FDA Clinical Investigator Site Inspections: The Sponsor's Role

Once a New Drug Application (NDA) is submitted to the Food and Drug Administration (FDA) for review and potential approval, it is likely that at least some of the clinical trial investigators will be inspected by the FDA. Study issues of noncompliance and/or data integrity can result in costly approval delays. This paper will describe the role of the sponsor in dealing with an FDA clinical trial site inspection including selection of clinical trial sites, timing of sponsor inspections, site coaching, and the sponsor's role during and after the FDA inspection. This preinspection program has been viewed as beneficial by company management and Eli Lilly and Company trial investigators who have been investigated. It is believed that the FDA benefits as well, by assuring that site documents and staff are in readiness for an efficient inspection.