Global Clinical Trial Disclosure and Data Transparency Conference

Untangle the complexities of global disclosure practices, learn about recent regulatory modernization, and discuss cross-regional strategic considerations.

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Session 4: Enforcement Initiatives by FDA and a UK Research Funding Agency

Session Chair(s)

Robert Paarlberg, MS

Principal

Paarlberg & Associates LLC, United States

Sponsors are required to register and report results of clinical trials according to regional laws and regulations. This session will focus on the enforcement initiatives by health authorities to ensure that sponsors are complying with clinical trial data disclosure requirements, while also highlighting the legal consequences of non-compliance. Note: Rachel Knowles will be participating virtually

Learning Objective : At the conclusion of this session, participants should be able to:
Describe the initiatives health authorities are taking to encourage compliance
Understand the potential civil and monetary penalties for non-compliance

Speaker(s)

ClinicalTrials.gov: Meeting FDA Registration and Reporting Requirements

Representative Invited

FDA, United States

Compliance with Funder Requirements for Clinical Trials Transparency

Rachel Knowles

Medical Research Council, United Kingdom

Lead for Clinical Research Policy, Ethics and Government