The Sunshine Act: Reporting for Clinical Trials

Duration: 90 Minutes
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.
The Sunshine Act
Instructor: Sarah Fowler Dixon
Product ID: 502017
Objectives of the Presentation
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
Why Should you Attend
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 will Benefit
This webinar will provide valuable assistance to all personnel in:
  • 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
$375
Recorded Session for one participant
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Live Session - How it works
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  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Sarah Fowler-Dixon, PhD, CIP is an 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 program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities.

She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she led a task force in the development of the Community Engaged Research Program at Washington University. Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook.

Prior to joining Washington University, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.
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