University of Cincinnati | Continuous Professional Development

Question 1

All Safety Letters (reports of external SAEs) received by a PI during a study should be forwarded to the site’s IRB.

A

True

B

False

Question 2

Central IRBs have all PIs in a multi-site study forward Sponsor safety letters to them, to assure the IRB that all PIs have received all of the letters the Sponsor sent out.

A

True

B

False

Question 3

Which is true about study events?

A

The occurrence of an adverse event means that use of the investigatinal product or study procedures/interventions must stop until the event has resolved or stabilized.

B

Documentation of unanticipated events is required and of anticipated events is optional.

C

If a participant calls the PI after the study is over and reports an adverse event that was considered anticipated, the event is to be reported to the IRB.

D

According to UC IRB definitions, a participant who is arrested and incarcerated (jailed) has experienced an event that must be reported to the IRB.

Question 4

Choose the best phrase to complete the sentence. If a participant reports at the study baseline visit having occasional muscle aches and the muscle aches continue during the study but do not get more frequent or worse, ___________ .

A

The site must continue to follow the participant and determine if an end date for the muscle aches occurs during the study, to complete the report of an AE.

B

Descriptions of the muscle aches are captured in the source records as medical history, and the participant is asked about them on an ongoing basis. There is no AE for the site to report unless the aches worsen (intensity or frequency).

C

The participant should be withdrawn from the study.

D

The site must follow the participant after the participant completes the protocol-required visits, until the muscle aches are fully resolved.

Question 5

Which if the following is false in regard to re-classification of adverse events?

A

Both downgrade (SAE to AE) and upgrade (AE to SAE) kinds of reclassifications are possible.

B

Numerous Sponsor re-classifications of AE to SAE reported from a particular Investigator site signals a need for additional training at that site.

C

Upgrading of an AE to an SAE must occur within the expedited reporting timeline expected for SAEs, for an upgrade to be properly done.

D

Discussion with a site’s monitor is usually not the correct way for a site to receive notice of event re-classification.

Question 6

Which one of the following study events does not qualify to be documented as an AE?

A

A participant developed sinus pressure after study Visit 2, he took no treatment for it, and it resolved before the date of Visit 3.

B

After Visit 2 a participant started taking a medication that he saw advertised on TV for “natural male enhancement” because he wanted to try it and see what enhancement meant for him.

C

A participant cut back on accustomed exercise a month after starting the study because of pain she developed in her feet.

D

A participant reports at Visit 3 that she feels sadder and more withdrawn than when she started on the study.

Question 7

Unanticipated problems that come to a site’s attention after the study has closed do not have to be reported to the IRB. Since the study is closed, IRB oversight has ceased.

A

True

B

False

Question 8

It is up to the study Sponsor whether both the initial and maximal intensity of each adverse event are to be separately assessed and documented.

A

True

B

False

Question 9

After initial approval of a study, an IRB can elect to stop the study if the adverse events that occur become too serious and/or too frequent.

A

True

B

False

Question 10

Choose the best phrase to complete the sentence. UC Policies concerning Adverse Events _____________ .

A

Are available only in person from the ORCRA offices in University Hall.

B

Are suggested guidelines for PIs to consider as they write their protocols and conduct their studies.

C

Are available to download or print from the UC web-site.

D

Are customizable by each Department of UC.

Question 11

Sponsors may define in the study protocol certain “ordinary” adbverse events that should receive expedited reporting to the Sponsor though the events do not meet any of the regulatory definitions of SAE.

A

True

B

False

Question 12

Choose the best phrase to complete the sentence. Assessment of AE intensity and AE relatedness to the study drug/device or interventions ________ .

A

Can be done by anyone on the study team who has contact with the participant.

B

Must be done by the PI only, for continuity.

C

Should be done by a medically qualified person who is listed on the delegation of duties log as able to perform AE assessment.

D

Should be done by the Sponsor’s Medical Monitor.

Question 13

An adverse event of nasal congestion with an intensity judged to be severe should always be classified an SAE instead of an “ordinary” AE.

A

True

B

False

Question 14

Unanticipated AEs that are not SAEs should be reported to the IRB, at least annually as part of the continuing review progress report.

A

True

B

False

Assessment for FDA - Adverse and Other Events in Human Research