2016 FDA warning letters: Findings for clinical investigators

Each year the Food and Drug Administration (FDA) releases metrics on the Bioresearch Monitoring (BIMO) Program. The purpose of the BIMO program is to inspect FDA-regulated clinical trials to ensure the rights, safety and welfare of human research subjects have been protected and that the validity of research data is accurate to support a marketing application.

When serious violations are found during a BIMO inspection, a warning letter is issued. These BIMO inspection metrics provide the common findings that are found during these inspections by fiscal year (FY). According to the United States federal government, the FY begins on October 1st of the previous calendar year and ends on September 30th, the year in which it is numbered.

In FY 2016, there was a total of 1055 Bioresearch Monitoring Inspections including 775 inspections of Clinical Investigators (2016). At IMARC Research, Inc. these letters were reviewed, as they have been reviewed in previous years, to increase our understanding of FDA’s current focus, so that as monitors and auditors, we can provide better guidance to our sponsors and investigators. There were six study investigators who were issued FDA Warning Letters.

To review FY 2016’s top findings for clinical investigators in more detail, check out IMARC’s new whitepaper.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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