Standard for Exchange of Nonclinical Data (SEND)

SEND Public Review


 

New Draft SENDIG v3.1 Draft B Now Available for Public Review – Comments due 10 September 2015

 

A second draft of CDISC SEND Implementation Guide v3.1 Draft B is now available for a 30-day public comment period.  SENDIG v3.1 Draft B includes new changes from the prior Draft A posting, and is focused on resolving ambiguity in two areas: schedules (e.g. VISITDY) and representation of timing. This review applies only to the changes in sections pertaining to these new sections on schedules and timing.  Please use the instructions in the README document contained in the review package to guide your review.

 

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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