunities available
Education courses offered: ADaM, BRIDG Deep Dive, CDASH,
Controlled Terminology, ODM, and SDTM
http://www.cdisc.org/interchange
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© CDISC 2012
Other Public Education Opportunities
• Morrisville, NC from 12-15 February 2013
• South San Francisco, CA from 5-8 March 2013
• St. Louis, MO from 21-24 May 2013
• Cambridge, MA on 17 July 2013
• Full schedule and registration at www.cdisc.org/public-training-courses
Early registration discounts available for select public training events.
Please click on the above link to access event registration details.
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© CDISC 2012
CDISC In-House Education
• Schedule in-house authorized CDISC education for
your company - designed to meet your CDISC
education needs.
• For more information:
Visit our website www.cdisc.org/private-training
or fill out private education request form found here (form can
also be found at above webpage).
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© CDISC 2012
CDISC Authorized Instructors
Find out who our
instructors are at
www.CDISC.org
© CDISC 2012
Upcoming CDISC Webinars
• Watch for more CDISC Team Updates and other topics
in our Webinar Series in the coming months
• CDISC Webinar schedule published at:
www.cdisc.org/webinars
• Next webinar is scheduled for 7 March 2013. Visit the
CDISC website (link above) for info on next year’s
webinars.
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© CDISC 2012
Get Involved!
• Become a CDISC Member
• Participate in Public Reviews
• Attend the Interchanges and authorized training
• Be a key collaborator
• Adopt the standards—ask partners to do so
• Spread the word
• Volunteer
For more information about CDISC
please visit our website:
www.cdisc.org
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© CDISC 2012
CDISC’s vision is to:
Inform Patient Care & Safety Through Higher Quality Medical Research
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Any more questions?
Thank you for attending this webinar.
