CDISC Advisory Council (CAC)

Teleconference, Wednesday–20 January 2016

11:00 am – 12:30 pm (US Eastern Time)

MINUTES

Topic / Notes
Welcome CAC Members
(Jonathan Chainey) / Chair Sue Dubman was unable to attend; Chair-elect Jonathan Chainey led the call.
Introducing Stephen Pyke, CDISC Board Member
(Jonathan Chainey) / Jonathan welcomed new Board Chair-Elect, Steve Pyke. Steve plans on attending most of the CAC meetings to listen in and understand what is important to the CAC member companies and to represent these views to the CDISC Board.
Update on CDISC Board of Directors January Meeting
(Steve Pyke & Nicole Harmon) / We welcomedSteve Pyke’sre-election to the CDISC Board of Directors and Jonathan Chainey as the CAC Board-elect. New Board Members includeMargaret Keegan, President, Data Sciences, Safety and Regulatory at Quintilesand Dr. Hiro Shirasawa,VP, Pharmaceutical Professional in Global Development and Medical Affairs at Merck in Japan.
There are 6 CDISC Board committees:
Executive Committee; Governance Committee (led by Pierre-Yves Lastic)
Technical Advisory Committee (led by Chuck Cooper)
Financial Oversight Committee (led by Doug Peddicord)
Strategy Committee (led by Jonathan Zung)
Fund Development Committee (led by Névine Zariffa), which is a new committee geared towards raising funds to progress strategic development and ensure sustainability of CDISC.
The last four committees have an opportunity for a seat by a CAC member.
Barrie Nelson will join CDISC on 29 January as VP of Standards, Terminology and Technical Services. Additionally, CDISC has hired a Director of Bioinformatics, who will start in March.
The 2016 Roadmap has been posted to the CDISC web site at Roadmap is a first draft and gives good guidance as to where CDISC is going. Steve welcomed feedback from the CAC membersto ensure the Roadmap communicates CDISC’s direction as itis still a work in progress.
Action: Review CDISC roadmap and give feedback to Dr. Nicole Harmon ().
  • Call for members to join the Planning Committee for the September 2016 International Interchange
  • (Jonathan Chainey)
/ Jonathan Chainey invited members to join the Program Planning Committee for the International Interchange which takes place 26-30 September in Bethesda. Commitment is monthly calls initiallyand more often as we get closer to the date of the event.
Action: If you are interested, please contact Sheila Leaman () by 15 February.
TA standards references in the FDA Standards Catalog
(Mary Ann Slack – FDA) / Mary Ann Slack began by sharing with the CAC thatthe representation of Therapeutic Area (TA) standards in the FDA Data Standards Catalog has been a hot topicof discussion at FDA. Since TA User Guides are not standards, the FDA has decided that, moving forward, SDTM versions that include the TA Standards, will be listed in the Catalog.
Support of TA standards will be captured in the Technical Conformance Guidance; a new guidance will be released in March 2016 and includeHepatitis C, QT Studies, Diabetes, and Dyslipidemia. Another Technical Conformance Guidance will be released by the end of 2016 and will include 10 TA standards.
FDA announced their support for SDTM 3.2, exclusive of TA standards because it came out before the TA standards were published. SDTM 3.3 and additional versions moving forward will be inclusive of TAs. FDA is planning on testing PGX, medical devices, and associated persons.
Q:Please clarify the FDA’s plans with ADaM?
A: We are figuring out requirements and will be working on recommendationonTA for ADaM type elements.
Q: SDTM 3.2 acceptance includes a disclaimer regarding domainsthatare not approved like DD and EC. Has there been any progress regarding those domains?
A: Yes. When we announced support for SDTM 3.2,we were still struggling withhow to accept TA and to determine procedure without domains at that time. Subsequently it was determined that would be fine, but do not have revised conformance guide, but should be supported within.
Q: Now that details are worked out, can FDA make an announcement through the CAC that STDM 3.2 is accepted?
A: I will make a note to announce this.
Q: With SDTM 3.3 in the works, is the FDA anticipating feedback to that before being published to ensure quick acceptance by the FDA?
A: There are part of reviews; it is a long process. We have made huge progress in our process and approach to review. We are trying to do review early in the process and hopefully not a long time before acceptance.
Q: Some companies are working to convert 3.1.2 to 3.2 version since it is fully accepted. However, if 3.3 is to be published and supported by FDA in six months or so, it may be worth converting from 3.1.2 to 3.3. So, planning and understanding the timeframe of how long it will take to review and test new standards in 3.3, even a guesstimate time will be very helpful. Others on the CAC seem to agree that this does affect a lot of us.
A: I will take this message back to the testing team to see if there is any reasonable degree of confidence in timeframe to walk through this when it comes out.
Q: Please address new standards version and their release dates.
A: When a new version is released, a date is included and organizations have one year from study start date to comply. It is the FDA’s objective tofacilitate fewer transitions of standards. That doesn’t mean you can’t submit data from an earlier version; we welcome that.
Q: Earlier is ok?
A: Yes, as long as we accept it. If you want to use something in advance of our support, by all means please reach out to us and let us know what your desire would be. Unless we find problems, we are happy to receive ‘required by date’ in the data standard catalog.
Q: How much does FDA plan to leverage SHARE for integrating your own environment with latest CDISC standards?
A: I can’t answer that, as we have our own clinical trialrepository. As standards come out, we want to ensure our own repository can support them. The FDA feels strongly that SHARE is really a roadmap of long-term sustainability and longevity of the standards. We support SHARE with grants to be able to see it realize its vision.
Board Committee Representatives nomination
(extended to 15 February) and their Roles
(Jonathan Chainey) / Jonathan encouraged CAC members to nominatesomeone who you feel would be an asset or you can self-nominate, to one of the 4 Board Committees – Financial Oversight (FOC), Strategy (CSC), Technical Advisory (TAC) and Fund Development. More information is available in ourCAC Announcement for end of 2015.
Action: Send a brief bio and short statementto Sheila Leaman () by 15 February
Fundraiser in Austin – PTS & Mental Health
(Nicole Harmon) / CDISC and One Mind for Research are hosting Cowboy Up! An Evening of Collaboration for PTS and Mental Health Research on March 3, 2016. We invite you to attend. We are grateful to our sponsors,the North Texas Chapter of the Army and Quintiles, and welcome additional sponsors. For more information, please visit
A press release about the Traumatic Brain Injury TA Standard will go out January 20.
2016 Schedule of CAC Meetings/Interchanges
(Sheila Leaman) / CDISC Intrachange: March 16 – 18, Bethesda, MD
European Interchange: April 25 – 29,Vienna, Austria
Program will be posted on the CDISC web site soon.
  • CAC Face-to-Face Meeting will be on Tuesday, April 26
3:30pm–4:00pm networking; 4:00pm–6:00pm meeting
Japan Interchange: May 30 – June 3, Tokyo, Japan
Registration will be on the CDISC web site next week.
International Interchange: September 26–30, Bethesda, MD.
  • CAC Face-to-Face Meeting will be on September 27
3:30pm – 4:00pm networking; 4:00pm – 6:00pm meeting
Any Other Business
(Jonathan Chainey) / CDISC has held several ‘Listening Tours’ with member companies to understand their implementation challenges. We are in the process of analyzing the results and will publish them in the 2nd quarter. These can potentially be shared with the CAC members by the next teleconference.
Action: Members are invited to share their feedback on implementation challenges with Nicole Harmon ().

