SEND clinical trial

SEND clinical trial

SEND (Standard for Exchange of Non-Clinical Data)

The Standard for Exchange of Non-Clinical Data (SEND) is an implementation of the Study Data Tabulation Model SDTM for non-clinical studies. These types of studies are typically related to animal testing as part of pre-clinical (pre-Phase 1) clinical trials.

This standard was developed by the Clinical Data Interchange Standards Consortium’s (CDISC) SEND Team, which is committed to establishing a standard that can be used for the exchange and submission of non-clinical data collected from animal toxicology studies.

The work on this standard began in July 2002—subsequently, an FDA pilot project was initiated in July 2003 through a Cooperative Research and Development Agreement (CRADA). Feedback from this pilot and continuous efforts to more closely align this implementation with the SDTM for human clinical trials led to development of the current version, SEND v2.3, which covers single-dose, repeat-dose, and carcinogenicity studies.

References:

http://www.fda.gov/oc/datacouncil/send.html


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