Clinical Training 2011 - FDA's 2011 Draft Guidance on Financial Disclosure by Clinical Investigators

This webinar will help you understand FDA’s draft guidance on financial disclosure by clinical investigators and show how financial information should be disclosed to FDA.

Earlier this year (Spring 2011), FDA released its draft guidance to replace its current guidance on disclosure of financial interests held by clinical investigators, 21 CFR 54. The draft guidance reflects the changing landscape both within and outside FDA regarding transparency of financial interests. Consistent with increased public attention to physician-industry ties and connections, the tone of the guidance suggests or infers that clinical trial sponsors should expect a more rigorous review by FDA of these financial arrangements.

This Webinar will highlight the main changes proposed by the draft guidance that sponsors should consider as they select clinical trial investigators, design their studies and prepare the financial disclosure information to be submitted in the marketing applications to FDA.