Published Date:
Version 1.0 of the Conformance Rules for SENDIG v3.0 are intended to provide rules for evaluating the conformance of SEND v3.0 datasets. The SENDIG v3.0 is intended to guide the organization, structure, and format of standard nonclinical 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 during the standards development process