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The Clinical Researcher Knowledge Testing
Answer the questions below and then click the button. The next page will mark your answers and show you how well you have done compared with the previous people who have taken the tests.

Test Title:
Adverse Events


Question Number 1:
What is the timeline for the sponsor to report a SUSAR which prolongs hospitalisation?
A
 Immediately
B
 7 days
C
 15 days
D
 In the annual safety report

Question Number 2:
What is the definition of "unexpected" in terms of ADRs
A
 It's never been seen before
B
 The study staff weren't expecting it in that particular patient
C
 The patient wasn't expecting it
D
 It has not been reported in any literature

Question Number 3:
Which of the following does not appear in the definition of an SAE?
A
 Prolongs hospitalisation
B
 Life-threatening
C
 Cancer
D
 Congenital anomaly

Question Number 4:
What is the difference between an SAE and a SUSAR?
A
 A SUSAR is an SAE which is unexpected and considered to be related to the study drug
B
 An SAE is not related to the study drug and a SUSAR is
C
 A SUSAR is not reported as quickly as an SAE
D
 There is no difference

Question Number 5:
The _________ is responsible for the ongoing safety evaluation of the investigational product
A
 investigator
B
 IEC/IRB
C
 regulatory authority
D
 sponsor

Question Number 6:
Which category of Adverse Event does this fall into: A patient suffers a minor stroke but does not go to hospital. However mobility is permanently affectedso that the patient cannot walk properly. The investigator does not think this is drug related.
A
 Just an Adverse Event
B
 Serious Adverse Event
C
 SSAR
D
 SUSAR

Question Number 7:
Which category of Adverse Event does this fall into: A patient is hospitalised with stomach pain from an undiagnosed cause which resolves within 24 hours. This has been reported before with this product.
A
 Just an Adverse Event
B
 Serious Adverse Event
C
 SSAR
D
 SUSAR

Question Number 8:
Of what is this part of the ICH GCP definition: "all noxious and unintended responses to a medicinal product related to any dose"?
A
 Adverse Event
B
 Adverse Drug Reaction
C
 Investigators Brochure
D
 Protocol

Question Number 9:
According to ICH what is the definition of "life-threatening" in classifying adverse events?
A
 A condition which could cause death immediately or if it continued to progress.
B
 An event where the subject needed resuscitation.
C
 An event which caused the subject to believe they were going to die.
D
 An event in which the patient was at risk of death at the time of the event; but not one which could have caused death if it had become more severe.

Question Number 10:
Which adverse events are subject to expedited reporting?
A
 All adverse events
B
 Fatal and Lifethreatening SUSARs only
C
 All SUSARs
D
 All SSARs

 

 

 

 

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