Signatures on CV for Med. Device (IDE) Studies

[Jenn Leaning]

I was reading the FDA’s guidance on 1572s, which state that FDA regulations do not require a CV to be signed and dated because the Investigator’s dated signature on the 1572 is sufficient to attest to the accuracy of the CV.

… But Medical Device studies do not necessarily utilize a 1572…

So! My question was: in this situation where an IDE study does not have a form to attest to the accuracy of the Investigator’s CV, would the Investigators be required to sign and date their own CVs to confirm that its current and accurate? Or, would the Investigator Agreement act as the attestation…?

[Christy Nini]

Hi Jenn, I’m with medical device studies and our practice asks Investigators to sign and date their actual CV document.

[Author]

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