Question 1

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 2

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 3

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 4

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

Question 5

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