EDR: Executive Dean for Research

About Us

Our office was established in September 2011 under the direction of senior leadership, to establish an internal monitoring group for the University of Miami’s investigators who were conducting their own investigator-initiated IND/IDE studies. The CRORS office was formally part of the Research Compliance office known as Regulatory Support & Quality Assurance (RSQA). Since April 2014, our group was separated and renamed Clinical Research Operations & Regulatory Support (CRORS).

CRORS is in the process of developing three distinct areas:

  • Monitoring
  • Regulatory Support
  • Research Education

We provide the following services to the research community:

  • Risk-based Approach to Monitoring
  • Research Education
  • Training Programs (for investigators and their research teams)

Additionally, we provide regulatory support for the conduct of research in respect to FDA, Office for Human Research Protections and state regulations, International Conference on Harmonisation-GCP guidelines and local requirements, as well as for investigational new drug (IND) applications and investigational device exemptions (IDE).

CRORS is part of the Research and Research Education (RIM) Department, within the Miller School of Medicine at the University of Miami.

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