SEND Conformance Rules v4.0


Published Date:

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.


Files

Please Sign in or Sign up to access the file(s) for this standard



Errata

An erratum (plural: errata) is a correction to a mistake made in a published standard, which was identified after it was published on the CDISC website, and which would have been corrected in the current version had it been identified prior to publication. Updates, revisions, substantive corrections, and other changes of enough significance to require a cycle through the Standards Development Process are not errata, and thus are not included on the pages below.