Question 1

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 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

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 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