Version 2.0 of the Conformance Rules for the SENDIG v3.0 and v3.1 are intended to provide rules for evaluating the conformance of SENDIG v3.0 and SENDIG v3.1 datasets. The SENDIG v3.0 and SENDIG v3.1 are 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.
The SENDIG Conformance Rules Development and Documentation Guide explains the methodology used to create SEND conformance rules and the logic applied to determine which implementation guidance should be translated into rules.
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