The primary objectives of the O3IS are to:
- Provide a centralized resource of information, expertise, and support related to addressing the complex regulatory requirements, obligations, and responsibilities that govern the submission of investigator-sponsored IND and IDE applications and the conduct of clinical investigations under such applications;
- Assist University researchers in complying with the regulatory requirements and responsibilities associated with the conduct of clinical investigations under FDA-accepted IND and IDE applications; and
- Ensure appropriate institutional oversight of commitments made under university-based IND and IDE applications.
Where to Begin
Am I required to submit an IND or IDE application?