Standard for Exchange of Nonclinical Data

ANNOUNCING - SEND Implementation Guide V3.0!

The CDISC SEND Team is pleased to announce the release of the SEND Implementation Guide (IG) Version 3.0.

The SENDIG is 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 the US Food and Drug Administration (FDA).

Version 3.0 of the SENDIG in now the production version and is designed to support single-dose general toxicology, repeat-dose general toxicology, and carcinogenicity studies.  The SENDIG is based upon and should be used in close concert with Version 1.2 of the CDISC Study Tabulation Model (SDTM).

SENDIGv3.zip contains the IG in .pdf format.

Download SENDIGv3.zip here!

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The following links are useful to SEND users.

Documents referenced in the SEND Implementation Guide:

Case Report Tabulation Data Definition Specification

CDISC

CDISC Glossary

Define.xml specification

ISO 8601 Standards

NCI Thesaurus

SEND Controlled Terminology

SDTM (Study Data Tabulation Model)

SDTMIG Version 3.1.2

Study Data Specifications [FDA Electronic Common Technical Document (eCTD) - Study Data Specifications]

UNII

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Questions? Comments?

The CDISC SEND Team is always interested in your comments or questions.  Any feedback regarding SEND can be submitted to the CDISC SEND Team via email address: review@cdisc.org or by contacting any member of the CDISC organization.