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

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 3

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 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 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