Version 5.0 of the SEND Conformance Rules represents a cumulative catalog of rules associated with all published SENDIGs except SENDIG-Animal Rule v1.0. New content in SEND Conformance Rules v5.0 includes rules for SENDIG-DART v1.2 and SENDIG-GeneTox v1.0.
When used along with the SEND Implementation Guides, the SEND Conformance Rules v5.0 are intended to guide the organization, structure, and format of standard non-clinical tabulation datasets for interchange between organizations, such as sponsors and CROs and for submission to regulatory authorities.
Public Review Comments
CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.