FDA Audits and Protocol Complexity

August 1, 2015
Harold E. Glass, PhD

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-08-01-2015, Volume 24, Issue 8

The number of site audits performed has grown significantly.

An increasing amount of public data on clinical trial research has become available, including ClinicalTrials.gov and Open Payments. In addition, Europe has developed equivalent databases, or is in the process of developing them. The FDA has made its global site audit results available for some time to the public. The number of audits increased substantially, growing from 1,185 in 2008 to 10,264 in 2013, the last full year available. The summary results do indicate that up to 2010, the FDA increased the number of audits outside the U.S. However, since 2011, the percentage of sites audited outside the U.S. has remained stable at 26% to 28%.

The FDA reports results in three categories: no action indicated (NAI), official action indicated (OAI), and voluntary action indicated (VAI). Since 2008, there has been virtually no change in the audit results. 

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