What is the primary focus of inspectors during a FDA inspection?

The primary focus of inspectors during an FDA inspection is to review regulatory records. This involves a comprehensive examination of documents and data related to the clinical trial, including informed consent forms, source documents, case report forms, and any records pertaining to compliance with Good Clinical Practice (GCP) guidelines and other regulatory requirements. The aim is to ensure that the study is being conducted in accordance with the protocol, ethical standards, and applicable regulations.

Reviewing regulatory records is crucial because it allows inspectors to verify that the data generated throughout the study is accurate and that the rights and welfare of the participants are protected. Thorough documentation is essential for maintaining the integrity of the clinical trial and for ensuring that it meets the necessary legal and ethical standards set by the FDA. This rigorous inspection process helps safeguard public health by ensuring that only reliable and safe products can move forward in the approval process.