Major Milestone in Development of New CDISC Device Standard

The Clinical Data Interchange Standards Consortium (CDISC) announced a public review and comment period for the new CDISC Device Standards and encouragement for device companies to be involved in CDISC activities. This marks the first development by CDISC of standards for device trials. The draft document contains seven proposed new Study Data Tabulation Model (SDTM) domains that are designed to capture basic information about medical devices for the purpose of streamlining product reviews by the Food and Drug Administration (FDA). These domains have been modeled on and work in concert with existing SDTM constructs.

The goal of the CDISC Device Team, comprised of representatives from AdvaMed member device companies, CDISC experts, FDA-CDRH (Center for Devices and Radiological Health), and FDA-CBER (Center for Biologics Evaluation and Research), has been to identify the basic data collection fields, the submission variables, and associated metadata and mappings to support the majority of device studies and modalities, i.e. diagnostic devices, implantable devices and imaging devices. “These seven new proposed SDTM Device domains are a major milestone for the CDISC Devices Team,” quoted Carey Smoak of Roche, charter member and current Co-Leader of the CDISC Devices Team. “We encourage review from the clinical research community in the effort to ensure that this draft standard effectively meets the needs of all audiences.”

We anticipate that in the coming years there will be a series of continuing enhancements and additions to this initial device standard document. Developments of this kind are not possible without the dedicated efforts of numerous CDISC volunteers and members representing organizations across the healthcare and biopharmaceutical industries. Additional device companies interested in participating in the development of device standards are encouraged to consider collaborating with CDISC to lend their voices to the continual process of standards improvement. “Without the support of our members, volunteers and sponsoring companies, progress on this evolving and important device standard would not have been possible,” added Rhonda Facile, CDISC Senior Director of Standards and Development.