CRORS is part of the Office of the Executive Dean for Research (EDR) within the Miller School of Medicine at the University of Miami. We provide regulatory support for the conduct of research in respect to FDA, Office for Human Research Protections and state regulations, International Conference of Harmonization-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 three distinct areas:
- Risk-Based Monitoring
- Regulatory Support as it pertains to submissions and maintenance of IND or IDE applications to the FDA
- Clinical Research Education