Clinical Study
Using SDTM, ADaM, & SEND for Regulatory Submission
It’s a safe bet that most people’s first introduction to CDISC is through the Study Data Tabulation Model (SDTM). This is a content standard that ensures clinical data is submitted in a consistent manner, helping to reduce review time and facilitating cross study analysis. Another content standard, the Analysis Data Model (ADaM), aims to perform a similar function for analysis datasets. Likewise the Standard for Exchange of Nonclinical Data (SEND) defines standardized domains for non-clinical data.
