Question 1

A subject has creatinine 1.6 mg/dL, slightly above eligibility (â‰¤1.5). Investigator believes this is normal for size. When can subject be enrolled?

Options :

A : After sponsor revises eligibility and IRB approves amendment

B : After repeat test confirms 1.6

C : After monitor approves deviation

D : After investigator documents explanation in chart

Answer: A

Question 2

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

Question 3

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 4

According to the ICH GCP Guidelines, what is the purpose of source documents?

Options :

A : To establish diverse subject enrollment

B : To validate insurance reimbursement

C : To provide a record of subjects investigational medical treatment

D : To validate reports submitted to the IRB/IEC

Answer: C

Question 5

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

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