483
Dr. Heino Enn Arpo, Clinical InvestigatorFDA 483 - Dr. Heino Enn Arpo, Clinical Investigator - November 24, 2006
Record Details
The FDA inspected Dr. Heino Enn Arpo, a Clinical Investigator in Tallinn, Estonia, for bioresearch monitoring. The inspection revealed a failure to prepare and maintain adequate and accurate case histories. Specifically, a subject's severe diarrhea was not documented on the Case Report Form as required by the study protocol for adverse events.
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ID · 7d5c6240-e0ec-41ee-ab4b-4fea2f4c3526