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

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 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

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 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

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