Major Milestone in Development of New CDISC Device Standard - Applied Clinical Trials


See our 2013 Buyers Guide Digital Edition.
Major Milestone in Development of New CDISC Device Standard

Source: Company News Release

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.

In recognition of the development of the draft Device Standard, all new device companies that join CDISC before the end of April will receive a 10% discount off the cost of their membership. F or information on CDISC membership, please visit the CDISC website: http// and click on “Membership,” or contact Sheila Leaman, CDISC Global Relations Manager:


blog comments powered by Disqus



8th Annual Forum on Transparency and Aggregate Spend 2014
Washington, DC
August 18-20, 2014

eSource Data in Clinical Investigations
Philadelphia, PA
August 20-21, 2014

Pharmacovigilance 2014
Philadelphia, PA
September 10-11, 2014

Collaborative Research Summit
Philadelphia, PA
October 15-16, 2014

See All Conferences >>

As it creates a plan to implement the US biosimilar pathway, should FDA:
Borrow heavily from EMA's pathway program?
Borrow lightly from EMA's pathway program?
Create entirely its own pathway program?
Borrow heavily from EMA's pathway program?
Borrow lightly from EMA's pathway program?
Create entirely its own pathway program?
View Results
Untitled Document
Source: Company News Release,
Click here