Question 1

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 2

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 3

Upon completion of a study, the investigator should do which of the following?

Options :

A : As soon as possible, provide the IRB/IEC with a final report that summarizes the trial's outcome

B : Ensure that all payments from sponsor have been received

C : Provide the IRB/IEC a final report, but only if the study has a positive outcome

D : Compile site data, publish the study results, and submit the publication to the IRB/IEC as the final report

Answer: A

Question 4

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 5

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