Newspaper article from our research archive:
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7-item 483 delivered to clinical investigator for protocol violations.(Clinical investigators)
- Article from:
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BioResearch Compliance Report
- Article date:
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December 1, 2007
- Author:
- Hendrick, Kim
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Copyright informationCOPYRIGHT 2007 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Kim Hendrick, M.D., Flushing, MI, was hit with a seven-item 483 because the clinical investigator failed to adhere to protocol in the area of independent radiological assessments of sinus X-rays. Investigator Laureen Kononen from the Detroit, MI, District Office conducted the inspection.
"The radiological group listed in the sinus x-ray assessments did not perform radiological interpretations of enrolled subjects as submitted to the sponsor by Dr. Hendrick's office," according to FDA documents. Assessments were noted for several screen failure subjects at that facility.
"Source documentation of x-ray interpretations by the radiological group listed on the assessments ...
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