Standard for Exchange of Nonclinical Data (SEND)

New Draft SENDIG Version 3.1 (Standard for Exchange of Nonclinical Data Implementation Guide) Now Available for Public Review– Comments due 04 December 2014

 

The draft CDISC SEND Implementation Guide (IG) Version 3.1 is intended to guide the organization, structure, and format of nonclinical tabulation datasets for interchange between organizations such as sponsors and CROs and for submission to the US Food and Drug Administration (FDA). This version of the SENDIG expands upon the original 3.0 release, which supports data typically found in single-dose general toxicology, repeat-dose general toxicology, and carcinogenicity studies, by the addition of domains to support respiratory and cardiovascular testing done during safety pharmacology studies, as well as other changes to improve the base guide. The changes are described in section 1.3 of the SENDIG. The SENDIG is based upon Version 1.4 of the CDISC Study Data Tabulation Model (SDTM) and should be used in close concert with CDISC SDTM Implementation Guide (SDTMIG) v3.2, and Controlled Terminology Package 19.

 

Please access the document package and provide comments through the CDISC Public Comment Tracker tool 

 

You will need to login or register for a CDISC portal account to use the tool.  Help is also available on the Public Comment Tracker page.

 

Instructions on using the Public Comment Tool.

 

 

SEND Implementation Guide v3

 

The CDISC SEND Implementation Guide (IG) Version 3.0 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 the current 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).

 

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 through the CDISC Discussion form.

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