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July 18, 2008

Clinical Research Fiscal Compliance Updates

New materials and tools are now available on the Corporate Compliance SharePoint site to assist you in conducting fiscally compliant clinical trials. These materials address recent changes in Medicare requirements and recently developed UKHealthCare forms. Additionally, you can contact Rebecca Scott, rmwalt00@email.uky.edu, 323-1478, with questions or comments.

Updates

• Medicare Coverage Analysis: Clinical Research Coordinators and Principal Investigators must complete a Medicare Coverage Analysis for any clinical research trial that is not 100% covered by the study/trial budget and involves billing a third party payor. You can visit the Corporate Compliance SharePoint site to access the Medicare Coverage Analysis form as well as a sample Research vs. Standard of Care worksheet.
• Clinical Research Billing Modifiers: The Center for Medicare and Medicaid Services (CMS) issued two new modifiers for use when submitting claims involving Medicare beneficiaries as clinical research participants. The two new modifiers, Q0 and Q1, replace the old QA, QV and QR modifiers. For information and instructions on the use of the new modifiers, please visit the Corporate Compliance SharePoint site.
• SCM Access: Coordinators and appropriate clinical research trial staff can obtain view access to SCM. Order entry access is available to appropriately licensed researchers. If you or a member of the study team need access, please visit the UKCRO fiscal compliance page and complete the appropriate forms.
• Research Plan Codes: The UKHealthCare enterprise is moving away from institutional accounts for clinical research trials and toward the use of research plan codes. To request a research plan code for new clinical research trials, please complete the Research Plan Code Create Form.
• Fiscal Compliance Training: Fiscal Compliance Training is required for all new College of Medicine providers who will be involved in clinical research trials. To schedule training, please contact Rebecca Scott, rmwalt00@email.uky.edu, 323-1478. Faculty and staff who do not have research responsibilities do not need to complete this training.

“A Paradigm for Cancer Selective Apoptosis” - Aug. 7

All are invited to attend the Dean’s Distinguished Lecture Series
Noon to 1 p.m.
Thursday, August 7, 2008

Vivek Rangnekar, Ph.D., Professor, Radiation Medicine, University of Kentucky

Objectives:

1. Define tumor suppression function, and delineate the role of pro-apoptotic tumor suppressors in the inhibition of tumor growth.
2. Demonstrate the importance of concurrent activation of pro-apoptotic pathways and suppression of cell survival pathways for cancer cell apoptosis and tumor regression.
3. Review the translational significance of tumor resistance in a mouse model.

Lunch available at 11:30 a.m. Presentation begins at Noon.

Please RSVP by 8/4/08 to Jessica Wehle, gcrc@email.uky.edu. If you require special physical arrangements to attend this meeting, please call 323-0598

Sponsors: C. William Balke, M.D., Associate Provost for Clinical and Translational Science and Dr. Jay A. Perman, M.D., Dean, College of Medicine.

Clinical Research Coordinator 101 - Aug. 20 - Oct. 22

Now enrolling for the Fall 2008 Clinical Research Coordinator 101 offering. Fax registration form (pdf) to 257-1563 by August 8, 2008.

This classroom based training is designed for clinical research coordinators, clinical research associates or staff who function in this capacity. The multi-session series provides basic information on coordinating clinical trials appropriate for entry-level positions or those new to the field. This training is designed as an entry-level program and does not currently provide continuing education credit.

Primary Instructor: Belinda Smith, MS, RD, CCRC, Research Education Specialist, Office of Research Integrity

Class Schedule: Wednesdays, 10 a.m. – Noon, Aug. 20 – Oct. 22

Presented by UK Clinical Research Development and Operations Center and UK Office of Research Integrity

Questions? Contact UK CR-DOC 323-8545 or ukcro@email.uky.edu.

Human Research Protection Conference - Sept. 26

To All University of Kentucky Research Investigators, Research Staff, and Study Personnel: Registration Now Available!

Click here for a pdf of the registration form and agenda for the UK Human Research Protection Conference to be held at Covington on September 26, 2008.

We sincerely hope that all of you can attend this important conference. This year’s program truly offers a topic of interest to all involved in human subject research and in addition, attendance will satisfy the UK mandatory human research protection continuing education requirement.

Register early and save! A limited number of reduced cost registrations are available. See brochure for details.Note that PAYMENT for registration may be made by check (payable to the University of Kentucky) or credited to cost center 1013200030-530503 after the conference has taken place. PAYMENT for CME/Nursing credit may be made by check only (payable to the University of Cincinnati).

Email your campus address to belinda.smith@uky.edu to receive a hard copy brochure.