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Case Comprehensive Cancer Center

Clinical Research Office

Clinical Research Office

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.

Resources

Case CCC Clinical Trials Operations Manual

Case CCC Standard Operating Procedures - July 2016

Data and Safety Monitoring Plan‌- DSMP- Contact Katarzyna Karelus (katarzyna.karelus@case.edu) for individual DSMP Appendices

Case CCC Clinical Research Brochure

Protocol Templates

Cultural Competency Training

Announcements

(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. 

Please direct any questions and/or submit LOIs to Katarzyna Karelus, Case CCC Clinical Research Office, katarzyna.karelus@case.edu216- 844-4176

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.  

ClinicalTrials.gov

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; jan.hanson@case.edu

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
216.844.5524; carol.fedor@UHhospitals.org

Cleveland Clinic IRB

Ruth Fritskey, RN, MSN, AOCN
216.444.2924; irb@ccf.org

 

Staff

Katarzyna Karelus

Katarzyna Karelus, MS, MBA
CRO Administrative Director
katarzyna.karelus@case.edu

April Firstencel

April Firstencel
Protocol Review & Monitoring Committee Manager (PRMC); OnCore Support
april.firstencel@case.edu

Jan Hanson

Jan Hanson
Registration Coordinator for NCI CTRP and ClinicalTrials.gov; OnCore Support
jan.hanson@case.edu

Bob Lanese, MS

Bob Lanese, MS
OnCore Database
bob.lanese@case.edu

Keralee Morey
DSTC Coordinator
moreyk@ccf.org

 

Simona Pasca
DSTC Coordinator
simona.pasca@uhhospitals.org

Matthew Rump
OnCore Database
rumpm@ccf.org