IITS-U was established under the direction of senior leadership to support University of Miami sponsor-investigators who were conducting their own Investigator-Initiated IND/IDE studies and principal investigators conducting other interventional drug or device studies. We provide regulatory support for the conduct of research with respect to FDA, Office for Human Research Protections and state regulations, International Conference of Harmonization (ICH)- Good Clinical Practice (GCP) guidelines and local requirements, as well as for investigational new drug (IND) applications and investigational device exemptions (IDE).
Our office provides services to the research community in the following areas:
- Clinical trial regulatory support as it pertains to:
- Review of protocols, case report forms and other clinical trial specific forms
- Submissions and maintenance of IND or IDE applications to the FDA
- Review of protocols, case report forms and other clinical trial specific forms
- Risk-based clinical trial Monitoring
- Project management for multi-site IITs
- Data management for multi-site IITs
- Safety management for multi-site IITs
- Guidance on clinical trial regulations and ICH GCP guidance
- Clinical research education