Initiated by the Mayo Clinic Center for Clinical and Translational Science in its inaugural funding period, the Mayo Clinic Office of Research Regulatory Support (ORRS) is now a centralized resource for all Mayo Clinic researchers in all programs and locations.
The ORRS offers special expertise in Food and Drug Administration (FDA) regulations, including Investigational New Drug (IND) or Investigational Device Exemptions (IDE) applications, clinicaltrials.gov registration and results reporting, and serves as a liaison with other institutional resources such as Legal Contract Administration and the Institutional Review Board (IRB).
Current services include:
- Assistance with sponsor-investigator IND or IDE applications. Supports sponsor-investigators in understanding and meeting their sponsor obligations if they elect to be the holder of the IND or IDE. This includes personal consultation and helpful templates.
- FDA audit coordination and assistance. Assists with FDA audits, from the first phone call to the actual site visit.
- Education and training for FDA regulated studies. Provides online modules on a range of topics, from sponsor or investigator-initiated INDs to guidelines for organizing study documents for FDA-regulated research.
- Centralized resource for FDA communications and questions. Assures compliance with regulations and offers one-stop access to information regarding new legislation. This includes routinely monitoring the FDA website and related publications, publicizing relevant information to the research community, and providing oversight for the clinicaltrials.gov registration process.
- Centralized resource for registration and results reporting to clinicaltrials.gov. Supports research teams with registration and results reporting and provides guidance in determining whether a clinical research study must be registered, who is responsible for registration and whether results must be reported.