R Foundation adopts Certification/Validation document (fwd)

[Paulo Justiniano Ribeiro Jr <paulojus@c3sl.ufpr.br>]

Caros
segue uma msg relevante especialmetne para os envolvidos com ensaios
clinicos

Paulo Justiniano Ribeiro Jr
LEG (Laboratorio de Estatistica e Geoinformacao)
Universidade Federal do Parana
Caixa Postal 19.081
CEP 81.531-990
Curitiba, PR  -  Brasil
Tel: (+55) 41 3361 3573
Fax: (+55) 41 3361 3141
e-mail: paulojus AT  ufpr  br
http://www.leg.ufpr.br/~paulojus



---------- Forwarded message ----------
Date: Thu, 25 Sep 2008 22:57:40 +0200
From: Martin Maechler <maechler@stat.math.ethz.ch>
To: R-announce@r-project.org
Subject: R Foundation adopts Certification/Validation document


The Board of the R Foundation would like to announce the unanimous
adoption of the document entitled:

"R: Regulatory Compliance and Validation Issues. A Guidance Document for
the Use of R in Regulated Clinical Trial Environments"

The updated version of the document, dated August 17, 2008, is available
from the main R web page (http://www.r-project.org/) via the
Certification link, listed under Documentation.

The document provides extensive background and detailed guidance for the
use of R within the regulated framework of human clinical trials,
covering GxP and 21 CFR Part 11 issues. This document should serve R
users as a key reference for their internal regulatory activities
relating to the use of statistical software for clinical trials.

We would like to thank all of those whose hard work has resulted in this
finished document!

- - - - -

For The R Foundation for Statistical Computing,
Martin Maechler
ETH Zurich

Note: As an exception, we are announcing this through R-announce.

_______________________________________________
R-announce@stat.math.ethz.ch mailing list
https://stat.ethz.ch/mailman/listinfo/r-announce