A CDISC SDTM model for the medical device and diagnostic industry

Abstract

Abstract In May 2006, a CDISC SDTM Device sub-team was formed. This sub-team is made of industry experts, CDISC representatives and FDA representatives. This sub-team has been working on a model to fill-in the gaps in SDTM for medical device and diagnostic companies. The initial 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.