CAC Attendees

Member Name / CAC Representative
Accenture / David Evans
AKANA / Julie Smiley
Alexion Pharmaceuticals / Sonali Garg
Amgen / Shannen McGinnis
AstraZeneca AB / Praveen Garg
Bayer Healthcare LLC / Susanne Pangritz
Biogen Idec, Inc. / Joanna Koft
Bristol Myers Squibb / Richard Perry
Business & Decision / Peter Van Reusel
Capish Nordic AB / Anna Berg
Celgene Corporation / Monica Mattson
Center for Biostatistics in AIDS Research / Heather Ribaudo
Chiltern / Terek Peterson
Clinical Ink / David Gemzik
CompleWare Corporation / Michael Wright
Computer Sciences Corporation / Mark Tumelty
Critical Path Institute / Jon Neville
d-Wise Technologies / Dave Handelsman
Eisai, Inc. / William Standen (Will)
Eli Lilly and Company / Scott Getzin
ER Squared, Inc. / Robert Musterer
F. Hoffmann-La Roche Ltd / Jonathan Chainey
FDA / Mary Ann Slack
Gilead Sciences / Gregory Campbell
GlaxoSmithKline / Warwick Benger
GRMS Life Sciences / Thomas Guinter
IBM / Nancy Friedland
INC Research / David Cesario
ICON Clinical Research / Debra Anderson
inVentiv Health Clinical, LLC / Paul Slagle
Johnson & Johnson / Patrick Genyn
Lung R&D Clinical / Maggie Lo
McDougall Scientific Ltd. / Hong Chen
Merck & Co., Inc. / Brooke Hinkson
Merck KGaA / Markus Stoll
National Cancer Institute / Erin Muhlbradt
Navitas / Georgina Wood
Novartis Pharmaceuticals Corporation / Aparna Kulkarni
Pfizer / Unnat Patel
PRA International / Kent Letourneau
Premier Research Group / Trish Rice
Quality Data Services, Inc. / Ellina Babouchkina
Sanofi-Aventis / Karen Fanouillere
Santen, Inc. / Jeanina Worden
SAS Institute, Inc. / Bill Gibson
SGS Life Sciences Services / Tineke Callant
Shire Pharmaceuticals, Inc. / Diane Piper
Takeda Pharmaceuticals International Co. / Elizabeth Langevin
Target Health / Yong Joong Kim
UCB, Inc. / Trisha Simpson
CDISC / Nicole Harmon
Bron Kisler
Sheila Leaman
Stephen Pyke
Ann White

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

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