Minnesota State University, Mankato

ETHN 101

Quiz 2 Roles and Responsibilities

1)Which of the following entities must review and approve human clinical research trials before the research can begin?

1. 1. DEA
   2. FDA
   3. HHS
   4. IRB

2. Who is responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, and ensuring proper monitoring of the investigation?
   1. FDA
   2. IRB
   3. Sponsor
   4. None of the above

3. According to U.S. federal regulations, which of the following individuals is responsible for the conduct of clinical research at an investigational site?
   1. Clinical Research Associate
   2. IRB Chairperson
   3. Medical Monitor
   4. Principal Investigator

4. The Principal Investigator is responsible for ensuring that the investigation is conducted according to which of the following?

1. 1. Applicable regulations
   2. Investigational Plan (study protocol)
   3. Signed Investigator Agreement
   4. All of the above

5. Which of the following is the governing federal regulatory authority for clinical research activities for market authorization in the U.S.?
   1. Department of Health and Human Services (HHS)
   2. Food and Drug Administration (FDA)
   3. Institutional Review Board (IRB)
   4. Office of Human Subject Research (OHSR)

6. At a minimum, how long must an investigator maintain all records and reports associated with a clinical research trial?
   1. 2 years after the last action of the marketing application
   2. 2 years after the end of the clinical research trial
   3. 3 years after the end of the study
   4. Until the FDA notifies the sponsor

7. You are a clinical research coordinator at a research site conducting a trial to test an experimental drug to treat cancer that has not been previously approved for marketing. During a meeting, the Principal Investigator asks you to find more detailed information regarding the safety data previously collected for this investigational drug. Who should you contact to find out this information?
   1. CDER (Center of Drug Evaluation and Research)
   2. FDA
   3. IRB
   4. Sponsor

8. Which of the following are international guidelines for the conduct of human clinical research drug studies?
   1. ICH E6
   2. ICH M2
   3. ISO 14155
   4. ISO E6