Question 1

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 2

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 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

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

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

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