The Sunshine Act Reporting for Clinical Trials

This webinar will discuss the disclosure requirements for clinical investigators under the Sunshine Act. It will discuss the details of the processes; provide templates for reporting formats; and timelines for reporting.

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 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. This webinar would also assist sponsors and investigators to develop standard practices to meet federal requirements.

Areas Covered in the Webinar:

• 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 investigators
• Regulatory solutions for most common anticipated issues with reporting requirements

Who Will 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 of companies developing new products for US market
• Regulatory affairs professional and research analysts
• Financial analysts and investors, venture capitalists, and insurance professionals