CDISC Standards Overview

Every sponsor once structured trial data differently, making regulatory review slow and pooling across studies painful. CDISC (Clinical Data Interchange Standards Consortium) created global standards so that: • regulators can review data with standard tools, • sponsors reuse processes and code across studies, • data can be pooled for meta-analyses and safety reviews. FDA (and Japan's PMDA) require CDISC standards for many submissions; FDA's Data Standards Catalog lists supported versions.