Exam Questions with 100% Correct
Answers | Latest Update
An adverse event should be reported to the IRB, IRO, or HUC within: -
🧠ANSWER ✔✔72 hours
What oversight person, group, or mechanism has the authority to suspend
or end an approved investigation? - 🧠ANSWER ✔✔IRB, IRO, or HUC
Who is responsible for writing the clinical investigation (CI) research
protocol? - 🧠ANSWER ✔✔Principal investigator (PI)
As the principal investigator (PI), you are in charge of selecting and
appointing a medical monitor for the clinical investigation (CI) program. Of
the following candidates, who would be the best person for the job? -
🧠ANSWER ✔✔A nurse who has expertise in areas of patient management
and safety
What is the most critical aspect of carrying out a clinical investigation? -
🧠ANSWER ✔✔Informed consent
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