This portal is intended as a resource for the clinical research programs of the Case Comprehensive Cancer Center. The portal gives researchers access to the necessary forms and information about the requirements to conduct clinical research as well as links to a number of useful sites.
Cultural Competency Training
- U.S. Department of Health and Human Services, Office of Minority Health: A Physician's Practical Guide to Culturally Competent Care (a free online cultural competency program for physicians)
- Cultural Competency Training is available for Cleveland Clinic employees through the Cleveland Clinic Office of Diversity and Inclusion and for University Hospitals employees through the online Learning Management System (access via UH Intranet home page, click on Human Resources, then click on Employee Direct Access, see "2012 Resident Orientation Cultural Competency").
- Radiation Therapy Oncology Group (RTOG) Cultural Competency and Recruitment Training Program from June 2011. The session consists of four video modules, of which the most useful may be module 3 consisting of several role-playing scenarios that emphasize principles important to recruitment of underserved populations.
(NEW) Request for Proposals for Case CCC Funding for Pilot/Phase I Clinical Trials
The Case CCC is encouraging investigators to submit Letters of Intent (LOI) for Early Phase Clinical Research Support (EPCRS) funding. These in-house funds are available for the conduct of early phase clinical trials of relatively short duration. Priority will be given to trials which are developed jointly between UH and CCF with planned accrual at both institutions.
The proposals are being accepted on a rolling basis subject to availability of funds.
Protocol Review and Monitoring Committee (PRMC)
Disease Team Sign-off
The PRMC will not accept protocol submissions without Disease Team sign-offs from both institutions. Please note that the overall responsibility of follow-up and obtaining sign-offs rests with the Principal Investigator and the study team.
Case CCC Protocol Templates
Case CCC protocol templates are mandatory when developing investigator-initiated protocols, and must contain all protocol template elements and language.
The U.S. Public Law 110-85 (Food and Drug Administration Amendments Act of 2007), Title VIII, Section 801, mandates that certain clinical trials must be registered, and results must be reported in ClinicalTrials.gov. In addition, the International Committee of Medical Journal Editors (ICMJE) requires that any intervention type of clinical trial (drugs, biologics, devices, surgical, behavioral or other) be registered in ClinicalTrials.gov PRIOR to registration of the first patient. Editors of the ICMJE will not consider publication of manuscripts if trials are not registered completely and prospectively. The Case CCC Research Coordinator registers applicable trials as well as clinical trial results in ClinicalTrials.gov on the behalf of investigators and study teams. Questions should be directed to Jan Hanson, Research Coordinator, 216.844.5060; firstname.lastname@example.org.
Importance of the OnCore Clinical Trials Management System
It is critical that investigators and study staff ensure that research study information, including accrual data, is being entered into the OnCore database on an on-going basis. Accurate and timely information in OnCore serves as a basis for Case CCC tracking and reporting capabilities. Please make every effort to ensure that information on your studies in OnCore is complete.
Institutional Review Board (IRB)
The IRB review responsibilities are performed by the IRB offices and committees of University Hospitals Case Medical Center and Cleveland Clinic. All new cancer and cancer-related protocols must be submitted to the IRB of the lead Principal Investigator's institution. The same procedures apply to amendments, continuing reviews, SAEs, deviations and other protocol-related actions.
University Hospitals Case Medical Center Cancer IRB
Carol Fedor, RN, ND, CCRC
Cleveland Clinic IRB
Ruth Fritskey, RN, MSN, AOCN