Food & Drug Regulation

Navigating Reporting Requirements on What You Need To Know Webinar

Presented by Mark Barnes
Recorded On: Thursday, November 08, 2012
Duration: 90 minutes
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By Phone: 1-800-677-3789

In this 90 minute webinar, Mark Barnes will explore the new results and adverse events reporting requirements of, and how these requirements are being applied by the FDA and NIH.  He will provide examples of problems with results reporting and address the best practices in applying the requirements to your own trials, so that you and your staff can comply with these complex new rules.

Questions to be Answered:

  • Who has the responsibility for reporting results and adverse events?
  • For what trials must results and adverse events be reported?
  • Are “registry studies” required to be registered and their results reported?
  • What data elements must be reported, and to what extent may sponsors and investigators define their own data elements for results reporting?
  • What data elements might be most appropriate for results reporting?
  • What are the key pitfalls and most common errors in results reporting, in randomized double-arm studies, cross-over studies, diagnostic studies and pharmacokinetic studies?
  • How and under what circumstances can there be permitted delays in reporting of results?  What is the process for application and approval for delayed reporting?
  • How do these requirements work in multi-center and international trials?
  • What are the penalties and risks in non-compliance? 
  • How do these requirements apply to federally-funded studies?

Who Should Attend:

  • Clinical affairs/regulatory affairs
  • Clinical trial investigators and coordinators
  • Clinical research associates
  • Compliance officers
  • Grants and contracts managers
  • Filings and documentation professionals
  • Executive management
  • General, corporate, and outside counsel
Mark Barnes
Mark Barnes is a partner at Ropes & Gray and practices in the areas of clinical trials regulation, research compliance, and federal research grants.  He has served at Harvard University as Senior Associate Provost for Research and as the University Chief Research Compliance Officer, and for the Harvard AIDS treatment programs in Nigeria, Tanzania and Botswana, he served as executive director during periods from 2004 until 2009.  Mark also has served as the Executive Vice President, Chief Administrative Officer and Director of Research Operations at St. Jude Children's Research Hospital, and has held senior appointed positions in the New York City and New York State Departments of Health. He currently co-chairs the Subcommittee on Harmonization of the HHS Secretary's Advisory Committee on Human Research Protections, which seeks to harmonize FDA, OHRP and other HHS research regulations, and is a member of the Ethics Working Group of the NIH HIV Prevention Trials Network. He holds faculty appointments and actively teaches at Yale School of Medicine and the Harvard Law School.