Module 1 2021

eCTD Structure Overview

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Sponsor Obligations

• Sponsor − Person who takes responsibility for an IND to initiate a clinical investigation − Signed off on Form FDA 1571 • General Sponsor Responsibilities: − Select qualified investigators; provide them with information they need to conduct investigation properly − Ensure proper monitoring of the investigation(s) − Ensure that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND − Maintain an effective IND − Comply with safety reporting requirements

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