Free CCRC Detailed Role Questions and Answers

Question 1

Which of the following scenarios are considered SAEs?

Accepted Answer

infection following surgery prolonging hospital stay

Answer

pregnancy resulting in normal delivery of twins

Answer

use of illicit drug during the trial

Question 2

Which of the following are responsibilities of an IDMC/DSMB

Accepted Answer

assess the progress of a trial

Answer

assess the financial aspects of a trial

Answer

recommend initiating a trial

Question 3

The trough blood level for a once-daily drug should be drawn how long after the dose?

Accepted Answer

24 hours

Answer

20 hours

Answer

48 hours

Answer

15 hours

Question 4

A CRA calls a CRC to schedule the final monitoring visit. The sponsor requires that the PI be present. The only dates available for the CRA conflict with the PI's schedule. To prepare for the visit, the CRC should:

Accepted Answer

reschedule the visit

Answer

have the PI sign all documents prior to the visit

Answer

discard unused trial documents.

Answer

notify the IRB/IRC

Question 5

A CRA is conducting a close-out visit at a site to review the regulatory documents. The CRC has prepared the following documents to be filed and/or sent to the sponsor: treatment decoding documentation code list, documentation of IP destruction and final report to the IRB/IEC. Which of the following actions should the CRC perform?

Accepted Answer

Send the treatment decoding documentation to the sponsor

Answer

Remove the drug accountability log from the material to be sent to the sponsor

Question 6

A CRC is screening subjects for an oral IP. All subjects must be stabilized on currently approved medications. Which of the following questions should be asked by the CRC?

Accepted Answer

When was the last time your medication dose changed?

Answer

Have you made any dietary changes in the last month?

Answer

When was your last chest x-ray and ECG?

Question 7

A PI has an enrollment goal of 24 subjects. Ten potential subjects are seen each week. Twenty percent of the potential subjects will not be interested in participating. Fifty percent of the subjects who are interested will fail to meet one or more inclusion/exclusion criteria. How long will it take the CRC to fulfill enrollment?

Accepted Answer

6 weeks

Answer

5 weeks

Answer

7 weeks

Answer

8 weeks