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31. What Are Sponsor Responsibilities?

The IRB expects the sponsors of trials to adhere to established ethical principals and monitor the conduct of the research in accordance with federal regulations.


Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND, maintaining an effective IND with respect to the investigations, and ensuring that the FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug. Sponsor Responsibilities



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