Regulatory & Compliance Services
The mission of the Regulatory & Compliance Services is to reinforce the University of Miami’s commitment to a culture of excellence by providing a strong foundation for the implementation, maintenance and assessment of all essential research compliance activities.
The Regulatory & Compliance Services reside within and reports to the Office of the Vice Provost for Research. This office is responsible for duties related to:
- Audits: Conducts routine audits of good clinical practice and responds to requests for directed audits submitted by the Institutional Review Boards (IRB), the Data and Safety Monitoring Committee or the Vice Provost for Research;
- Conflict of Interest: Maintains a robust program for financial disclosure and conflict of interest management;
- Research Integrity: Investigates and resolves allegations of misconduct as directed by the Vice Provost for Research; and
- Institutional Committees: Provides support for compliance committees as mandated by federal regulations.
- University Offices: Liaises with other University of Miami offices including the Human Subject Research Office (HSRO), Radiation Control, and Environmental Health & Safety (EHS).
- The Export Control Compliance Office reports to the Office of Research Administration: This Office maintains an export control compliance program to assist investigators and faculty in the appropriate transfer of items, information, or equipment out of the U.S., or to a foreign national in the U.S.;
The Office of the Vice Provost for Research offers educational programs for investigators and research staff including workshops on specific research compliance topics such as good clinical practice, informed consent, documentation guidelines, adverse events, inspection readiness, and export control compliance. We provide custom programs for investigators and their staff when requested, and publish guidance documents on various research topics as necessary.
Clinical Research Operations & Regulatory Support (CRORS)
CRORS is part of the Research, Research Education & Innovative Medicine (RIM) Department, 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 on Harmonisation-GCP guidelines and local requirements, as well as for investigational new drug (IND) applications and investigational device exemptions (IDE).
For more information, visit the CRORS website.