SEND Conformance Rules v3.0


Published Date:

Version 3.0 of the SEND Conformance Rules are intended to provide rules for evaluating the conformance of SENDIG v3.0, v3.1 and v3.1.1 datasets. The SENDIGs v3.0, v3.1, and v3.1.1 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.

SEND Conformance Rules Guide

The corresponding 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 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.