The Research Protocol
1. Which of the following refers to a document containing nonclinical and clinical data that describe the previous experience with the experimental intervention, often a medication?
A. The Research Protocol
B. The Operations Manual
C. The Investigator's Brochure
D. The IRB Membership Roster
2. 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
3. Which of the following would NOT be a good example of a protocol violation?
A. The Research Coordinator has consistently arrived late to study visits.
B. Only participants over 30 years old have been given the study remuneration described in the protocol.
C. Two participants were enrolled in the study although they do not meet the inclusion criteria.
D. A CBC blood specimen is collected before the participant has signed an Informed Consent form.
4. A protocol violation is:
A. An omission (i.e., failure to do something required in the protocol)
B. An addition (i.e., any action that is not required in the protocol).
C. A change in any procedure described in the protocol
D. All of the above.
5. 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.