Standard
for Exchange of Nonclinical Data (SEND)
Implementation Guide for Animal Toxicology Studies
Version 2.1 Draft
The Standard for Exchange of Nonclinical Data
(SEND) Models have been prepared by the SEND
Consortium to guide the organization, structure,
and format for non-clinical data submitted to
the FDA. The focus of the SEND Consortium is
data collected from animal Toxicology studies.
Version 2.1 of the SEND model has been released
for implementation by the CDISC SEND Team. Please
also refer to the Study
Data Tabulation Model (SDTM) which represents
the underlying conceptual model behind the SEND
standard. Comments on SEND Version 2.1 Draft
will be accepted until Thursday, April 21, 2005.
Comments on any of these documents can be submitted
through CDISC's public Discussion
Forum at any time.
| SEND Review Version 2.2 (pdf) |
| SEND Team Minutes (zip) |
