MC CR Shared Services

Office of Research Education

The Office of Research Education provides core education and guidance to advance clinical research across the Mayo Clinic Research shield. ORE develops and deploys exceptional educational resources and opportunities that support and empower clinical research study teams to meet all Mayo Clinic care, compliance, and regulatory requirements effectively. ORE collaborates with subject matter experts to provide education, tools, and resources needed by the clinical research workforce

Office of Research Regulatory Support (ORRS)

ORRS serves as a high-quality centralized resource for all Mayo Clinic researchers in navigating the complexities of maintaining compliance with Mayo Clinic policies and FDA regulatory requirements for research drugs, biologics, devices or other test articles.

Office of Sponsored Projects Administration (OSPA)

OSPA staff provides training and education for individuals, study staff, and the Mayo Clinic research community on research related policy, procedures, systems and tools. OSPA staff is responsible to review all proposals and awards to ensure administrative and financial conformance.

Post Award Billing Compliance (PABC)

PABC provides support to study teams by ensuring compliant billing for patient care in research studies. The team supports research billing review, IDE setup in Epic, research patient care pricing, and research billing questions.

Biosafety

Research Biospecimen Management provides approval for the collection, research use and/or distribution of human biospecimens.

Code and Coverage Analysis(CCA)

CCA is part of the Office of Clinical Trials (OCT) and specifically provides support to study teams by providing comprehensive analysis to identify which patient care services should be charged to research and which can be billed to Medicare or a third-party payer, based on Medicare statutes and regulations.

Office of Clinical Trials (OCT)

OCT facilitates the timely activation of clinical trials, conducts all Code and Coverage Analyses, supports Pragmatic Clinical Trials, guides the creation of effective recruitment and advertising plans, facilitates hiring research coordinators via the Research Hub, and provides RPS and Coordinator resources as needed. The OCT leads various initiatives to enhance clinical trial activation and study conduct at the Mayo Clinic.

Industry Funding Team (IFT)

The IFT is part of the Office of Clinical Trials (OCT) and specifically supports research funded at Mayo Clinic by for-profit industry sponsors through budget development, proposal submission, and payment milestone negotiations. IFT negotiates research budgets with industry sponsors within research service agreements, clinical trial agreements, and subcontracts. IFT also provides training and education to the Mayo Clinic research community on budget development, payment milestone considerations, and industry related research policies.

Institutional Review Board (IRB)

The IRB ensures the protection of all human participant's rights, privacy, and welfare in research programs conducted by Mayo Clinic and associated faculty, professional staff, and students. Coexistent with participant protection is the goal of providing quality service to enhance the conduct of research.

Legal Contract Administration (LCA)

LCA is responsible for drafting and negotiating industry, federal, and foundation contracts on behalf of the Mayo Clinic and its investigators.