CDISC SEND 3.0

The CDISC SEND standard defines a standard structure for data tabulations that are designed to support single-dose general toxicology studies, repeat-dose general toxicology studies, and carcinogenicity non-clinical studies. CDISC SEND is based on CDISC SDTM. These data tabulations are submitted as part of a product application to a regulatory authority such as the FDA.

The data sets and columns required for a product application are not prescribed by the standard. Instead, requirements are based on the trial protocol and discussions with the regulatory authority in charge of reviewing the application. Therefore, any SAS Clinical Standards Toolkit standard, including the CDISC SEND standard, is only a representative sample or template.

CDISC Standard for Exchange of Nonclinical Data (SEND), Final Version 3.0, May 19, 2011

The SAS Clinical Standards Toolkit representation of the CDISC SEND 3.0 standard consists of 28 domains (in the reference_tables metadata data set) and 563 columns (in the reference_columns metadata data set).