Noncompliance is an action by the investigator, or member of the research team, that disregards federal regulations, IRB requirements, or institutional policies and procedures.
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Q5: For a study to be categorized as
Q6: A study that uses medical chart reviews
Q7: In healthcare research, studies that have significant
Q8: If informed consent cannot be documented (e.g.,
Q9: Any and all problems that occur during
Q11: It is the responsibility of the primary
Q12: The principle investigator (PI) typically inactivates the
Q13: An example of FDA-Regulated research would include
Q14: The Common Rule requires IRB approval of
Q15: The convened IRB (i.e., the full committee)
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