Quiz: Quality Assurance

1

Quality 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.

2

Who is expected to ensure the highest possible standards of quality are maintained in the conduct of a trial?

A. Study Investigators.

B. Research Staff.

C. Study Monitors.

D. The Sponsor.

E. All members of the study team.

3

Study monitors are ________.

A. Familiar with the product under investigation in the study.

B. Appropriately trained and have qualifications to monitor clinical studies.

C. Not required to have any specific knowledge of the trial or the investigational product.

D. All of the above.

E. A and B

4

Protocol 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.

5

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

A. TRUE

B. FALSE