February CDISC INTRAchange
Thurday, April 2, 2009
Carey Smoak
Device Team Leader
Li Zheng
Submission Data Standards Team
Member
CDISC©2009
INTRAchange - Introduction
• Different from Annual Interchange
• For CDISC technical team members only, two
times every year
• FDA present at the meeting
• Cross team information exchange and sharing,
issue discussion to ensure standards are
harmonized
• Opportunity for team members and sub-team to
meet face-to-face
CDISC©2009
INTRAchange: SDTM
• 115 participants from the CDISC technical teams
gather together to discuss, develop and share
information about the CDISC standards.
• 20 FDA personnel were in attendance.
– This high level of interest reflects a new era of open
communication between the FDA and CDISC and
highlights the strength of the FDA’s commitment to
the CDISC standards.
CDISC©2009
INTRAchange: SDTM
• In recent months, CDISC has faced a lack of
understanding about the future of SDTM.
• CDISC team members expressed their concerns
about the present uncertainties.
• Dave Iberson-Hurst, CDISC VP, Technical
Strategy and Diane Wold, Trial Design Model
(TDM) Team Leader presented diagrams of
what this future may encompass, which
attendees found very useful.
CDISC©2009
INTRAchange: SDTM
• “Some people are thinking SDTM is being
replaced or going away; nothing is further from
the truth,” said Armando Oliva, FDA Deputy
Director for Bioinformatics, Office of the
Commissioner, Critical Path Programs.
• SDTM is currently valuable to the FDA and Dr
Oliva stated that there is a need to increase the
number of current submissions in SDTM format.
CDISC©2009
INTRAchange: SDTM
• SDTM is expected to become even more
valuable in the future when HL7 V3 messages
are used from 2013 onwards.
• The SDS Team started discussions about SDTM
Version 3.1.3 and discussed a collaborative
approach that will be needed in the future,
whereby SDTM domains, CDASH collection and
Controlled Terminology are developed
simultaneously.
CDISC©2009
INTRAchange: SEND
• The SEND team and SDS team met to discuss
the differences between clinical and nonclinical
trial designs and how best to harmonize the
models for implementation across all trials.
• These discussions are critical to the preparation
of an upcoming first release of the Trial Design
model for nonclinical studies and for submission
of nonclinical study data in the FDA SEND pilot.
CDISC©2009
INTRAchange: SEND
• In addition, the SEND team held their first FDA /
SEND session.
• The session was attended by industry members
(pharma and CRO), the CDISC leadership, team
members from related CDISC teams, as well as
7 FDA representatives from various FDA
divisions (including CDER, CVM, and CBER).
• Topics included: revisions to the SEND model,
procedures for the FDA SEND pilot, and
discussion of cross-divisional implementation of
SEND at the FDA.
CDISC©2009
INTRAchange: SEND
• The feedback from attendees indicates that this
was a very valuable discussion and there is
much interest in continuing these types of
interactions at future INTRAChange meetings.
CDISC©2009
INTRAchange: ADaM
• The ADaM team had their first dedicated "ADaM
and the FDA" session.
• This included a discussion about ADaM and HL7
v3 messages.
• There was also a meeting with the ADaM team,
the SDS team and the FDA about derived data.
CDISC©2009
INTRAchange: ADaM
• There is increased interest from the FDA in
ADaM and in recent weeks the FDA has been
undergoing ADaM training.
• The ADaM team meeting included interesting
discussions about the public comments on draft
ADaM 2.1 and ADaMIG 1.0.
CDISC©2009
INTRAchange: CDASH
• The CDASH team members were working
alongside many of the technical teams during
the event.
• They also considered some of the key elements
that had been raised by the public review of
CDASH v. 1.0.
• Some language regarding screening failures
needs to be added to the standard. They agreed
to address this issue in the forthcoming CDASH
Implementation Guide and they are hoping to
have FDA input on this issue.
CDISC©2009
INTRAchange: CDASH
• There will be ongoing revisions to CDASH v1.0
and the CDISC website will have all the future
information.
• The CDASH & ODM teams met together to
discuss joint deliverables including: Library of
items; Implementation of Forms (PDF and
HTML); Tables and metadata; CRF
Representations
• The CDASH & Device teams also met together
to discuss joint development of domains.
CDISC©2009