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The Sunshine Act: Reporting for Clinical Trials
This webinar will provide valuable assistance to all personnel in:
- Purpose of the Sunshine Act
- Who is required to report under the Sunshine Act?
- What is reported?
- Exclusions
- Tracking
- Penalties
- Useful links
Overview of the webinar
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.
Who should attend?
- 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
Why should you attend?
Anyone required to adhere to the Sunshine Act standards or anyone interested in knowing what must be reported and made public.
Faculty - Miss.Sarah Fowler Dixon
Sarah Fowler-Dixon, PhD, CIP currently works with the human research protection program at 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, guidelines, reporting, and training for researchers and staff. She often works with state and federal authorities such as the NIH and FDA. She has provided consultation regarding ethical, federal, state, and institutional requirements in the design and execution of projects. Dr. Fowler-Dixon teaches research ethics and regulatory affairs, the fundamentals of clinical research management and mentors honors students in the Clinical Research Management program.