Page History

The FDA has mandated Sponsors whose studies start after Dec 17, 2016 , must submit their clinical study datasets in the Study Data Tabulation Model (SDTM) standard format.  For INDs, the requirement applies for studies that start after Dec. 17, 2017. SDTM provides a standard for organizing and formatting data to streamline the process in collection, management, analysis and reporting.  The The Clinical Data Interchange Standards Consortium provides SDTM standards that have been vetted by community members.

To support this mandate, the NCI is transition their current Network Rave Data Standards Initiative into the CDISC implementation