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Shared Resources
Clinical Trials Core Facility
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Director:
Smitha S. Krishnamurthi, MD |
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Resources
- Clinical Research Portal
- OnCore Clinical Trials Management System
- Orientation
- Case CCC Clinical Trials Operations Manual (formerly RedBook)
- Case CCC Data Safety and Monitoring Plan- Contact Katarzyna Karelus at kxk384@case.edu for individual DSMP Appendices
- Case CCC Standard Operating Procedures (PDF)
- Protocol Templates
- Cultural Competency Training
- U.S. Department of Health and Human Services, Office of Minority Health: A Physician's Practical Guide to Culturally Competent Care (a free online cultural competency program for physicians)
- Cultural Competency Training is available for Cleveland Clinic employees through the Cleveland Clinic Office of Diversity and Inclusion and for University Hospitals employees through the online Learning Management System (access via UH Intranet home page, click on Human Resources, then click on Employee Direct Access, see "2012 Resident Orientation Cultural Competency").
- RTOG conducted a session on Cultural Competency and Recruitment Training in June 2011, which is available on the RTOG website. The session consists of four modules, of which the most useful may be module 3 consisting of several role-playing scenarios that emphasize principles important to recruitment of underserved populations.
Services
This core facility provides investigators with a broad range of services to assist in the initiation and conduct of clinical trials. Services include the following:
- Regulatory
- Facilitating approval of clinical trial agreements by appropriate hospital and university departments
- Budget preparation and review
- Negotiation of budget with pharmaceutical companies
- Protocol-related nursing care for patients on Phase I and II protocols, including eligibility screening, clinical assessment and follow-up, phlebotomy, pharmacokinetics and real time specimen preparation and monitoring of serious or adverse events
- Data management services, including verification of patient eligibility, completion of case report forms, and completion of flow sheets and forms required by the NCI, the Cancer Center or other regulatory agencies; follow-up data collection after completion of the treatment phase
- Quality Assurance
- Education for investigators and clinical trial staff
- Other services
Acknowledgement
Remember to acknowledge the valuable services provided by Cancer Center Core Facilities in your research papers and publications:
"This research was supported by the Clinical Trials Core Facility of the Case Comprehensive Cancer Center (P30 CA43703)."
Contact Information
Location: Wearn and Lakeside buildings
Director: Smitha S. Krishnamurthi, MD
216.844.3951
ssk7@case.edu
Director, Clinical Trials, UH/SCC: Melissa Kadar
216.286.6639
fax: 216.844.1042
melissa.kadar@UHhospitals.org
Research Administrator/Finance Manager, CCF: Denise R. Dawson
216.445.7171
fax 216.444.8685
dawsond2@ccf.org