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Adverse Events and FDA Inspections – Post Quiz

Adverse Events and FDA Regulations Adverse Events and FDA Inspections – Video & Post Quiz Adverse Events and FDA Inspections – Post Quiz

  1. An Adverse Event is defined as “All untoward or unfavorable medical occurrences in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, considered directly related to the subject’s participation in the research.”

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  2. The required elements of Adverse Event reporting include the following:

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  3. Adverse Event collection begins with participant consent and ends with the final study visit.

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  4. Key questions for assessing Adverse Event relatedness include the following:

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  5. Severity and Seriousness of Adverse Events refer to the same considerations for reporting AEs.

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  6. Criteria defining Unanticipated Problems Involving Risks To Subjects or Others (UPIRTSOs) include the following:

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  7. Types of FDA inspections include the following:

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  8. Common documentation requested during FDA inspections includes all of the following except:

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