FDA updates Study Data Specification

The U.S. Food and Drug Administration (FDA) has released an updated version 1.6 of the "Study Data Specifications" used for submitting animal and human study datasets in electronic format.

The new version 1.6, version date 2011-06-22, includes now specifications for general toxicology and carcinogenicity data tabulation datasets. The corresponding "Standard for Exchange of Nonclinical Data Implementation Guide: Nonclinical Studies" has just been released by CDISC as final version 3.0. (SEND IG 3.0). The SEND IG 3.0 is now referenced in the Study Data Specification 1.6 as Implementation Guide for which corresponding SDTM datasets are accepted by CDER starting with June 22, 2011. 

The SEND IG 3.0 can be downloaded from the CDISC website, the Study Data Specifications 1.6 are available for download from the FDA website (see links at the bottom of this article).

[Sources: FDA website; CDISC website]

<- Zurück zu: News Archiv