Standard for Exchange of Nonclinical Data (SEND)

SEND Public Review

Developmental and Reproductive Toxicology Version 1.0 (Draft) Now Available for Public Review – Comments due 13 August 2015

 

The CDISC SEND Implementation Guide: Developmental and Reproductive Toxicology (SENDIG-DART) v1.0 draft supports study data typically found in embryo-fetal developmental (EFD) toxicity studies and is based on the SENDIG for single-dose general toxicology, repeat-dose general toxicology, and carcinogenicity studies.  While this release (v1.0) focuses on EFD, other study designs will be covered in future releases.

 

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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