Between 1997 and 2008 there were 3,818 “valid” US FDA site inspections; 3,304 (86.5%) of them Data Audit inspections and 514 (13.5%) for Cause inspections. The most common deficiencies identified are “Failure to follow investigational plan” (34.2%), “Inadequate and inaccurate records” (25.1%), “Inadequate drug accountability” (9.6%), “Inadequate informed consent form” (8.9%) and “Failure to report adverse drug reactions” (8.5%).A statistical significantly higher number of deficiencies are reported for Western Europe than other regions, Rest-of-the-world has in general somewhat better inspection results than North America, and North America has somewhat better results than Europe. East Europe, with 150 completed US FDA inspections, has the best overall results: this data failed to justify globalizations concerns.

Globalization of Clinical Research

DONDI DALL'OROLOGIO, GIOVANNI
2009

Abstract

Between 1997 and 2008 there were 3,818 “valid” US FDA site inspections; 3,304 (86.5%) of them Data Audit inspections and 514 (13.5%) for Cause inspections. The most common deficiencies identified are “Failure to follow investigational plan” (34.2%), “Inadequate and inaccurate records” (25.1%), “Inadequate drug accountability” (9.6%), “Inadequate informed consent form” (8.9%) and “Failure to report adverse drug reactions” (8.5%).A statistical significantly higher number of deficiencies are reported for Western Europe than other regions, Rest-of-the-world has in general somewhat better inspection results than North America, and North America has somewhat better results than Europe. East Europe, with 150 completed US FDA inspections, has the best overall results: this data failed to justify globalizations concerns.
G.Dondi dall'Orologio
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11585/101289
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