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.