BUENAS PRÁCTICAS CLÍNICAS: PROTECCIÓN DEL INDIVIDUO Y SUS DERECHOS

Good Clinical Practice/ Human Subject Protection e-mail update service provided by the U.S. Food & Drug Administration (FDA).

The following documents were recently published by the FDA:

1) final guidance on the reporting of adverse events to IRBs. This guidance, entitled "Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs- Improving Human Subject Protection", is intended to provide assistance to the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to the IRB.

2) final rule on IRB registration requirements. This rule will be added to the Code of Federal Regulations as citation "21 CFR 56.106".

You will find both of these items posted to the GCPP web page (www.fda.gov/oc/gcp).
Patricia M. Beers Block

NOTA DEL BLOG: para quiénes deseen recibir la información descripta previamente en los puntos 1 y 2, en documentos PDF oficiales de la FDA, rogamos solicitarlos por mail a: cerasale314@gmail.com acreditando condición profesional del equipo de salud. Muchas gracias. OTROS DOCUMENTOS DE ESTA SERIE se incluyen en el BLOG: http://elbiruniblogspotcom.blogspot.com / Enero 2009.