Bob Lanese, MS
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.
Disease Team sign-off and PRMC Review and Approval
Message from: Neal Meropol, MD, Associate Director for Clinical Research, and Robert Dreicer, MD, Deputy Associate Director for Clinical Research
Effective immediately, Protocol Review and Monitoring Committee (PRMC) approval will not be granted if Disease Team sign offs are not on file in the PRMC study file.
One of the functions of the Case CCC Clinical Trials Disease Teams is to "recommend action to PRMC for trial advocacy, 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 is a longstanding requirement, but the PRMC has sometimes reviewed protocols without this sign off.
Please note that the overall responsibility of following-up and obtaining sign-offs rests with the PI and the study team. The PRMC will continue to send PRMC sign off forms to both hospital Disease Team leaders; however, PRMC staff are not responsible for obtaining the signatures – this falls with the PI.
Questions should be directed to Katarzyna Karelus, Clinical Research Office Administrative Director, email@example.com, 216.844.4176.
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 Core Facility. If you have any questions about the templates, please contact Katarzyna Karelus at 216.844.4176 or firstname.lastname@example.org.
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 April Firstencel at 216.286.2294 or email@example.com.
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 firstname.lastname@example.org.
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
Carol Fedor, RN, ND, CCRC, Clinical Research Manager
SCC Clinical Trials Unit
Mary Bilancini, MS, Regulatory Manager, Seidman Cancer Center
Cleveland Clinic IRB
Daniel Beyer, MS, MHA, CIP
Ruth Fritskey, RN, MSN, AOCN
Taussig Cancer Institute
Becky Habecker, BS, CCRP, Research Program Manager
Case CCC Clinical Research Office (Case CCC CRO)
Katarzyna Karelus, Case CCC CRO Administrative Director