Research Compliance Cores
- Research Compliance, Education & Outreach
The Office of Research Compliance, Education & Outreach (ORC) is focused on a variety of areas including identifying best practices for the conduct of research; ensuring compliance with requirements and ethical standards; providing education and training for the research community, including Clinical Research Orientation and UH Investigator Training; and promoting and supporting research activities across the UH system.
- Institutional Review Board (IRB)
The UH Institutional Review Board (IRB) Administration Office is responsible for ensuring that all research involving human subjects is conducted in accordance with federal & state regulations as well as institutional policies. The IRB reviews protocols originating from:
- Any University Hospitals Health System entity involving UH patients or personnel, regardless of sponsorship.
- Case Western Reserve University School of Medicine, Nursing, Dentistry, or any department that involves patients or personnel at UH.
- Multi-site research conducted at non-UH sites, when requested by the entity, and when an IRB authorization agreement is in place.
Support Service Cores
- Research Support Core
The Research Support Core supports all phases of clinical research with expertise in every aspect of the clinical research process. As a fee-for-service team, this Core can provide flexible services based on the individual needs of each department or investigator and can begin at any point in the research trial.
Our services include study coordinator and research nurse staffing, recruitment support, community engagement, FDA support, regulatory support, and Biostatistical services.
- Dahms Clinical Research Unit
The Dahms Clinical Research Unit (DCRU) provides research-dedicated facilities and staff to create capacity, opportunity and a supportive environment for clinical and translational research at the academic medical center and in the community.
The DCRU team partners with investigators from all disciplines to support pediatric and adult clinical research visits and will work with investigators to plan study budget and implement protocol’s study visits.
- Clinical Research Business Development
The Clinical Research Business Development Office builds and maintains relationships with sponsors, UH departments, and researchers; connects PIs with new study opportunities; establishes and maintains researcher interest profiles, and provides concierge support for research staff. The office also manages the mandatory feasibility process before IRB submission and offers recruitment and protocol building assistance through TriNetX.
- Seidman Clinical Trials Unit
The mission of the University Hospitals Seidman Cancer Center Clinical Trials Unit is to provide the highest quality nursing, data, regulatory, financial and quality assurance services to our clinical investigators in an effort to provide an array of innovative clinical trials for the benefit of our patients.
Our vision is to be a comprehensive CTU, designed to be a one-stop-shop for investigators, sponsors and contract research organizations. The CTU is divided into functional teams (clinical, regulatory, data, finance and quality) grouped across the 12 disease teams, such that each team has a dedicated research nurse/research specialist partnership, regulatory, data and budget specialists.
Research Financial Cores
- Pre-Award Grants & Contracts
The Pre-Award Grants & Contracts office provides departmental support to all UH departments involved in clinical research. The office’s primary role is to review, negotiate, and execute clinical trial agreements and any other research-related agreements necessary to conduct clinical research. The office is also responsible for reviewing and negotiating clinical trial budgets and reviewing, approving, and submitting grants to foundations and local, state, and federal agencies.
- Research Finance Services
The Research Finance Specialist (RFS) team works with study teams to create a coverage analysis, which determines what research-related clinical items and services can be billed to insurance. Through this process, we build an effective study budget containing approved discounted research pricing and assist in sponsor budget negotiation. The RFS team completes research patient billing involving a participant’s claims, sponsor invoicing for patient care, and the collection of those funds owed by the sponsor.
- Post-Award Grants Accounting
The Post-Award Grants Accounting Team is responsible for all aspects of post-award grants management activities from grant account setup to close out (except research patient billing). The Post-Award team is responsible for creating grant accounts, review and approval of grant expenditures, reconciliation of grant awards including cash application and grant closeout, labor distribution and financial reporting. The team also works with the investigators, grant administrators, department administrators, finance, law department, corporate finance and Case Western Reserve University in the management of grants and contracts.