CDISC Advisory Council (CAC) Teleconference

Wednesday – 09 March, 2016

11:00 am – 12:30 pm (US Eastern Time)

Topic / Notes
Welcome CAC Members
Sue Dubman – CAC Chair / Sue welcomed the CAC Members and asked attendees to sign in online or let Sheila Leaman knowthey are at the meeting so an attendee list can be prepared.
Vote for your CAC Board Committee Representatives
Jonathan Chainey – CAC Chair-Elect / Jonathan thanked the representatives who have been nominated to serve on the various CAC Board Committees. The Executive Committee has approved the following nominees:
Strategy Committee
  1. Nina Worden – Santen, Inc.
  2. Yoshiro Aoyagi – National Cancer Center
  3. Brooke Hinkson – Merck & Company
  4. Scott Getzin – Eli Lilly
Technical Committee
  1. Praveen Garg– AstraZeneca
Finance Committee
  1. Trisha Simpson –UCB
Jonathan urged all to vote, even in the categories where there is only one nominee.
Action:
-All CAC Members – Vote for the Board Committee Representative by 30 March 2016.
-Sheila will set up voting mechanism and send the link
Meet CDISC VP, Standards, Terminology andTechnical Services - Barrie Nelson
– Main area offocus / Jonathan introduced Barrie Nelson who recently joined CDISC as the VP of Standards, Terminology andTechnical Services. Barrie provided a background of his experience including over 13 years volunteering for CDISC. He then presented CDISC’s new delivery plan for CDISC Standards,Terminology and Technical Serviceswhich was developed as a result of feedback from CDISC’s Listening Tours with several member organizations. The plan reflects CDISC’s desire to encourage the team to work on
collaborative efforts with increased transparency.
Q: What are the specific projects to ensure end-to-end standards development?
A: Enhanced collaboration among teams, harmonization among standards as we put together a comprehensive package. Representing all standards content in SHARE, which will allows us to betterdefine relationships among standards. End-to-end standards development is a broad, difficult goal; CDISC is looking for ideas from the CAC and welcomes your feedback.
Q: Is there any new guidance regarding how to model questionnaires?
A: This is an important area for discussion. Please forward specific concerns and/or examples to Barrie () and he will SHARE with the QRS Team.
Q: Regarding end-to-end standards development, are you also looking for technical solutions?
A: We will use SHARE capabilities to instantiate relationshipsbetween the standards. Additionally, biomedical concepts will connect related points in standards and constrain related controlled terminology.
Q: Please expand on enhancements to Controlled Terminology.
A: We want to provide transparency in the Terminology requests by providing regular updates as to where the terms are in the process. We will be using Jira, the issue tracking software for this initiative.
Q: Is there a contact we can check with to see where a request currently is in the process?
A: Barrie will check about this and inform the group.
Brief Overview on CDISC Accomplishment
Nicole Harmon –Chief Operating Officer, CDISC / Nicole presented CDISC Key Accomplishments in 2015. She also relayed the recent success of our first fundraiser, Cowboy Up, which raised funds and awareness around PTS and Traumatic Brain Injury. Nicole thanked our sponsors The Golden Rule Family Foundation, the Association of the US Army, and Quintiles.
Update on SHARE – SHARE Steering Committee
Michael Ibara –Head of Digital Healthcare, CDISC / Michael discussed SHARE and Healthcare Link. He informed the group that SHARE is a highly curated metadata repository to
support computable CDISC standards. Curating information in SHARE is an intensive and ongoing process; similar to programming a computer. He added that we need to get Biomedical Concepts to agree and be highly defined so that they work together. He acknowledged that each organization has its own Biomedical Concepts and that CDISC is working on a strategy for how these concepts are developed. In the end, users will have computable standards to ensure computer to computer sharing of information, eliminating rework. Michael also discussed how the API (to be released in June or July of 2016) will allow information in SHARE to be shared with other metadata repositories, eliminating rework and reuse.
CDISC is concentrating on specific standards from the Oncology Prostate Therapeutic Area, which will be developed in SHARE, to serve as a template to refine the process.
Regarding Healthcare Link, CDISC was awarded a grant to look at eSource (electronic source of information) using electronic health records (EHR) to support regulated trials. First meeting of eSource Regulators group will take place at the Intrachange in mid-March.
CAC Face-to-Face Meeting in April – Call for Input on discussion items
Jonathan Chainey – CAC Chair-Elect / CDISC Board Member, Steve Pyke, will lead the CAC face-to-face meeting on Tuesday, 26 April inVienna during the Europe Interchange as Sue and Jonathan will not be able to attend. The CDISC Board andregulators willbe joining the meeting.
Action: Sheila will send out an invitation at the end of March. Face-to-Face Meeting schedule:
3:30 – 4:00 pm Networking Tea
4:00 – 6:00 pm Meeting
Action: Sheila encouraged CAC representatives to come with questions or send them to her ()beforehand to ensure active participation.
CDISC Intrachange in March
Rhonda Facile – VP, Standards Development, CDISC / Rhonda encouraged the group to register for the March Intrachange if they haven’t already done so. She announced that CDISC is making significant changes to the event in light of feedback received from recent Listening Tours. For example, we have cut back plenary sessions to only one. We will focus more on cross-team collaboration. The key message is :
“Everything is Related to Everything.”
Program Planning Committee for the September 2016 International Interchange
Sheila Leaman – Director of Global Relations, CDISC / Sheila announced that8CAC members have signed up for the Program Planning Committee and thanked them for volunteering.
Action: If you are interestedin joining the Program Planning Committee, please contact Sheila ().
The Call for Abstractsfor the International Interchange has been sent out and the deadline for receiving these abstracts is April 8.
Action: Sheila will send the link in the meeting minutes.
Any Other Business
Sue Dubman / Action: Sue and Sheila asked the group to send topics they are interested in, for future CAC Teleconferences, and/or ideas for presentations.

