The Sunshine Act: Reporting for Clinical Trials
Duration : 60 Minutes
Sarah Fowler-Dixon, Clinical Research
Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new pr Read more
The Sunshine Act exposes the physicians and sponsors to new reporting requirements which are unprecedented in their scope and detail noncompliance to which would lead to hefty fines. This webinar will summarize the new requirements and provide practical solutions to most common situations that are prevalent and necessary between sponsors and investigators. Templates for reporting format, acceptable accounting practices, exemptions to reporting requirements and time-lines for compliance and enforcement will be discussed.
Course Objective:
The Sunshine Act, or Open Payments Program, requires manufacturers of drugs, medical devices, and biologics that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. This Act was part of a healthcare reform bill adopted in March 2010. It came about due to requests for increased transparency about the financial relationships between physicians and industry. The Centers for Medicare and Medicaid (CMS) issued the final rules in 2013 which implemented the Sunshine Act.
Course Outline:
• Purpose of the Sunshine Act
• Who is required to report under the Sunshine Act?
• What is reported?
• Exclusions
• Tracking
• Penalties
• Useful links
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Human Subjects Research
• Healthcare interested in exploring the field of Clinical Research
• Clinical Research Coordinators
• Principal Investigators/Physicians
• Administration in charge of Clinical Research
• Regulatory Compliance
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
