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INSTITUTIONALREVIEWBOARD THE UNIVERSITY OF UTAHInvestigatorGuidanceSeriesINVESTIGATORRESPONSIBILITIESFORDEVICE STUDIES FederalResearchRegulations TheFDAisresponsibleforregulatingdevicesforhumanuse.

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What is investigator responsibilities for device studies?

Investigator responsibilities for device studies include conducting the research in compliance with regulations, ensuring the safety and well-being of study participants, and accurately collecting and reporting data.

Who is required to file investigator responsibilities for device studies?

Investigators who lead or participate in device studies are required to file investigator responsibilities for device studies.

How to fill out investigator responsibilities for device studies?

Investigators can fill out investigator responsibilities for device studies by providing detailed information about their role in the study, their qualifications, and any potential conflicts of interest.

What is the purpose of investigator responsibilities for device studies?

The purpose of investigator responsibilities for device studies is to ensure that research involving devices is conducted ethically and in compliance with regulations to protect the safety and rights of study participants.

What information must be reported on investigator responsibilities for device studies?

Investigators must report their qualifications, any financial or personal relationships that could create a conflict of interest, and their commitment to conducting the study in accordance with regulations.

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