Question 1

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 2

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 3

In order to adequately monitor a clinical trial, the monitor must be familiar with each of the following, EXCEPT the:

Options :

A : Written information to be provided to the subjects

B : Requirements for storage of the investigational product

C : Sponsor's SOPs

D : IRB/IEC requirements for reporting to the regulatory authority

Answer: D

Question 4

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 5

A sponsor is permitted to charge for an investigational drug but must provide what documentation?

Options :

A : CMS approval letter

B : Orphan product evidence

C : IRB attestation of institutional cost burden

D : Evidence of potential clinical benefit and significant advantage

Answer: D

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