Fake Data, Unqualified Researcher Land Investigator Warning Letter
A dishonest and insubordinate study coordinator has compromised a clinical trial, endangered subjects and led the site’s clinical investigator to discontinue conducting clinical research, according to an FDA warning letter. The May 25 letter was sent to Elizabeth Houser, who as the site’s clinical investigator ultimately bears the burden of assuring her staff’s work meets regulatory standards. An agency Bioresearch Monitoring, or BIMO, program inspection cited Houser for submitting false information to the study’s sponsor, the warning letter, posted online in early June, states. Clinical Trials Advisor
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The FDA's new enforcement plan makes one thing clear: Developing a successful CAPA program has never been more important. But creating an FDA-proof CAPA isn’t easy. If only you could pick the brain of someone who is coping successfully with CAPA — the best and the brightest, an industry leader who has devised programs, procedures and solutions that have put companies out in front with the FDA. Well, you can. Register today.Read More
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