Mission Possible: A Proposed SDTM Domain for the Medical Device and Diagnostic Industry
Carey Smoak · 2008
In May, 2006 a CDISC SDTM Device sub-team was formed. This sub-team has been working on a model to fill-in the gaps in SDTM for medical device and diagnostic companies. The focus has been on developing a domain that would contain information (metadata) about devices and not on results from devices. The sub-team has come up with a model that is currently being reviewed by industry experts. The proposed model is based on a custom Finding Observation Class domain. The advantage of this proposed model is that it is simple and extensible.