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This program will provide highlights of rules for financial disclosure in clinical trials. We will review FDA rules for submitting information about clinical investigators’ financial interest in clinical trials, HHS rules for disclosing financial conflicts of interest in Public Health Service funded research, and the requirements for sponsors to report payments made to physicians conducting research under Physician Payment Sunshine Act
The penalties for failing to report can be burdensome, including FDA’s refusal to accept a marketing application when appropriate financial disclosures are not made, and significant monetary penalties
Lunch will be provided.
Registration for this event is now closed.