Investigational New Drug (IND) and Investigational Device Exemption (IDE) application support is available to NC TraCS Institute Investigators. Investigators in need of IND or IDE support may contact the Regulatory Core IND/IDE Specialist, Amy Franklin, who can provide full-service regulatory support for the application, decreasing the burden on investigators as they attempt to navigate FDA regulations.
The primary objectives of the Regulatory Core IND/IDE Support Program are to:
1. Provide a centralized resource of information and support related to addressing regulatory requirements, obligations, and responsibilities that govern the conduct of clinical research studies under investigator-sponsored INDs and IDEs.
2. Assist UNC researchers in their compliance with the regulatory requirements, obligations and responsibilities associated with the conduct of clinical research studies under investigator-sponsored INDs and IDEs
3. Ensure appropriate institutional oversight of commitments made under investigator-sponsored INDs and IDE.
Investigators who have questions or need guidance regarding the need for an IND or IDE for their research proposals may contact Amy Franklin at 919-843-9514 for a one-on-one consultation appointment or may submit a request via an NC TraCS consultation form.