Frequently Asked Questions

Yes, some facilities support inpatient and outpatient research in dedicated Clinical Research Units, for cancer and non-cancer research. The outpatient facilities span across Northeast Ohio.

UH is a comprehensive site, which encompasses a central research center (CRC). The CRC adds additional support to all types of studies at UH in addition to the support that comes from the departmental/specialty level. The CRC offers support throughout the research process, from pre-development to study close-out and publication. Some of these services include fee-for-service study support, including study coordinators, nurse coordinators, FDA submission support, and recruitment support. There are clinical research units available to use for research patient visits, lab storage, and lab processing services, all exclusive to conducting research. Additionally, the CRC has a Mobile Research Unit that assists with increasing accessibility and convenience to improve patient participation and engagement while enrolled in a study.

Yes, there are 11 beds and four chairs available for inpatient and outpatient visits, which accommodate both adult and pediatric research patients.

UH is one of the nation’s leading health care systems that provides the highest quality of patient-centered care and patient safety. UH has received numerous awards and recognitions from some of the most prestigious institutions in the country for our leadership and exceptional patient outcomes. The UH system has 1,032 beds, 18 hospitals, including three joint ventures, and 50+ ambulatory health centers. UH conducts 11 million outpatient procedures and discharges more than 142,000 inpatients annually. UH covers approximately 2.1 million patients’ lives. More than 28,000 physicians and employees constitute UH and its partnership hospitals, making it Northeast Ohio’s second-largest private-sector employer. UH Seidman Cancer Center, the region’s only freestanding cancer hospital, is devoted to treating cancer and hematologic disorders. UH Seidman is a founding member of the National Cancer Institute-designated Case Comprehensive Cancer Center. Fourteen disease teams focus on each type of cancer spanning Northeast Ohio, with 18 community-based cancer centers that cover the region.

Yes, the CRC implemented a mandatory feasibility process in late 2018. The scope of this process is to ensure that the study is feasible throughout the UH system, with emphasis on recruitment, site logistics, and financial resources for implementation and completion of the study. Investigators are required to complete the process before grant, IRB, or FDA submission. All investigators who would like to implement a research study that prospectively enrolls human subjects are required to undergo feasibility. Research projects, including sponsored research, clinical trials, and FDA regulated studies, are subject to this policy. Retrospective chart reviews, biorepositories, tissue and blood sample banking, exempt research, questionnaire studies, and behavioral research are all exempt from this requirement. If the research design includes elements that span both exempt (chart review) and non-exempt (FDA regulated), then the study must undergo feasibility.

The CRC was founded in 1996 and has become one of the largest biomedical research centers in Northeast Ohio, and one of the top 15 in the country. In 1962 before establishing the Clinical Research Center, UH was the first of 5 hospitals in the U.S. to have a hospital-based Clinical Research Unit that allowed investigators to see their research patients on a nursing floor. Currently, more than 2,600 active clinical studies are encompassing all specialties; more than 300 of these studies are cancer clinical trials.

Yes, our site has been establishing Master Confidentiality Agreements, and Master Clinical Trial Agreements with CROs to help streamline the site feasibility and identification process.

The IRB Administration is supported by IRB Specialists who pre-review all submitted studies before going to the full board. This service ensures that all study material is submitted correctly before having the committee review for the final determination.

Three committees meet on a bi-weekly basis. The M and J committees meet on rotating Tuesdays and review all non-cancer research studies. The C committee meets every other Thursday and reviews all cancer research studies.

Yes, our research site supports all study phases.

Yes, the CRC provides free biostatistical support and data analytics by request.

The CRC offers assistance with the recruitment of studies that are hard to enroll. We have a comprehensive recruitment workshop and toolkit available to all investigators and study teams to teach and assist them with the recruitment of research participants. We also offer free study population querying through TriNetX, which gives us the ability to re-identify patients within our system who meet the study criteria. Research IT requests are also available to gather specific information from the EMR for recruitment purposes.

The CRC has a Mobile Research Unit (MRU) that is unique to the region and is staffed by experienced coordinators. It provides accessibility and convenience to improve participant engagement and compliance. The MRU includes an exam table, phlebotomy chair, laptops/tablets, centrifuges, refrigerator and freezer, a dynamap machine, and a backup generator.

Yes, we have an Investigational Drug Services Pharmacy that administers all study drugs to the study team.

The CRC is a one-stop-shop that fully supports any research study at any phase of research, from pre-development to study close-out and publication.