Question 1

A clinical investigator terminated a Phase IV drug study. In accordance with the ICH GCP Guidelines, which of the following documents should the clinical investigator maintain?

Options :

A : The master randomization list

B : The completed subject identification code list

C : The final trial closeout monitoring report

D : The audit certificate

Answer: B

Question 2

In accordance with ICH, which of the following is an acceptable protocol review frequency for an IRB?

Options :

A : 6 months

B : 12 months

C : 24 months

D : 36 months

Answer: B

Question 3

In accordance with the CFR, for at least how many years after the completion of a study must the clinical investigator provide the sponsor with relevant changes to financial information?

Options :

A : One year

B : Two years

C : Three years

D : Five years

Answer: B

Question 4

Which of the following should a clinical investigator include in a submission to an IRB/IEC for a Phase IV drug study?

Options :

A : The itemized study budget

B : The amount of payments and compensation to subjects

C : The drug development and marketing plan

D : The investigator's clinical trial agreement with the sponsor

Answer: B

Question 5

For an investigational new drug study that has potential side effects of myalgia, arthralgia, and lethargy, which of the following could serve as an acceptable consent statement?

Options :

A : You might experience adverse events of myalgia, arthralgia, and lethargy

B : You might have some muscle aches, joint pain, and tiredness

C : You might develop symptoms of myalgia, arthralgia, and tiredness

D : You might have some mild side effects while taking the investigational drug

Answer: B

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