SAMPLE TEST QUESTIONS

Each test will consist of 15 randomly accessed questions.

1. Select the governmental agency responsible for monitoring clinical research in the U.S. (select one):

1. DHHS
2. OHRP
3. FDA
4. ICH

2. IND application is submitted to FDA before Phase _______of a clinical trial (fill-in the blank):

1. Phase I
2. Phase II
3. Phase III
4. Phase IV

3. The clinical Investigator is responsible for (select one):

1. Training of all staff members
2. Administration of Informed Consent to patients
3. Reporting SAE to IRB and FDA
4. Drug Accountability
5. All of the above
6. None of the above

4. The following document is prepared before patient enrollment (select one):

1. Source documents
2. Informed Consent
3. Case Report Form
4. Regulatory Binder

5. Informed Consent is developed mainly to protect the safety of the volunteer subject.

1. True
2. False

6. IRB is responsible for the following except (select one):

1. Ensuring prompt reporting to institutional and regulatory agencies
2. Review and approval of changes in research activities
3. Translating consent forms for non-English speaking subjects
4. Determining which study device poses significant or non-significant risk

7. Which of the following is true in regards to the consent process (select one)?

1. FDA requires the investigator to personally obtain the consent
2. A signed copy of the consent must be provided to the subjects
3. The Investigator must ensure that each patient is consented prior to enrollment
4. When Investigator delegates the consent authority, he/she is not responsible for the consent process

8. FDA has the following authority to review a NDA (select as many as possible):

1. To issue an approval letter or a non-approval letter to the agency
2. At least for 360 days
3. To require investigators to submit data to include the NDA
4. None of the above

9. What information must be contained in the FDA Form 1572?

1. Investigator commitment to conduct study according to FDA requirements
2. The name and address of the Investigator institution
3. The names of sub-investigators in the study
4. All of the above

10. The following must be submitted by the investigator to the FDA

1. Progress Reports
2. Case Report Forms
3. Final reports
4. None of the above

11. To qualify for a clinical study, a sponsor must evaluate which of the following criteria are true?

1. Personnel
2. Facilities
3. Equipment
4. Infra-structure
5. All of the above

12. A query is generated by sponsor so that the investigator can (select as many):

1. Double-check the discrepancy and provide correct information
2. Delegate more work
Submit after the close out
3. None of the above

13. When a subject completes or early terminated from a study, the investigator should:

1. Perform the required assessment for the termination visit
2. Follow the subject appropriately until SAE issues are resolved
3. Provide sponsor and IRB with periodic updates and final SAE report
4. All of the above

14. When a study ends, one of the responsibilities of the investigator is to:

1. Submit a final report to IRB
2. Request an FDA audit to ensure data accuracy
3. Present the study data at a medical conference
4. Keep the most recent regulatory documents and shred the rest

15. When an investigator intends the study documents to another location, the investigator should:

1. Scan all documents without sponsor authorization
2. Keep the facility name and location secret for confidentiality
3. Hire some one to move and bill the sponsor
4. None of the above