What are the sponsor’s responsibilities under the NIH Guidelines?

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What are the sponsor’s responsibilities under the NIH Guidelines?

April 26, 2017guidelines NIH responsibilities sponsor

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score 0 · Answer 1 · 2010-11-05T05:51:42+00:00

Sponsors are regulated mainly by the FDA, not the NIH, and the NIH Guidelines do not assign particular responsibilities to sponsors. The premise of the NIH Guidelines is that the researchers are responsible for biological safety, so the PI is the regulatory ‘touch point’ for the NIH.

What are the sponsor’s responsibilities under the NIH Guidelines?

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