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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 providing regulatory support for all NIDDK trials that require a regulatory application (IND/IDE/CTA) for the use of an investigational drug or device in a clinical trial. I cover all research program areas at the NIDDK, including certain intramural studies. I provide regulatory consultation to aid in the determination of the need for an IND/IDE, protocol development, study drug issues, and other regulatory matters. I work with the program officials and data coordinating centers to initiate regulatory applications, maintain applications (e.g., annual reports, protocol amendments), and assist with safety reporting for clinical trials under IND/IDE/CTA. I am also responsible for managing regulatory records.

My responsibilities also include ensuring that the Institute is in compliance with any existing or new regulatory requirements and establishing new policy to ensure compliance as well as consistency with regulatory decisions and processes across the Institute.

Committees & Working Groups

  • Clinical Studies Working Group, Member
  • Regulatory Gap Working Group, Chair