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.
Case CCC Standard Operating Procedures [updated April 2017
Case CCC Data and Safety Monitoring Plan [updated February 2017]
Contact Katarzyna Karelus at firstname.lastname@example.org for individual DSMP Appendices.
(NEW) Protocol Eligibility Criteria
Case CCC PRMC would like to remind investigators of investigator-initiated studies to carefully consider each criterion in the eligibility section of the protocol and whether it is necessary for a particular study. Every effort should be made to broadly define eligible patients, and only exclude those patients for whom there is risk associated with mechanism of action of the treatment(s) and known/expected toxicities.
PRMC has included in the treatment protocol template information about the importance of making the eligibility criteria as liberal as possible. Eligibility criteria should not be a copy and paste function from a protocol to a protocol. PRMC reviewers and members will examine the eligibility section to ensure that the criteria are appropriately inclusive.
Case CCC protocol templates are mandatory when developing investigator-initiated protocols, and must contain all protocol template elements and language.
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.
(NEW) Reminder Regarding Submission of Verification and Confirmation Documents on Independent Review of Patients’ Responses on Investigator-Initiated Clinical Trials
The Case CCC DSTC would like to remind Principal Investigators and research teams about the process for confirmation of responses for Case CCC investigator-initiated trials and the Case CCC DSTC review and oversight of the process.
The process of verification and confirmation of responses is described in detail in the recently revised Case CCC SOP#: SM-6.2.0: Verification and Confirmation of Independent Review of Patients’ Responses on Investigator-Initiated Clinical Trials.
The process of submission of documents to the DSTC is described in the Case CCC SOP #: DSTC/DSM-7.1.0: Submission of Documents to the Data Safety and Toxicity Committee, section 5.4.
Both SOPs can be accessed in the Archive - Case CCC Standard Operating Procedures December 2016.
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, email@example.com, 216.844.4176.
Importance of 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.
NEW: As of January 8, 2017 the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) was put into effect. Protocol document with amendment summaries is now required with results reporting to ClincalTrials.gov. Additional information including statistical analysis is also required. More info available: https://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. 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.
IRB Required Review
The IRB responsibilities are performed by the IRB offices and committees of University Hospitals Cleveland 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 Cleveland Medical Center Cancer IRB
Beth Hagesfeld, MA, CCRP
Cleveland Clinic IRB
Ruth Fritskey, RN, MSN, AOCN