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Archive: Clinical Trials and the Sunshine Act
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.
- 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
The course will be led by one of the following instructors:
Elizabeth Ronk Nelson, M.P.H.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.