CDISC©2009 February CDISC INTRAchange Carey Smoak Device Team Leader Li Zheng Submission Data Standards Team Member Thurday, April 2, 2009

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 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 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.