The UH Clinical Research Center consists of many core services with a commitment to support research teams.
- Research Compliance, Education & Outreach
The Office of Research Compliance, Education & Community Outreach (ORC) provides education and training to all members of the Clinical Research Community at UH. We offer required Clinical Research Orientation for the entire study team as well as Investigator Training which is required for Investigators with less than one year of experience.
- Pre-Award Grants & Contracts
The Pre-Award office, also known as the Grants and Contracts office, provides departmental support to medical departments throughout the hospital that are 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. In addition, this office is responsible for reviewing and negotiating clinical trial budgets.
In addition, the Pre-Award office is also responsible for reviewing, approving and submitting grants to foundations as well as 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.
- Regulatory & FDA Support
The Regulatory & FDA Support Core are well versed in the regulatory approval and startup processes of the FDA and IRB and provide regulatory support for the conduct, implementation, management, and monitoring of clinical research activities at UH. They can provide flexible services based on the individual needs of each department or investigator and can begin at any point in the research process. The Regulatory & FDA Support Core are also available to provide consultation services prior to the start of a clinical trial to assist investigators with their pre-clinical questions about new drugs, devices, or biologics, and provide guidance on the correct regulatory pathway with the FDA and IRB.
Biostatistical support services are available for UH faculty, investigators, and investigative teams as well.
- Coordinator Core
The Research Coordinator Core is a fee-for-service “float pool” of experienced research nurse and non-nurse coordinators. This core serves as a resource to investigators and their research staff at all UH sites; community-based and non-UH sites; and collaborates with other institutions as well.
- Dahms Clinical Research Unit (DCRU)
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 you to plan your study budget and implement your protocol’s study visits.
- The UH Seidman Cancer Center Clinical Trials Unit (CTU)
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 office 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 specialist, data specialist and budget specialist.
- Post-Award Grants Accounting
The Grants Accounting Post-Award Management Team is responsible for all aspects of post-award grants management activities at University Hospitals Cleveland Medical Center and all UH community hospitals from grant account setup to close out (except research patient billing) including creation of grant accounts, review and approval of grant expenditures, reconciliation of grant awards including cash application and grant closeout, labor distribution and financial reporting. The post-award team works with the investigators, grant administrators, department administrators, finance, law department, corporate finance and Case Western Reserve University in management of grants and contracts.
- 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.
- Technology Management
The Office of Technology Management is available to assist with all aspects of the creation, protection and commercialization of Intellectual Property generated by the University Hospitals community. Intellectual property can include patents, copyrights, trademarks, and trade secrets, with the first two of most importance in our setting.