What type of studies does the FDA usually audit during inspections?

The FDA primarily focuses on auditing studies that are closed during inspections because these studies have completed their data collection and analysis and are therefore more likely to provide comprehensive insights into the conduct of the research, adherence to regulatory requirements, and accuracy of reported results. Closed studies allow inspectors to examine the overall integrity of the trial, assess the data handling process, and confirm that proper procedures were applied throughout the study lifecycle.

In closed studies, there is no ongoing patient interaction, which means inspections can be conducted without impacting patient safety or ongoing research activities. This closed status also allows for a thorough review of documents, data, and compliance with Good Clinical Practice (GCP) standards, which might be more challenging to assess in studies that are still enrolling subjects or in the early stages of execution.