SEND Conformance Rules v4.0

Comments Due By

CDISC invites you to submit comments on version 4.0 of the SEND Conformance Rules during Public Review. The SEND Conformance Rules v4.0 include 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.

When released, the SEND Conformance Rules v4.0 will represent a cumulative package of current and previously published Conformance Rules for SENDIG versions thru 3.1.1 and for SENDIG-DART v1.1.

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Public review is a key quality step in our Standards Development Process. CDISC relies on your input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in improving research processes and quality for the benefit of all.

Thank you for contributing your time and expertise.