483
McDougle, Christopher J., MDFDA 483 - McDougle, Christopher J., MD - March 12, 2004
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Record Details
Christopher J. McDougle, M.D., a clinical investigator in Indianapolis, IN, was inspected by the FDA from March 9-12, 2004. The inspection revealed a significant failure to maintain accurate case histories due to numerous data entry errors in study databases. These errors affected adverse event documentation and other subject records, indicating issues with data integrity.
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ID · ca491077-13c4-442e-bbbb-65220cb5c121