IND and IDE Support Services

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;
     
  • Provide education to University researchers regarding the regulatory requirements and responsibilities associated with the conduct of clinical investigations under FDA-accepted IND and IDE 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;
     
  • Provide University researchers with guidance regarding the content of an IND or IDE application.
     
  • 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;
     
  • 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;
     
  • Ensure institutional awareness of planned clinical investigations requiring the submission of University-based IND and IDE applications and/or of planned services (e.g., cGMP or cGLP facilities) to support the submission of such 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 the University-based preparation (i.e., “manufacturing”) of drugs and devices being evaluated under University-based IND and IDE applications; and
     
  • Coordinate Education and Compliance Support for Human Subject Research (ECS-HSR) monitoring of clinical investigations being conducted under University-based IND and IDE applications.