Specific services offered by the IIS include, but are not limited to, the following:
- Provide information regarding current FDA regulations and guidance documents pertinent to the preparation and submission of investigator-sponsored IND and IDE applications and the conduct of clinical investigations under such FDA-accepted applications;
- Assist University researchers in determining if there is a requirement for the submission of an IND or IDE application for their planned clinical investigations;
- Assist University researchers in identifying appropriate expertise and facilities as necessary for the preparation (i.e., “manufacturing”) of drugs and devices being evaluated under investigator-sponsored IND and IDE applications;
- Assist University researchers in identifying appropriate facilities for the conduct of cGLP-compliant, non-clinical (i.e., animal or in vitro laboratory) pharmacology/toxicology (i.e., safety) studies to be submitted in support of investigator-sponsored IND and IDE application;
- Assist University researchers with FDA communications related to planned, submitted, or accepted IND and IDE applications;
- Ensure institutional awareness of the submission of University-based IND and IDE applications and respective FDA communications;
- Coordinate Education and Compliance Support for Human Subject Research (ECS-HSR) monitoring of clinical investigations being conducted under University-based IND and IDE applications.