All serious adverse events (SAEs) must be reported to the research...

All serious adverse events (SAEs) must be reported to the research site's Institutional Review Board (IRB).

A. TRUE

B. FALSE

2 Who can report an adverse event (AE)?

A. Participant

B. Participant's spouse

C. Caregiver

D. Participant's family member

E. Research Nurse

F. All of the above can report an AE

3 The severity of an adverse event (AE) is the same as its seriousness

.A. TRUE

B. FALSE

4 For participants discontinuing participation in a study because of a serious adverse event (SAE) or pregnancy, which of the following are correct?A. There should be an attempt to follow up the outcome of the pregnancy to term in cases of women discontinuing because of pregnancy.

B. There should be an attempt to comAll serious adverse events (SAEs) must be reported to the research site's Institutional Review Board (IRB).

A. TRUE

B. FALSE

2 Who can report an adverse event (AE)?

A. Participant

B. Participant's spouse

C. Caregiver

D. Participant's family member

E. Research Nurse

F. All of the above can report an AE

3 The severity of an adverse event (AE) is the same as its seriousness.

A. TRUE

B. FALSE

4 For participants discontinuing participation in a study because of a serious adverse event (SAE) or pregnancy, which of the following are correct?

A. There should be an attempt to follow up the outcome of the pregnancy to term in cases of women discontinuing because of pregnancy.

B. There should be an attempt to complete any final evaluations required by the study protocol.

C. There should be an attempt to perform other medical evaluations to try to determine the cause of the serious adverse event (SAE) and its possible relationship to the study intervention.

D. The serious adverse event (SAE) should be marked as resolved on the date of discontinued participation since the participant may not be evaluated again in the future.

E. A, B, and C only

F. All of the above are correct.

5 Examples of adverse events (AE) include which of the following?

A. Damaged wheelchair.

B. Anxiety.

C. Decreased blood sodium.

D. Enlarged thyroid on physical examination.

E. B, C, and D only

F. All the above are adverse events (AEs).plete any final evaluations required by the study protocol.

C. There should be an attempt to perform other medical evaluations to try to determine the cause of the serious adverse event (SAE) and its possible relationship to the study intervention.

D. The serious adverse event (SAE) should be marked as resolved on the date of discontinued participation since the participant may not be evaluated again in the future.

E. A, B, and C only

F. All of the above are correct.

5 Examples of adverse events (AE) include which of the following?

A. Damaged wheelchair.

B. Anxiety.

C. Decreased blood sodium.

D. Enlarged thyroid on physical examination.

E. B, C, and D only

F. All the above are adverse events (AEs).