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DoubleTree Bethesdan

Sep 19, 2019 7:00 AM - Sep 20, 2019 3:15 PM

8120 Wisconsin Avenue, , Bethesda, MD 20814 , USA

Global Clinical Trial Disclosure and Data Transparency Conference

Learn about the latest global requirements in clinical trial disclosure and data transparency, share best practices, and engage in in-depth discussions on hot topics.

Session 6: Overview of Disclosure Requirements for Federally Funded Trials

Session Chair(s)

Patrick  Fawcett

Patrick Fawcett

Information Disclosure Administrator, Office of Research Protections

University of Pittsburgh, United States

Obligations to publicly disclose clinical trial information are rooted in law, ethics and organizational policy. Like many other major funders of clinical trials research, the United States federal government has numerous such policies in place. This session will primarily focus on policies requiring disclosure of registration information, summary results information and/or study documents, and which apply to trials funded in whole or in part by the US government. These include: 1) NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information; 2) Revised Federal Policy for the Protection of Human Subjects (“Common Rule”); and 3) Other US Government Funding Agency Policies.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Identify the main disclosure policies applied to clinical trials funded by the US Government
  • Describe the who, what, when, and how of compliance with these policies
  • Compare the consequences of unfamiliarity and noncompliance with these policies


Anthony  Keyes, MBA, PMP

Overview of Disclosure Requirements for Federally Funded Trials: Anthony Keyes, MBA, PMP

Program Administrator, Clinical Research Operations

Johns Hopkins University, United States

Diane Lehman Wilson, JD, MA

Overview of Disclosure Requirements for Federally Funded Trials: Diane Lehman Wilson, JD, MA

Regulatory Affairs Manager

University of Michigan Medical School Office of Regulatory Affairs, United States

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