What goal is not part of a phase II safety study? a. Obtain preliminary safety d

Question

What goal is not part of a phase II safety study? a. Obtain preliminary safety data b. Obtain preliminary effectiveness data c. Investigate safety in limited number of patients Which of the following are key requirements of a clinical trial? a. Informed Consent b. IRB approval c. Product Development Protocol (PDP) d. All of the above e. a) and b) only Statement: "The labeling of an investigational device can be similar to the one of an already marketed device" a. This statement is true b. This statement is false

Explanation / Answer

5) Answer: C (Because phase II study involves large number of individuals (several hundred))

6) Answer: D (IPR approval is needed to go further for clinical trials and patients consent is needed to make them as a participant is the clinical trial)

7) Answer: B (A marketed device is already approved and that’s why labelled. But a device under investigation should not be labelled same as approved one until it is approved)

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