The site investigator receives a copy of an expedited safety report that represents an increased risk to the study participants.

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Sunny_sXe [5.5K]

3 years ago

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The site investigator receives a copy of an expedited safety report that represents an increased risk to the study participants.

A. File it in regulatory binder. B. Report to local IRB. C. Inform all participants. D. All of the above.

Social Studies

1 answer:

sukhopar [10] · Answer 1 · 2022-11-29T13:00:49+03:00

As a site investigator who receives a copy of an expedited safety report that represents an increased risk to the study participants, you need to Report to local IRB.

<h3>Who is a Local IRBs/IECs?</h3>

Local IRBs/IECs can be regarded as personel that serves at academic institutions and helps in conducting research and review only their trials.

Therefore, option B is correct because the copy of the expedited safety report represents an increased risk to the study participants .

Learn more about site investigator at:

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