New Faculty Orientation
August 22, 2012
UAMS Research Support Center
Director: Tom Wells
(501) 603-1638
[email protected]
Research Support Center
• Lawrence E. Cornett, PhD, Vice Chancellor for
• Tom Wells, MD, MBA, Director
• Carole Hamon, BS, Associate Director
• Julia Washam, RN, Associate Director
Research Support Center Services
Protocol development and review
Regulatory review and support (FDA)
Quality assurance (GMP, GLP)
Monitoring, DSMP, DSMB
Clinical trials registration
Budget review and assistance with budget
• Medicare coverage analysis
• Contract review, negotiation, and approval
Three Topics to Consider When
Planning Your Research
• Research vs. the practice of medicine
• Coverage analysis for tests and procedures in
research studies
• Clinical trial registration
Clinical Research vs.
Practice of Medicine
• FDA does not regulate the practice of medicine
• Arkansas State Medical Board does not regulate clinical
• For clinical care, physicians may prescribe “off-label” any
approved drug, biological, or medical device
• Approved drugs used in a new population or for a new
indication may require an IND if used in research
• Unapproved drugs and biologicals used in research
require an IND or an exemption
• Unapproved devices used in clinical research require an
IDE or other clearance from the FDA
Coverage Analysis
• Coverage analysis is a determination, based on CMS
rules, as to whether or not services that are normally
billable to patients can be charged to subjects enrolled
in a research study.
• Third party payors may or may not pay for services that
are provided as part of a research study even if those
same services would be billable as part of routine care
if the subject was not a research participant.
• At UAMS, all research studies that include medical
procedures, drugs, clinic visits, or laboratory studies
must undergo coverage analysis.
Public Law 110-85
Sec.801 Expanded Clinical Trial Registry
• Enacted on September 27, 2007
• Requires Trial Registration (Dec 2007)
– Phase II-IV drug and device trials for all diseases
– Data elements: + WHO/ICMJE
• Requires Results Reporting (Sept 2008)
– Trials of FDA-approved or cleared drugs and devices
– “Basic” Results: Baseline Characteristics, Primary &
Secondary Outcomes, Statistical Analyses
– Adverse Events (Sept 2009)
– “Expansion” of results by rulemaking (Sept 2010)
• Added enforcement provisions
Zarin DA, NLM Presentation, October 2009
Enforcement Provisions
• Notices of non-compliances
• Civil monetary penalties up to $10,000/day
• Withholding of NIH grant funds
Zarin DA, NLM Presentation, October 2009
ICMJE Policy
• Editorial 2004 and updates
• Registration required for manuscript
consideration for following:
– Interventional studies
– Any phase
– Any intervention
• or WHO Primary registry
• Registration prior to enrollment first
Zarin DA, NLM Presentation, October 2009
Clinical Trials Registration at UAMS
• The sponsor is required to register the trial
– Industry-sponsored and cooperative group trials
will be registered by outside entities (sponsors)
– Investigator-initiated trials meeting the above
criteria must be registered by UAMS (and the PI)
– RSC will help with registration
• If not registered properly, you may not be able
to publish your data
Final Thoughts
• Contact us if you are going to conduct
investigator-initiated research
• Research is NOT the practice of medicine; the
regulatory requirements are different
• We are not the Institutional Review Board nor
are we Research Compliance
• We are here to assist you in getting your
research up and running correctly
Research Support Center
Office: (501) 526-6876

Research Support Center