CDISC and its Standards – overview


CDISC – The Clinical Data Interchange Consortium, non-profitable organization that defines the world-wide standards for representing clinical & non clinical data, required by the regulatory authorities as part of submissions.

SDTM – Study Data Tabulation Model, representing the collected clinical data in standardized structure and controlled terminology.

ADaM – Analysis Data Model, representing study analysis data in defined datasets structure.

CDASHClinicat Data Acquisition Standards Harmonisation, describes the basic recommended data collection fields

SEND – Defining the structure and format of standard nonclinical tabulation datasets