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

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

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 4

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 5

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

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