Route to SDTM Implementation in In-Vitro Diagnostic Industry: Simple or Twisted
Carey Smoak, Girish Rajeev · 2014
SDTM implementation for In-Vitro Diagnostic (IVD) data found a guiding light when CDISC came up with seven new domains specific to the medical device industry. Although these domains are not tailor-designed for diagnostic data, they serve as a good starting point for us to define SDTM+, which is an extension of the SDTM standards to accommodate the large variety of IVD data. The similarity across studies following SDTM domain structures presents opportunities for code standardization and reusability. What this paper hopes to achieve is to take the reader on our journey and explain briefly the company-specific standards created, the new domains and how our data was adjusted across SDTM+ domains. The main focus will be on mapping of IVD data with company specific use-case examples.