Clinical Trials Disclosure and Reporting Compliance

Navigating Overlapping and Evolving Federal and State Transparency Requirements

Recording of a 90-minute CLE webinar with Q&A

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Conducted on Thursday, March 31, 2011

Recorded event now available

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Course Materials

This CLE course will provide guidance to counsel for navigating overlapping and evolving federal and state regulations and existing guidance for clinical trials disclosure and reporting. The panel will offer best practices to ensure transparency during clinical trials and avoid costly mistakes.


Federal and state enforcement agencies have increased disclosure and reporting requirements for clinical trials in an effort to heighten industry accountability and public trust.

Consequently, healthcare providers, pharmaceutical companies, and medical device makers conducting clinical trials must navigate myriad complex and evolving laws.

Counsel to these organizations must understand the interplay between federal and state transparency laws and guidance governing clinical trials and take steps to avoid or minimize liability for compliance shortfalls.

Listen as our authoritative panel of attorneys with clinical trials experience discusses the overlapping and evolving federal and state regulations and existing guidance for clinical trials disclosure and reporting. The panel will explain how counsel can prevent mistakes that could create liability exposure.



  1. Clinical trials overview
    1. Food and Drug Administration amendments Act of 2007 (FDAAA)
  2. Regulations and guidance related to clinical trial transparency
    1. State laws on disclosure (trends, key differences among states, key areas of dispute)
    2. Physician Payment Sunshine Act
    3. Other transparency legislation
    4. Conflict of interest legislation
  3. Corporate Integrity Agreements
  4. Current trends in foreign clinical trials


The panel will review these and other key questions:

  • How can counsel reconcile overlapping and sometimes divergent federal and state law requirements regarding clinical trial transparency?
  • What compliance best practices should be employed to increase the likelihood of meeting all reporting and disclosure requirements?
  • How can counsel help prepare their clients for the Physician Payment Sunshine Act that will soon take effect and other new transparency requirements currently being proposed?

Following the speaker presentations, you'll have an opportunity to get answers to your specific questions during the interactive Q&A.


Kristin H. West, J.D.
Kristin H. West, J.D.
Associate Vice President & Director
Emory University Office of Research Compliance
Eve M. Brunts
Eve M. Brunts

Ropes & Gray

She regularly advises clients on Medicare and Medicaid coverage, claims and payment requirements for a variety of...  |  Read More

Joseph P. McMenamin
Joseph P. McMenamin


He focuses on health-related litigation, including products liability and toxic torts, risk management and claims...  |  Read More

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