Clinical Research Coordinating Center
Responsibility:
- To assure that only high-quality cancer clinical trials are undertaken at the University of Kentucky and that the conduct of clinical trials is of the highest possible quality.
- To adhere to National Cancer Institute (NCI) guidelines for Comprehensive Cancer Center designation by:
- Improving the quality & efficiency of the cancer clinical research review process
- Initiating a cancer clinical research quality assurance program
- Establishing a database to document cancer clinical research activity
- Improving communication across all cancer research programs
- Initiating a cancer research auditing program to monitor regulatory compliance.
CRCC External Newsletter - Spring 2008
Markey Research Overview SOP - (v2) 8/25/06
NCI's Definitions and Study Types - 10/30/06
Staff
John Rinehart, MD
Associate Director for Clinical Research
859-323-6522
Kristie Summers, CCRP
Assistant Director for Clinical Research
859-323-5127
Celeste Clevinger
Clinical Research Coordinator
859-323-8749
Katie Bugg
Clinical Research Coordinator
859-257-8213
Protocol Review Committee (PRC)
Responsibility:
To review cancer-related clinical trials for scientific design, priority and feasibility, excluding non-intervention trials. The PRC ensures that the study design will fulfill the objectives, and should help principal investigators of clinical trials optimize the scientific value of their study.
Protocol Review Committee (PRC) Submission Form - (v5) 6/24/08
PRC Annual Review Form - (v3) 10/23/06
Protocol Review Committee (PRC) SOP - (v1) 8/25/06
Quality Assurance Committee (QAC)
Responsibility:
Provides oversight and monitoring of the performance of all cancer-related clinical trials. It assures patient safety, protocol compliance and monitors accrual through conducting data and safety monitoring (DSM) reviews.
Additional Information
Can serve or assist the PI of investigator-initiated studies in the following:
- Data and Safety Monitoring Plan (DSMP)
- Selection and coordination of Data and Safety Monitoring Board (DSMB)/Data Monitoring Committee (DMC)
Contact Kristie Summers at 859-323-5127 if you are interested in using the QAC DSMP for your investigator-initiated study.
Quality Assurance Committee (QAC) SOP - (v1) 9/28/06
Oncore®
A cancer-specific system that provides fully integrated clinical data management and study administration capabilities. The Markey Cancer Center has implemented Oncore® as the study administration system to meet NCI requirements regarding comprehensive cancer centers.
Oncore Users Guide (v3) 8/10/07
Oncore SOP - (v1) 8/25/06
Onsemble
Internal Oncore Access Form (for UK Employees)
External Oncore Access Form (for External Study Staff)
MCC Clinical Studies Search
Markey Cancer Center Clinical Research Contacts
Gynecologic Oncology
Research Focus: Gynecologic cancers
Medical Director: John van Nagell, MD
Nurse Coordinator: Shar Ellixson
Phone: 859-323-3975
More information
Hematology, Oncology and Blood and Marrow Transplantation Clinical Research Program
Research Focus: Hematologic and solid tumor malignancies (breast, endocrine, gastrointestinal, genitourinary, head and neck, leukemia, lung, lymphoma, melanoma, myeloma, phase I studies, prostate, & sarcoma)
Medical Director: John Rinehart, MD
Manager: Valorie Gray, CCRP
Phone: 859-257-3379
MCC Clinical Studies Search
Lung Vaccine
Research Focus: Lung Cancer
Medical Director: Edward Hirschowitz, MD
Coordinator: Terry Foody, RN, MSN
Phone: 859-257-9575
Neurosurgery
Research Focus: Neurological/Brain cancers
Medical Director: Roy Patchell, MD and Byron Young, MD
Coordinator: Nurdan Ilgaz
Phone: 859-323-0375
More Information
Pediatric Oncology
Research Focus: Pediatric cancers
Medical Director: Jeffrey Moscow, MD
Research Nurse Coordinator: Jennifer Ballard, RN
Phone: 859-323-4659
More information
Radiation Oncology
Research Focus: Any cancer in which radiation therapy is used
Medical Director: Marcus E. Randall, MD
Manager: Jackie Sims, RTT
Phone: 859-323-1144
MCC Clinical Studies Search: Radiation Therapy
UKCRO
Research Focus: All types of clinical research studies
Assistant Director: Marietta Barton-Baxter, CCRC
Research Contact: Shirley Warren, CCRC
Phone: 859-323-8148
www.mc.uky.edu/ukcro/
MCC Clinical Studies Search
Marty Driesler Project
Research Focus: Esophageal, Lung and Liver in Kentucky's 5th District
Medical Director: Susanne Arnold, MD
Admin. Director: Bonnie Sigafus, EdD
Phone: 859-323-4715
martydrieslercancerproject.org
Kentucky Lung Cancer Research Project
Research Focus: Lung cancer epidemiology, diagnosis and treatment
Program Coordinator: Bonnie Sigafus, EdD
Phone: 859-323-4715
kentuckylungcancer.org
Kentucky Clinical Trials Network
Research Focus: Lung Cancer
Program Director: Kris Damron, CCRP
Phone: 859-323-1109
kyctn.org |
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