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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: Pharmacovigilance in clinical trials

Question Number 1:
Which ICH Guideline provides definitions and standards for expedited reporting of adverse events?
A
 E2A
B
 E2B
C
 E2C
D
 E2D

Question Number 2:
According to ICH all noxious and unintended responses to a medicinal product related to any dose should be considered what?
A
 Adverse Events
B
 Adverse Drug Reactions
C
 Serious Adverse Events
D
 SUSARs

Question Number 3:
According to ICH for which Serious Adverse Events is expedited reporting normally inappropriate?
A
 Unexpected and not related
B
 Expected and not related
C
 Expected and related
D
 All of the above

Question Number 4:
According to ICH which of the following observations require expedited reporting to Regulatory Authorities?
A
 An increased rate of occurrence of an "expected"serious ADR
B
 A significant hazard to the patient population such as lack of efficacy
C
 A major safety finding from a newly completed animal study
D
 All of the above

Question Number 5:
According to ICH guidance which of the following is most true regarding expedited reporting of reactions to active comparator products?
A
 The sponsor must report them to the regulatory authority
B
 The sponsor can decide whether to report them to the product's manufacturer or the regulatory authority
C
 The sponsor must report them only to the manufacturer
D
 They do not need to be reported

 
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