Version 4.0 of the SEND Conformance Rules represent a cumulative package of current and previously published Conformance Rules for SENDIG versions thru 3.1.1 and for SENDIG-DART v1.1. SEND Conformance Rules v4.0 comprise the most up-to-date rules for evaluating the conformance of SENDIG-DART v1.1 datasets and are intended to evaluate the conformance of SENDIG v3.0, SENDIG v3.1, and SENDIG v3.1.1 datasets.
When used along with the SEND Implementation Guides, the SEND Conformance Rules v4.0 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.