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Catherine Carr, M.S.

Regulatory support for NIDDK clinical trials with investigational drug or device use

Responsibilities & Activities

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.

My responsibilities also include serving as the regulatory expert on existing and new regulatory requirements (FDA and GCP) as well as establishing new policies to ensure NIDDK is in compliance with these requirements.  This responsibility includes promoting best practices and consistency across NIDDK regarding regulatory decisions, processes, and sponsor obligations. 

Committees & Working Groups

  • Clinical Studies Working Group, Member