Clinical Research Office (CRO)

Kat Karelus

Katarzyna Karelus
CRO Administrative Director
katarzyna.karelus@case.edu

 

 

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Keralee Morey
DSTC Coordinator
moreyk@ccf.org

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Katherine Cherbow
DSTC Coordinator
katherine.cherbow@UHhospitals.org

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

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

Matthew Rump

Matthew Rump
OnCore Database
rumpm@ccf.org


This portal is intended as a resource for the clinical research programs of the Case CCC. 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


Announcements

Fall 2014 Case CCC Clinical Research Retreat
The Case CCC will be holding a Clinical Research Retreat on October 7 in the Wolstein Research Building. A reception will be held from 5-5:30 pm, followed by presentations from 5:30-7 pm.

The agenda will focus on the theme of Immunotherapy:

  • James Finke, PhD: Strategies to Reduce Immune Suppression as a Means to Improve Immunotherapy: A laboratory perspective
  • Joseph Baar, MD: Recent Advances in the Immunotherapy of Cancer
  • Shaveta Vinayak, MD: Tumor Infiltrating Lymphocytes Predict for Response to Therapy in Triple-negative Breast Cancer
  • Mitchell Machtay, MD: National Clinical Trials Network/Cooperative Groups (NCTN) Update

Pre-registration is required. Please contact Dr. Smitha Krishnamurthi (smitha.krishnamurthi@UHhospitals.org) with any questions. We hope everyone interested in clinical trials can attend!

Disease Team sign-off and PRMC Review and Approval
Message from: Neal Meropol, MD, Associate Director for Clinical Research; Robert Dreicer, MD, Deputy Associate Director for Clinical Research; Henry Koon, MD, PRMC Chair; and Jorge Garcia, MD, PRMC Co-Chair

The Protocol Review and Monitoring Committee (PRMC) will not be accepting protocol submissions without Disease Team sign-offs from both institutions. One of the functions of the Case CCC Clinical Trials Disease Teams is to "recommend action to PRMC for trial advocacy and priority" by providing "pre-review by experts in their field for scientific merit, prioritization, and intent to accrue patients" (Case CCC Clinical Trials Operations Manual). Disease Team sign-off from both hospitals has been a longstanding requirement and protocol submissions will no longer be accepted by PRMC without it. Please note that the overall responsibility of follow-up and obtaining sign-offs rests with the PI and the study team. Questions should be directed to April Firstencel, PRMC Manager, at 216.286.2294 or april.firstencel@case.edu.

Case CCC Protocol Templates Now Required
We have had great success with our year-long run-in period of using Case CCC protocol templates for investigator-initiated studies. Effective immediately, Case CCC protocol templates are mandatory when developing investigator-initiated protocols, and must contain all protocol template elements and language. These requirements will be enforced by the Case CCC Protocol Review and Monitoring Committee at the time of protocol submission and review. In the event that one or more elements of a trial do not fit into the template (e.g., a surgical trial or Phase 0 trial), the protocol should still retain the section(s) with a "Not Applicable" entered.

The Case CCC protocol templates (short and long versions) are available on the Case CCC website. They may also be accessed through links on the Clinical Research Portal or Clinical Trials Office. If you have any questions about the templates, please contact Katarzyna Karelus at 216.844.4176 or katarzyna.karelus@case.edu.

Registration of Clinical Trials and of Clinical Trials Results in 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 have to be registered and results have to be reported in ClinicalTrials.gov. More information is available at: http://prsinfo.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) is 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 for ClinicalTrials.gov has been registering applicable trials as well as clinical trial results in ClinicalTrials.gov on the investigators and study teams behalf. In order for the Case CCC to provide registration and reporting services, studies in the OnCore database must be updated in real time. In addition, it is expected that investigators and research teams, whose trials have been registered in ClinicalTrials.gov, will meet with the Case CCC Research Coordinator to discuss the process and information needed for reporting clinical trial results. Questions can be directed to Jan Hansonat 216.844.5060 or jan.hanson@case.edu.

We look forward to working with investigators and their teams to assure that we fulfill our results reporting obligations.

Importance of the OnCore Clinical Trials Management System Information
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. Questions regarding OnCore access, training and data entry can be directed to April Firstencel at 216.286.2294 or april.firstencel@case.edu.

Institutional Review Board (IRB)
The IRB review responsibilities are performed by the IRB offices and committees of the University Hospitals Case Medical Center (UHCMC) and the Cleveland Clinic (CC). All new cancer and cancer-related protocols are submitted to the IRB of the lead Principal Investigator's institution using their existing electronic systems (iMedRIS at UHCMC and WebKit at CC). The same procedures apply to amendments, continuing reviews, SAEs, deviations and other protocol-related actions.

It remains a high priority of the Case CCC to foster clinical research collaborations between the UHCMC and CC. To that end, the IRBs of each hospital accepts the approval of the other site in a facilitated review arrangement. Thus, opening of clinical trials at both sites requires only a single full board review at the site of the lead investigator. All cancer and cancer-related research protocols continue to be submitted to the Case Comprehensive Cancer Center Protocol Review and Monitoring Committee (Case CCC PRMC) for scientific review and approval, prior to review and approval by the respective institutional IRB.

If you have any questions or need more information about current processes, please refer to the following contacts:

UHCMC Cancer IRB
Website

Carol Fedor, RN, ND, CCRC, Clinical Research Manager
216.844.5524; carol.fedor@UHhospitals.org

SCC Clinical Trials Unit
Mary Bilancini, MS, Regulatory Manager, Seidman Cancer Center
216.286.6642; mary.bilancini@UHhospitals.org

Cleveland Clinic IRB
Daniel Beyer, MS, MHA, CIP
Ruth Fritskey, RN, MSN, AOCN
216.444.2924; irb@ccf.org

Taussig Cancer Institute
Becky Habecker, BS, CCRP, Research Program Manager
216.445.2612; habeckb@ccf.org

Case CCC Clinical Research Office (Case CCC CRO)
Katarzyna Karelus, Case CCC CRO Administrative Director
216.844.4176; katarzyna.karelus@case.edu