Simplifying Global Compliance
The QMN Weekly Bulletin
Fake Data, Unqualified Researcher Land Investigator Warning Letter
June 22, 2012
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.
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