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The Sunshine Act Reporting for Clinical Trials
This training on Sunshine Act reporting for clinical trials will cover disclosure requirements for principal investigators and co-investigators under the Sunshine Act.
Payments made to clinical investigators participating in clinical trials need to be disclosed to CMS under the Sunshine Act provisions of the Patient Protection and Affordable Care Act of 2010, generally referred to as Obamacare. Under the new rules, principal investigators and co-investigators are subject to unprecedented disclosure requirements to the Center for Medicare and Medicaid Services (CMS).
These disclosures are in addition to the financial disclosure requirements to the FDA under IND regulations. Sponsors are required to collect detailed financial information and report to the CMS, which will verify it with the investigators, after which the information about each individual investigators will be made available on CMS's website to general public. Non-compliance could subject both the sponsors and investigators participating in clinical trials to hefty fines. This seminar will discuss the details of the processes; provide templates for reporting formats; and timelines for reporting. This seminar would also assist sponsors and investigators to develop standard practices to meet federal requirements.
Why Should you Attend:
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 seminar 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.
Objectives of the Presentation:
Clinical trial financial reporting requirements
Kind of payments covered and exempted for reporting to CMS
Format of reporting to CMS
Dealing with CMS's inquiries regarding reported information
Acceptable and Unacceptable practices
Comparison of Federal reporting requirements with Industry best practices
Legal and practical implications of reporting financial information for investgators
Regulatory solutions for most common anticipated issues with reporting.
Who can Benefit:
This webinar will provide valuable information to:
Principal and co-Investigators participating in industry-sponsored clinical trials
Sponsors of clinical trials
Legal experts involved in assisting physicians and patients alike with medical malpractice
Medical accounting companies
Senior management for companies developing new products for US market
Regulatory affairs professionals, research analysts
Financial analysts and investors, venture capitalists, insurance professionals
David Jonathan Moses