Accelerating Medical Device Trials with Data Harmonization – Audience Q&A
The webinar, hosted by the Medical Device Innovation Consortium (MDIC) in collaboration with CDISC and Veeva MedTech, focused on accelerating medical device and diagnostic innovation through clinical data standardization. Below are selected audience questions and responses from the panelists.
SDTMIG v4.0 will not subsume SDTMIG-MD; the SDTMIG-MD will continue as a standalone implementation guide. However, SDTM v3.0, SDTMIG v4.0, and SDTMIG-MD v2.0 are being developed concurrently to ensure cross-domain consistency. For example, root variable definitions are being reviewed to confirm they accurately reflect usage within device domains. The SDTMIG-MD v2.0 is anticipated to be released for Public Review in Q2-2026. Please refer to additional information relating to the development of SDTMIG-MD on https://www.cdisc.org/standards/timeline
Capturing UDIs in real-world data remains inconsistent due to lack of standardized documentation and integration across systems. NEST is actively addressing these challenges through stakeholder engagement, best practice frameworks, and advocacy for structured UDI fields. However, widespread adoption will require coordinated efforts in policy, technology, education, and collaboration. While progress is underway, achieving reliable UDI capture across RWD sources will take time and sustained commitment from all sectors involved.
The Data Standardization Working Group is not working with medical schools at this time. Our focus is to continue building industry support for clinical data standards.
Clinical data standards can certainly help simplify and standardize the structure of a CIP/Protocol. Standard data elements for collection, submission, and analysis will help inform what data is collected for a study. CDISC has well-defined rules around controlled terminology (CT) that the industry can start to adopt.
Refer to the FDA website page Study Data Standards Resources for data submission requirements.