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While reviewing site records during a monitoring visit, a monitor can cite which of the...

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While reviewing site records during a monitoring visit, a monitor can cite which of the following as a site violation of informed consent regulations?

A.

A subject’s signature is missing on the copy of the summary of the short form consent

B.

A copy of the consent document was not provided to a subject

C.

Only the signatures of the person obtaining consent and the witness appear on the copy of the summary of the short form consent

D.

The sponsor-generated informed consent template is missing required elements

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