Vaccines Project Snapshot
Project Mission
Status
Ensure a consistent use and development of
the CDISC standards
for use in vaccines studies, intended to
support regulatory submissions, across all
diseases/Vaccines preventable diseases
areas in all age groups.
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Main project = stepwise work by topic
On current topic: reactogenicity SDTM model
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Next steps: finalise SDTM + terms, CDASH, ADaM
Next topics: lab data (Immunogenicity, safety) – not
started yet
Project Scope
Full Team Members – AE subteam
Vaccines User Guide,
CDASH, SDTM, ADaM standards and Controlled
Terminology
Iterative work by topic: piecewise development of guides
Current topic is reactogenicity (SDTM + terminology) for v1.0
1. Define requirements.
2. Develop guidelines.
3. Elaborate and submit proposals for extension/update of
these standards to the related CDISC teams (Terminology,
SDTM Gov. Committee, CDASH, ADaM).
4. Interact with and provide feedback to other teams.
© CDISC 2015
Frances M. Acton (Merck&Co)
Brenda Baldwin (FDA CBER)
Anne-Sophie Bekx (BDLS)
Karin Botilde (GSK)
Dorina Bratfalean (CDISC)
Xavier Cornen (SanofiPasteur-MSD)
Cedric Davister (GSK)
Pamela Freese (Pfizer)
Audrey Hagenbach (Sanofi-Pasteur)
Christian Hoppe (Charite)
Paul Houston (CDISC)
Ragini Khedoe (GSK)
Veronique Long (Sanofi-Pasteur)
Dave O’Riordan (GSK)
John Owen (CDISC)
John Perez (Pfizer)
Kirk Prutzman (FDA CBER)
Barbara Rath MD PhD (Charite)
Magali Savoy (Sanofi-Pasteur)
Ramana Setty (Sanofi-Pasteur)
Olive Yuan (Johnson&Johnson)
Elodie Zaworski (Sanofi-Pasteur)
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Traditional Chinese Medicine-Acupuncture
Project Snapshot
Project Mission
Develop a v1.0 CDISC Acupuncture
Therapeutic Area User Guide (TAUG)
using the most common acupuncture
concepts.
Project Launched in Q2 2015
Status
Stage 0 – Focus on understanding
acupuncture concepts and prepare proposal
Project Scope
Team Members
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•Wen Zehuai
•Xiaoyan Li – Key Unit of Methodology in Clinical Research
(KUMCR) Guangdong
•Geng Li –KUMCR Guangdong
•Zibao Zhang – PPDI
•Jordan Li – NCI-EVS
•Erin Muhlbradt – NCI-EVS
•Rebecca Kush – CDISC
•Rhonda Facile – CDISC
•Alana St. Clair – CDISC
•Sheila Leaman – CDISC
•Anthony Chow – CDISC
Core acupuncture concepts
CDASH and SDTM
Terminology
Analysis guidelines
© CDISC 2015
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Nutrition Project Snapshot
Project Mission
Ensure the consistent use of existing
CDISC standards for clinical research in
nutrition, and to facilitate alignment and
development of new standards for
research in all areas and for all life-stages
in nutrition.
Project Launched in Q1 2015
Status
Stage 0 – Focus on Charter, TA Survey,
building concept list
Project Scope
Team Members
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Core nutrition concepts
SDTM
CDASH
Terminology
CDISC TAUG
© CDISC 2015
Simon Lebeau – Ividata/Danone Research
Hanneke Lankheet – Danone Nutricia Research
Emilie Ba – Nestlé
Elsbeth Verdonk – Danone Nutricia Research
Johan Schilt – Unilever
Stephane Auger – Danone Research
Fabien Foltzer – Nestlé
Geraldine Baggs – Abbott Nutrition
Sue Zhang – Abbott Nutrition
LuAnn Hitzemann – Abbott Nutrition
Anna Lyra – DuPont Nutrition & Health
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Malaria Project Snapshot
Project Mission
Ensure the consistent use of existing
CDISC standards for clinical research in
malaria, and to facilitate alignment and
development of new standards to ensure
a standard method of recording, storing
and reporting of clinical malaria data.
Project Launched in Q1 2015
Status
Stage 2
Project Scope
Team Members
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Core malaria diagnosis and treatment
concepts
SDTM
CDASH
Terminology
CDISC TAUG
© CDISC 2015
Lesley Workman – WWARN
Philippe Guerin – WWARN
Diane Wold – CDISC
Carolyn Famatiga-Fay – CDISC Fellow
Christine Fleeman – UCB, CDISC Fellow
Linda Kililani – UCB
Trisha Simpson – UCB
Kamal Hamed – Novartis
Justin green – GSK
Stephan Chalon – MNV
Valerie Lameyre – Sanofi
Andrea Bosman – WHO
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Ebola Project Snapshot
Project Mission
Status
Ensure the consistent use of existing
CDISC standards for clinical research in
Ebolavirus Disease (EVD) research, and
to facilitate alignment and development of
new standards for research in all areas
and for all life-stages in EVD.
Project Launched in Q1 2015
Stage 0 – Focus on Charter, TA Survey,
building on concept list developed by WHO
and ISARIC EVD researchers
Project Scope
Team Members
Not yet finalized, but will include at least:
• EVD research concepts
• CDASH
• SDTM
• Terminology
• CDISC TAUG
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© CDISC 2015
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Shannon Labout – CDISC
Maura Kush – PharmaStat
Jon Neville – C-Path
Laura Merson – OUCRU
Lac Huynh Van Nhat – OUCRU
Tien Nguyen Thanh – OUCRU
Yves Claeys – ISARIC
Laura Butte – C-path
Carolyn Famatiga-Fay - CDISC
Fellow
Sarah McLaughlin – Biogen
Gail Carson – Nuffield
Department of Medicine
Gary Walker – Quintiles
Kristin Kelly – Accenture
Vicki Tifft – Clinical RM
Douglas Mayers – USAMRIID
Kim Truett – KCT Data
Theresa Ockershausen – Clinical
RM
Steve Wilson – FDA
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