Question 1

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 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

Which of the following is one of the responsibilities of an investigator who is NOT a sponsor?

Options :

A : Reporting serious adverse events to the applicable regulatory agency

B : Ensuring proper monitoring of an investigation at all investigational sites

C : Ensuring that all participating investigators are promptly informed of significant new adverse events

D : Maintaining control of the investigational product

Answer: D

Question 4

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 5

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