483
Julio WainsteinFDA 483 - Julio Wainstein - February 13, 2019
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Record Details
An FDA inspection of Julio Wainstein, a clinical investigator in Tel Aviv, Israel, revealed a significant failure to maintain adequate and accurate case histories. Specifically, numerous adverse events and concomitant medications for randomized subjects were not documented in source documents or final case report forms. This indicates a serious deficiency in data integrity and record-keeping practices.
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ID · 8c0a42a2-a864-4844-9ea3-0549a128a29f