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Standardization for Exchange of Nonclinical Data (SEND)

Home / Publications / INHAND/SEND / SEND FAQs

SEND has been finalized. Studies supporting NDA submissions that start (protocol signature date) after December 18, 2016, and studies supporting IND submissions that start after December 18, 2017, must be submitted with electronic data as specified in the electronic data standards catalog. Federal Register Notice.


Frequently Asked Questions

1. SEND

    SEND is the Standardization for Exchange of Nonclinical Data.

2. What is SEND?
SEND is an implementation of the Study Data Tabulation Model (SDTM) for nonclinical toxicology studies and is intended to provide a structured representation of information included in study report appendices.
3. What terminology will SEND use?
SEND terminology will predominately use INHAND nomenclature.
4. What is SENDIG?
SEND Implementation Guide. The implementation guide is a set of instructions and examples of how to structure data into the SEND format.
5. What is SDTMIG?
SDTM Implementation Guide for Human Clinical Trials.
6. When will SEND be implemented?
SEND v3.0 is in production now and available for use. SEND v 3.0 is also the US FDA’s preferred and supported format for general toxicology and carcinogenicity study data. SEND and SDTM are also expected to become required under Prescription Drug User Fee Act (PDUFA) V. The date of requirement will be based upon the release of a final guidance. US FDA has suggested that this will be in the first half of 2013.
7. What is CDISC?
There are many variations of but the majority have suffered alteration in some form, by injected humour, or randomised words which looks.
8. What is the SEND Implementation Wiki?
The SEND Implementation Wiki is a wiki site aimed at those implementing SEND as a companion to the SENDIG. This site will be an evolving site that includes information on the fundamentals of SEND, getting SEND-ready, known issues and FAQs.
9. What if I have other questions?
Consult the SEND FAQs on the SEND Implementation Wiki. This is a SEND-sponsored FAQ page with an extensive knowledge base.

SEND Webinars and Presentations

STP-Sponsored SEND Webinars: Other SEND Presentations:

SEND Links

Industry Related SEND Links US FDA-Related SEND Links
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