Usefulness of CJUG SEND check tool to ensure the quality of SEND dataset

Abstract

Standard for Exchange of Nonclinical Data (SEND) was published as the data standard format for nonclinical studies by CDISC.

Applicants to FDA must submit the electronic study data of nonclinical safety studies (SEND dataset), not only in compliance with CDISC standard (SEND Implementation Guide, Controlled Terminology, etc), but also with the FDA-issued documents (Study Data Technical Conformance Guide, Business Rules, etc.).

CJUG SEND team created a check tool to check SEND dataset with SAS program based on the check items covered the above documents and rules. We will show the usefulness of check tool to ensure the quality of SEND dataset.