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Quality Assurance 1Protocol Monitor responsibilities are outlined...

Quality Assurance


1Protocol Monitor responsibilities are outlined in GCP guidelines, and include which one of the following responsibilities?

A. Verifying investigator and research staff qualifications.

B. Consenting research participants.

C. Performing physical examinations.

D. Administering investigational drug to research participants.

2Based on Good Clinical Practice (GCP) guidelines, the Sponsor has the primary responsibility for selecting study monitors.

A. TRUE

B. FALSE

3Site staff may begin recruitment upon completion of all action items required for endorsement, when adequate staff is available and fully trained in their study roles, and after ____.

A. The research site investigator sends a letter to the sponsor advising of their site-appointed start date.

B. The research site has been inspected and received approval from an FDA Inspector.

C. The Lead Investigator and sponsor have provided their approval.

D. None of the above.

4Quality data are critical to ensure that the study results are ________.

A. Stored in the documentation of research sites during the conduct of a study.

B. Available for participants to review easily when a study is blinded.

C. Interpreted correctly.

D. None of the above.

5Once a research site has completed enrollment, protocol monitors do not conduct any additional site visits.

A. TRUE

B. FALSE

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