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

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

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

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

An investigator received an updated investigator's brochure from the sponsor; the update did not include changes related to subject safety. Which of the following parties, if any, is the investigator required to noti

Options :

A : The IRB/IEC

B : The Data Safety Monitoring Board (DSMB)

C : The regulatory authority

D : No notification is required

Answer: D