US Food and Drug Administration Clinical Investigator Inspections

Objective: To review the US Food and Drug Administration (FDA) Bioresearch Monitoring clinical investigator inspection process from start to final classification to support clinical research nurses in practice. Data Sources: Published articles, websites, and author's expertise with FDA inspections. Conclusion: Clinical research nurses should conduct and manage every clinical trial as if it were to be inspected by the FDA. This recommendation is considered best practice for clinical research nurses to prevent last-minute preparations to organize and clean up research data and records retrospectively. Implications for Nursing Practice: This article will assist the oncology research nurse and interdisciplinary research members at the research site in the preparedness for an FDA inspection. (C) 2020 Elsevier Inc. All rights reserved.