Vous êtes sur la page 1sur 6

Quiz: Quality Assurance

Common problems identified in audits by the U.S. Food and Drug


Administration (FDA) include which of the following:

A. Inadequate oversight at the Clinical Coordinating Center.

B. Inadequate records that do not support the reported data.

C. Inadequate study drug accountability.

D. A and B

E. B and C

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
When research sites collect incorrect data or do not maintain good
documentation practices, what can be a consequence?

A. Sloppy or incorrect data can lead to misleading conclusions.

B. Study investigators will increase credibility when publishing results.

C. Results of studies are interpreted correctly.

D. All of the above.

Protocol Monitors perform which of the following duties during the conduct of
a trial:

A. Verify the accuracy of reported trial data.

B. Verify the financial statements of the research site.

C. Verify that the site has the adequate resources to continue the trial.

D. Verify that all research site staff has documentation of driver's licensure.

E. Verify that participant rights and well-being is being protected.

F. A, C, and E

G. B, D, and E
Based on Good Clinical Practice (GCP) guidelines, the research site
investigator has the primary responsibility for selecting study monitors.

A. TRUE

B. FALSE

Quality Assurance in clinical trials consists of planned, systematic activities that are conducted to
ensure that study data are generated, documented, and reported in compliance with:
A. The research protocol.

B. Good Clinical Practice (GCPs) guidelines.

C. FDA regulations.

D. All of the above.

Quality Assurance is the responsibility of all research team members.

A. TRUE

B. FALSE

Common problems identified in audits by the U.S. Food and Drug Administration (FDA) include
which of the following:

A. Inadequate oversight at the Clinical Coordinating Center.

B. Inadequate records that do not support the reported data.


C. Inadequate study drug accountability.

D. A and B

E. B and C

The sponsor has the ultimate responsibility for implementing and maintaining Quality Assurance
systems.

A. TRUE

B. FALSE

On-site monitoring activities are conducted:

A. At study initiation.

B. At study closeout.

C. Before, during, and after completion of the study.

D. On an "as needed" basis.

The role of monitoring is to support and assist members of the study team to
maintain high quality standards.

A. TRUE
B. FALSE

The sponsor has the ultimate responsibility for implementing and maintaining
Quality Assurance systems.

A. TRUE

B. FALSE

Common problems identified in audits by the U.S. Food and Drug


Administration (FDA) include which of the following:

A. Inadequate oversight at the Clinical Coordinating Center.

B. Inadequate records that do not support the reported data.

C. Inadequate study drug accountability.

D. A and B

E. B and C

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

Site 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.