Free CCRC Detailed Role Questions and Answers

Which of the following scenarios are considered SAEs?

Please select 2 correct answers

infection following surgery prolonging hospital stay

pregnancy resulting in normal delivery of twins

boating accident with overnight hospitalization

use of illicit drug during the trial

Correct! Wrong!

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?

6 weeks

5 weeks

7 weeks

8 weeks

Correct! Wrong!

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:

reschedule the visit

have the PI sign all documents prior to the visit

discard unused trial documents.

notify the IRB/IRC

Correct! Wrong!

Which of the following are responsibilities of an IDMC/DSMB

Please select 2 correct answers

assess the financial aspects of a trial

assess the progress of a trial

recommend initiating a trial

recommend stopping a trial

Correct! Wrong!

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?

Please select 2 correct answers

When was the last time your medication dose changed?

Have you made any dietary changes in the last month?

When was your last chest x-ray and ECG?

Do you have any difficulty swallowing oral medications?

Correct! Wrong!

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

24 hours

20 hours

48 hours

15 hours

Correct! Wrong!

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?

Please select 3 correct answers

Send the treatment decoding documentation to the sponsor

Remove the subject identification code list from the material to be sent to the sponsor.

Send copies of the IP destruction forms to the sponsor.

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

Correct! Wrong!

Free CCRC Detailed Role Questions and Answers

Which of the following scenarios are considered SAEs?

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:

Which of the following are responsibilities of an IDMC/DSMB

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?

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

Free CCRC Career Prospects Questions and Answers

Free CCRC Responsibilities Questions and Answers

CCRC Test: Your Path to Clinical Research Success

Which of the following scenarios are considered SAEs?

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:

Which of the following are responsibilities of an IDMC/DSMB

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?

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

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