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

A subject has creatinine 1.6 mg/dL, slightly above eligibility (â‰¤1.5). Investigator believes this is normal for size. When can subject be enrolled?

Options :

A : After sponsor revises eligibility and IRB approves amendment

B : After repeat test confirms 1.6

C : After monitor approves deviation

D : After investigator documents explanation in chart

Answer: A

Question 3

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

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

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

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