FDA 483 - Diana T. Widicus, M.D. - April 03, 2026
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An FDA inspection of Diana T. Widicus, M.D., Clinical Investigator, in Springfield, IL, revealed significant issues with the accuracy and maintenance of clinical trial data. Observations included widespread discrepancies in serious adverse event (SAE) and adverse event (AE) data transcribed into electronic case report forms, as well as failures to report SAE end dates to the sponsor. Additionally, AE records were not accurately maintained, and a primary efficacy study endpoint was missing from source records, indicating a systemic problem with data integrity and record-keeping.
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