During an FDA inspection, what will the inspectors primarily review?

During an FDA inspection, inspectors primarily focus on regulatory records because these documents provide critical evidence of compliance with regulatory requirements governing clinical trials and research practices. Regulatory records encompass essential documents such as informed consent forms, eligibility assessments, clinical trial protocols, and reporting of adverse events, among others. These records are fundamental in ensuring that the trials are conducted according to Good Clinical Practice guidelines and FDA regulations.

The importance of regulatory records cannot be overstated, as they serve to verify that the trial was conducted ethically and that the rights and safety of participants were protected. They also provide evidence of data integrity and compliance with reporting requirements. Inspectors evaluate these records to ensure that the study adheres to the approved protocol and that any deviations are documented and justified.

Other options, while relevant to different aspects of a clinical trial or product development, do not fall under the primary focus of an FDA inspection. Statistical reports, publicity materials, and market analysis may provide insights or support functions but are not the core documents that demonstrate compliance with FDA regulations. Hence, during inspections, the emphasis is placed on regulatory records to ascertain adherence to clinical research standards.