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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

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Question 1 of 8

1. Question
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.”
- True
- False
Question 2 of 8

2. Question
The required elements of Adverse Event reporting include the following:
- Description of the event, including start and stop dates.
- Treatment received/action taken.
- Causality.
- Expectedness.
- Principal Investigator initials and date.
- a, b, e.
- All of the above.
Question 3 of 8

3. Question
Adverse Event collection begins with participant consent and ends with the final study visit.
- True
- False
Question 4 of 8

4. Question
Key questions for assessing Adverse Event relatedness include the following:
- Was the AE present at baseline assessment or in recent medical history?
- Is the AE a known reaction to the study intervention?
- Does the participant believe the AE is related to the study intervention?
- Is the AE temporally associated with the study intervention?
- All of the above.
- a, b, d.
Question 5 of 8

5. Question
Severity and Seriousness of Adverse Events refer to the same considerations for reporting AEs.
- True
- False
Question 6 of 8

6. Question
Criteria defining Unanticipated Problems Involving Risks To Subjects or Others (UPIRTSOs) include the following:
- Unexpected relative to the research procedures described in the protocol and the characteristics of the study population.
- Research places subjects at a greater risk of harm than previously known or recognized.
- Listed as a potential risk at Consent.
- Related or possibly related to participation in the research.
- a, b, d.
- All of the above.
Question 7 of 8

7. Question
Types of FDA inspections include the following:
- Routine inspections.
- For-cause inspections.
- Data documentation inspections.
- Follow-up inspections.
- a, b, c.
- a, b, d.
Question 8 of 8

8. Question
Common documentation requested during FDA inspections includes all of the following except:
- Delegation of authority (DOA) logs.
- Form FDA 1572.
- Screening and enrollment logs.
- Budget and contract documents.
- Informed Consent Forms.

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The Data Coordinating and Operations Center (DCOC) is the component within the NIH Environmental influences on Child Health Outcomes (ECHO) Program that provides operational coordination for the ECHO IDeA States Pediatric Clinical Trials Network (ISPCTN). This coordination also includes technical instruction, data coordination as well as quality control and assurance.

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