The CRORS office was established in September 2011 under the direction of senior leadership to create an internal monitoring group for University of Miami sponsor-investigators who were conducting their own Investigator-Initiated IND/IDE 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:
- Risk-Based Clinical Trial Monitoring
- Guidance on clinical trial regulations and ICH GCP guidance
- Clinical Trial Regulatory Support as it pertains to submissions and maintenance of IND or IDE applications to the FDA
- Review of protocols, case report forms and other clinical trial specific forms
- Clinical Research Education