Catherine Carr, M.S.

My responsibilities include serving as the regulatory expert for NIDDK extramural and intramural studies.  This includes providing early consultation in determining the need for an IND/IDE, protocol development, study drug issues, and other regulatory matters.  This also includes providing consultation on NIDDK technology transfer agreements that involve FDA regulated studies.  For NIDDK trials that require a regulatory application (IND/IDE) for the use of an investigational drug or device in a clinical trial, I serve as the authorized sponsor representative for the Institute and the official regulatory liaison with the FDA.  I work with the Intramural Investigators, Program Officials, and Data Coordinating Centers to initiate regulatory applications, maintain applications (e.g., annual reports, protocol amendments), and assist with safety reporting to the FDA.  I am also responsible for managing regulatory records, including electronic submissions and Part 11 compliance.