FDA Inspection of Investigator Sites in Italy

Abstract

The United States Food and Drug Administration (FDA) conducts investigator site inspections both in the United States and foreign countries. This paper reports on the experience of an FDA inspection performed at two Italian centers producing data submitted to the FDA in support of a new drug application (NDA) for market approval. The inspection procedures outside the United States are the same as those for domestic inspections and are naturally subject to any local legislative requirements.

The inspection focused on the flow of information between sponsor and investigator, procedures for Ethic Committee authorization and patients' consent, and transcription of patients' data onto case record forms. All documents in the investigator file were examined and a 100% data audit was conducted for all subjects enrolled into the study.