Clinical Trials and the Sunshine Act: The Effect on the Clinical Research Industry

Upcoming Courses
Course #: BI12594
November 11, 2016
1:00 PM - 2:30 PM Eastern

Course Description

In an effort to increase transparency, highlight potential conflicts of interest, and ultimately decrease healthcare costs, one element of the Patient Protection and Affordable Care Act (PPACA) – the Sunshine Act – requires disclosure of payments or transfer of value to physicians. These physicians can also be involved in clinical research as Investigators, in which case additional information is required to be reported. Released in February 2013, the final rule requires applicable manufacturers of covered drugs, devices, and biological supplies to gather and report information to be listed on the public website. This web seminar will address the requirements for reporting of information derived from clinical research as well as exceptions for reporting.

Learning Objectives

  • Discuss who is “covered” and who is responsible for reporting
  • Describe the purpose and procedures for gathering and reporting information
  • Explore the effect on publication
  • Explain the impact on sponsors, Contract Research Organizations (CROs), Investigators, Institutions, and Institutional Review Boards (IRBs)
  • Examine timelines for reporting and extensions
  • Review timelines for obtaining and reporting information
  • Evaluate expectations for databases, record retention, and personnel
  • Consider challenges in complying with the requirements and consequences for noncompliance

Who Should Attend

  • Clinical Research Associates
  • Project Managers
  • Clinical Research Coordinators
  • Principal Investigators
  • Regulatory Affairs Professionals
  • Medical Affairs Professionals
  • All other personnel responsible for ensuring compliance with GCP regulations


Elizabeth Ronk Nelson, M.P.H.

Click here for complete trainer biographies  

Registration Fees


Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-15-056-L01-P. Released: 8/15. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.