1 Which section of the research protocol should contain the reason...

1 Which section of the research protocol should contain the reason for the choice of sample size?

A. Statistics

B. Quality Control and Quality Assurance

C. Data Management

D. Study Objectives and Purposes

2 Which of the following would you NOT expect to find in the Study Design section of the research protocol?A. A description of primary and secondary endpoints.

B. A schematic diagram of the study design.

C. The methods for recording and analyzing the effectiveness criteria.

D. The expected duration of participant participation.

3 Which of the following would you NOT expect to find in the Treatment of Subjects section of the research protocol?

A. The names of all medications to be administered.

B. The dosing schedules of all medications to be administered.

C. Procedures for assessing treatment adherence.

D. Procedures for accounting for missing, unused, and false data.

4 Unless there is an immediate safety concern, implementation of an amendment to a protocol (that does not involve a product regulated by the FDA) must be approved by:

A. Food and Drug Administration (FDA).

B. Institutional Review Board (IRB).

C. Sponsor.

D. All of the above.

5 Which section of the research protocol should describe the pharmacological treatment and any other interventions included in the study?

A. Treatment of Subjects

B. Data Management

C. Selection and Withdrawal of Participants

D. Assessment of Safety