Clinical Research Administrative Office (CRAO)

Clinical Research Administration
CRO Administrative Director: Katarzyna Karelus kxk384@case.edu
PRMC Coordinator: David Goldblatt david.goldblatt@case.edu
DSTC Coordinators: Keralee Morey
Julie Herzog 		moreyk@ccf.org
juliann.herzog@UHhospitals.org
OnCore Database: April Firstencel
Bob Lanese		 april.firstencel@case.edu
bob.lanese@case.edu

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

Case CCC Clinical Research Retreat
There will be a Case CCC Clinical Research Retreat on April 4 in the Dively Building on CWRU campus. An opening reception will start at 5:30 pm, followed by dinner and presentations from 6-8:30 pm.

The agenda will focus on new initiatives of critical importance to clinical investigators. Topics will include:

  1. Description of our new N01 Consortium that provides opportunities to access investigational agents from NCI and conduct multicenter trials;
  2. Discussion of the Cancer IRB transition;
  3. Enhancements of clinical research operations, policies, and procedures;
  4. NIH regulations regarding clinical trial registration – PI responsibilities.

We hope everyone interested in clinical trials is able to attend! Pre-registration is required. Seating is limited, so register today.

Please contact Katarzyna Karelus (kxk384@case.edu) or Dana Rose (dana.rose@UHhospitals.org) with any questions.

Cancer IRB Transition
The IRB review responsibilities of Case Comprehensive Cancer Center Institutional Review Board (Cancer IRB) were transitioned to the IRB offices and committees of the University Hospitals Case Medical Center (UHCMC) on December 12, 2011 and to the Cleveland Clinic (CC) beginning on October 24, 2011. Approvals by the Cancer IRB will remain in effect until further review is undertaken by the UHCMC or CC IRB. All new cancer and cancer-related protocols will be 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 on currently active protocols that were processed and approved previously by the Cancer IRB. These activities will be reviewed by the IRB of the lead Principal Investigator’s institution which will be the IRB of record.

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 have agreed to accept 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 will 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 contact one of the following contacts:

Case CCC PRMC
David Goldblatt, Protocol Review & Monitoring Committee Manager
Phone: 216.844.5060
Fax: 216.201.4043
david.goldblatt@case.edu

UHCMC Cancer IRB
Website
Cheryl Gipson, Human Subject Protections Specialist
Phone: 216.844.7829
Fax: 216.844.1547
cheryl.gipson@UHhospitals.org

Carol Fedor, RN, ND, CCRC, Clinical Research Manager
Phone: 216.844.5524
Fax: 216.844.1547
carol.fedor@UHhospitals.org

SCC Clinical Trials Unit
Emily Collins, MA, CCRP, Regulatory Manager, Seidman Cancer Center
Phone: 216.844.5404
Fax: 216.844.1061
emily.collins@case.edu

Case CCC Clinical Research Office (Case CCC CRO)
Katarzyna Karelus, Case CCC CRO Administrative Director
Phone: 216.844.4176
Fax: 216.844.7832
kxk384@case.edu

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

Taussig Cancer Institute
Becky Habecker, BS, CCRP, Research Supervisor
Phone: 216.445.2612
habeckb@ccf.org

Case CCC Protocol Templates Mandatory By 1/1/2013
The Case CCC SOP protocol templates (short and long versions) are available on the Case CCC websites at: http://cancer.case.edu/researchadmin/forms/. They may also be accessed through links on the Clinical Research Portal or Clinical Trials Core Facility.

Effective immediately, protocol templates are considered a standard when developing investigator-initiated protocols which should contain all the necessary protocol template elements. Starting January 1, 2013, all investigators-initiated protocols will have to conform to the templates. Investigators are strongly encouraged to start using the templates as soon as possible and to provide feedback, so that the templates can be modified to better serve the needs of the Case CCC research community.

If you have any questions about the templates and/or to provide feedback, please contact Katarzyna Karelus at 216.844.4176 or kxk384@case.edu.

Case CCC Clinical Trials Protocol Specific Research Support Funding
The Case CCC is encouraging investigators to submit Letters of Intent for the Protocol Specific Research Support funding for Year 2012. The budgeted funds are for the conduct of early phase clinical trials and restricted to support research nurses and data managers directly involved in the conduct of these clinical trials. Studies developed jointly between UH and CCF with planned accrual at both institutions will be prioritized. Please direct questions and requests for information about the funding process to Katarzyna Karelus, Administrative Director, Case CCC Clinical Research Office, at 216.844.4176 or kxk384@case.edu.

Importance of the OnCore Clinical Trials Management System Information for Cancer Center Support Grant Renewal
As we commence the Cancer Center Support Grant renewal period, 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 forms a basis for our reporting capabilities for grant renewal purposes. Please make every effort to ensure that information on your studies in OnCore is complete. Please contact April Firstencel 216.286.2294 or april.firstencel@case.edu with any questions regarding OnCore access, training and data entry.

Case CCC Clinical Trials Standard Operating Procedures (SOPs)
The Case CCC has posted clinical trials Standard Operating Procedures (SOPs). SOPs apply to those members of the clinical research teams who are involved in conducting cancer research and clinical trials at the Case CCC. The Cancer Center implements and enforces all SOPs across consortium institutions: Case Western Reserve University, Cleveland Clinic and University Hospitals. Questions about the SOPs should be directed to Katarzyna Karelus, Administrative Director, Clinical Research Office, 216.844.4176 or kxk384@case.edu.

New Federal Mandate to Report Clinical Trial Results in clinicaltrials.gov
A new federal mandate, 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/.

The Case CCC Research Coordinator for clinicaltrials.gov has been registering applicable trials in clinicaltrials.gov on the investigators and study teams behalf. In the upcoming months, we will be contacting investigators and research teams whose trials have been registered in clinicaltrials.gov to obtain certain information and to assist investigators in reporting trial results.

Questions can be directed to April Firstencel at 216.286.2294 or april.firstencel@case.edu. We look forward to working with investigators and their teams to assure that we fulfill our results reporting obligations.