CAC Member Attendee List

Member Name / CAC Representative
Accenture / Kenneth M. Stoltzfus
AKANA / Dan Ringenbach
Alexion Pharmaceuticals / SonaliGarg
Joan Berger
Amgen / Shannen McGinnis
AstraZeneca / Praveen Garg
BioClinica, Inc. / Jennifer Price
BoehringerIngelheim Pharmaceuticals / Sharon Marmaras
Bristol Myers Squibb / Richard Perry
Celgene Corporation / Monica Mattson
Center for Biostatistics in AIDS Research / Heather Ribaudo
Chiltern / Mark Penniston
CompleWare Corporation / Michael Wright
Computer Sciences Corporation / SrinivasaRaoMandava
Critical Path Institute / Enrique Aviles
d-Wise Technologies / Tom Kalfas
Eisai, Inc. / William Standen (Will)
Eli Lilly and Company / Scott Getzin
F. Hoffmann-La Roche Ltd / Jonathan Chainey
Forte Research Systems, Inc. / Shannon Roznoski
Gilead Sciences / Gregory Campbell
IBM / Nancy Friedland
inVentiv Health Clinical, LLC / Paul Slagle
Johnson & Johnson / Patrick Genyn
Lung R&D Clinical / Maggie Lo
McDougall Scientific Ltd. / Hong Chen
Medtronic, Inc. / Paul Francson
Merck & Co., Inc. / Brooke Hinkson
Merck KGaA / Markus Stoll
National Cancer Center / Yoshihiro Aoyagi
National Cancer Institute / Erin Muhlbradt
New York University School of Medicine / Alexander Bragat
Novartis Pharmaceuticals Corporation / AparnaKulkarni
Parexel International / BenediktEgersdoerfer
Pfizer / Unnat Patel
Pinnacle 21, Inc. / Max Kanevsky
PRA International / Kent Letourneau
Premier Research Group / Trish Rice
Quality Data Services, Inc. / EllinaBabouchkina
Quantum Leap / Sue Dubman
Santen, Inc. / Jeanina Worden
SCRI Development Innovations / David Moorman
SAS Institute, Inc. / Bill Gibson
SGS Life Sciences Services / TinekeCallant
Shire Pharmaceuticals, Inc. / Diane Piper
Takeda Pharmaceuticals Interntional Co. / Elizabeth Langevin
Target Health / Yong Joong Kim
CDISC / Rhonda Facile
Nicole Harmon
Michael Ibara
Sheila Leaman
Barrie Nelson
Ann White

NOTE : Please excuse us if we have missed your name on the list.