Sunday, September 17
9:00 AM – 11:45 AM
PRE-CONFERENCE:
CONCURRENT BREAKOUT SESSIONS
S1 Research Compliance 101
Rory Jaffe, Executive Director, Medical Services, University of California
Julianne Tenney, Associate Dean for Compliance, Duke University
Document 1, Document 2, Document 3, Document 4
- What’s special about research? Will you know it if you see it?
- Elements of an effective compliance program (New and Improved?!)
- What should you worry about most? . . . and how to respond if your
worries become real
S2 Training for Clinical Research
Samuel Tilden, Deputy Provost, Research Compliance Officer & Professor, University of Alabama
Carolyn P. Whitmire, Research Compliance Manager, University of Alabama
Gary Eiland, Partner, Vinson & Elkins LLP
Document 1
- Key operational steps in clinical trials and the financial process
- Compliance guidelines for allocating costs and billing in clinical trials
- Tips for avoiding False Claims Act and anti-kickback violations in
clinical trial settings
S3 Auditing and Monitoring for Grants
Tim Fournier, Chief Compliance for Northwestern University
Phyllis Hall, Director, Internal Audit Department, St. Jude Children’s Research Hospital
Document 1, Document 2
- Time & effort reporting
- Properly allocating charges to award projects (including cost transfers)
- Reporting financial support from other sources
1:00 – 4:00 PM
CONCURRENT BREAKOUT SESSIONS
S4 The Laws and Regulations Governing Clinical
Research 101
John Steiner, Chief Compliance Officer, University of Kentucky
Mark Waxman, Partner, Foley & Lardner
Gretchen Brodnicki, Director of Research Compliance,
Beth Israel Deaconess Medical Center
Document 1
- Key federal laws designed to protect patients
- What federal laws affect payment to clinical sites?
- The alternative structures—subgrants and collaborations
- How to handle the oversight and compliance responsibility
S5 Auditing & Monitoring
Lynda Hilliard, Senior Manager, Life Science & Healthcare Regulatory
Services, Deloitte & Touche LLP
Michelle Anderson, Senior Consultant, Life Sciences & Healthcare Regulatory, Deloitte & Touche LLP
Document 1
- Understand the focus of the OIG on clinical research and incorporate
high risk review areas into audit and monitoring plan
- List the core components of an ongoing and effective clinical research
audit and monitoring plan
- Integrate clinical research audit and monitoring activities into
organization-wide audit plan
S6 Human Subjects Protection 101
Melissa Markey, Attorney, Hall, Render, Killian, Heath & Lyman, PLLC
David Forster, Assistant Vice President of Compliance,
Western Institutional Review Board
Document 1, Document 2
- Basic requirements for a human subject protection system
- Current issues in research compliance
- Review of emerging issues
4:15 PM – 5:15 PM
How CMS’s Anticipated Update to the Clinical
Trials NCD Will Affect You
Lisa Murtha, Managing Director, Huron Consulting
Ryan Meade, Meade & Roach
Document 1
- Updates on CMS’s Reconsideration of the Clinical Trials NCD and
insights on how coverage policy may be revised
- Learn strategies to handle clinical trials billing compliance during the
reconsideration period
- Discuss how to build clinical trials billing compliance infrastructure
that is flexible to changing rules
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