FDA EIR - Emory University Hospital/Emory Eye Clinic - February 05, 2014

An FDA inspection was conducted at Emory University Hospital/Emory Eye Clinic in Atlanta, GA, from January 14 to February 5, 2014. This targeted inspection reviewed an ongoing clinical trial operating under an Investigational Device Exemption (IDE), following the regulatory framework of CP 7348.810, concerning Sponsors, Contract Research Organizations, and Monitors. The inspection identified primary issues related to the study ’s sponsorship and associated responsibilities, particularly regarding financial disclosures and investigator agreements for clinical sites. Specifically, there was a lack of consistent documentation for these critical elements between 2009 and 2013, which are requirements for the supporting NIH/National Eye Institute grant. An initial concern about a missing annual report since 2011 was resolved when the firm provided evidence of its submission. Following extensive discussions and a meeting with the Department of Ophthalmology Grants and Contracts Office, the identified issues were adequately resolved during the inspection. Consequently, while an FDA Form 483 (Inspectional Observations) was prepared, it was not officially issued. Emory University ’s Office of Research Compliance further committed to addressing the institutional processes for documenting sponsor responsibilities, financial disclosures, and investigator agreements to prevent future recurrences. Management was cooperative throughout the inspection.