CA "The Clinical Data Interchange Standards Consortium has achieved two significant milestones towards its goal of standard data models to streamline drug development and regulatory review processes. CDISC participants have completed metadata models for the 12 safety domains listed in the FDA Guidance regarding Electronic Submissions and have produced a revised XML-based data model to support data acquisition and archive."
Conclusions
RQ "The goal of the CDISC XML Document Type Definition (DTD) Version 1.0 is to make available a first release of the definition of this CDISC model, in order to support sponsors, vendors and CROs in the design of systems and processes around a standard interchange format."
SOW
DC "This team, under the leadership of Wayne Kubick of Lincoln Technologies, and Dave Christiansen of Genentech, presented their metadata models to a group of representatives at the FDA on Oct. 10, and discussed future cooperative efforts with Agency reviewers."... "CDISC is a non-profit organization with a mission to lead the development of standard, vendor-neutral, platform-independent data models that improve process efficiency while supporting the scientific nature of clinical research in the biopharmaceutical and healthcare industries"
