Session 5 (pop quizzes)

Question 1

What year was the Nuremburg Code published?

Answer 1

1947

Question 2

What event led to the National Research Act?

Answer 2

Tuskegee Syphilis Study

Question 3

What was developed by the WMA in 1964?

Answer 3

Declaration of Helsinki

Question 4

What are the three basic ethical principles?

Answer 4

Respect, Beneficence, Justice

Question 5

Class I devices are classified as:

Answer 5

Little risk/not invasive

Question 6

If an investigator uses a device without obtaining informed consent, the investigator must notify the sponsor and reviewing IRB within how many days?

Answer 6

5 working days

Question 7

How often must an IRB renew their registration?

Answer 7

every 3 years

Question 8

Prior to filing a marketing application, how often should the Sponsor submit progress reports for devices to ALL IRBs and the FDA?

Answer 8

semi-annually

Question 9

How often should the investigator submit progress reports for devices to the IRB and the sponsor?

Answer 9

annually

Question 10

An investigator/sponsor may use an investigational drug for emergency use for the treatment of an individual patient if:

Answer 10

a) The patient to be treated has a serious or immediately life-threatening disease or condition, and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition
b) The potential patient benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease or condition to be treated
c) Use of the drug will not interfere with ongoing clinical investigations with the drug for marketing approval

Question 11

If there is an emergency that requires the patient to be treated before a written submission can be made to the FDA, individual investigator/sponsor must submit an expanded access use application within how many days?

Answer 11

15 working days

Question 12

A sponsor or applicant must retain the records for a foreign clinical study not conducted under an IND if the study is submitted in support of an IND but not an application for marketing approval for how many years?

Answer 12

2 years

Question 13

The sponsor must also notify FDA of any unexpected fatal or life-threatening suspected adverse reaction as soon as possible but in no case later than how many days after the sponsor’s initial receipt of the information?

Answer 13

7 days

Question 14

The IB or Investigator’s Brochure IS NOT REQUIRED to contain which section?

Answer 14

confidentiality statement

Question 15

How often should the IB be reviewed and revised as appropriate?

Answer 15

annually

Question 16

Who MUST maintain the certificate of analysis of the investigational product shipped?

Answer 16

the sponsor

Question 17

Who MUST maintain copies of the signature/ enrollment log?

Answer 17

the investigator

Question 18

Where MUST the trial master files be kept?

Answer 18

with the sponsor and the investigator

Question 19

Form ____ is the investigator statement

Answer 19

1572

Question 20

What is 45 CFR Part 46?

Answer 20

HHS - Protection of Human Subjects

Question 21

The Code of Federal Regulations that applies to Investigational New Drug Applications is 21 CFR 812. TRUE OR FALSE

Answer 21

false

Question 22

The World Medical Association (WMA) ethical principles for medical research involving human subjects is called:

Answer 22

The Declaration of Helsinki

Question 23

The international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects is known as:

Answer 23

Good Clinical Practices (GCP)

Question 24

The Code of Federal Regulations that applies to Institutional Review Boards is:

Answer 24

21 CFR 56

Question 25

This form is used for the voluntary reporting of adverse events and product problems:

Answer 25

3500

Question 26

This form is used for the mandatory reporting of serious adverse events:

Answer 26

3500A

Question 27

The clinical investigator will update the financial disclosure information if any relevant changes occur during the investigation's course and for _______ following the study's completion.

Answer 27

1 year

Question 28

When using the short form informed consent, the witness and the person actually obtaining the consent from the subject shall each sign the short form in addition to the summary. TRUE OR FALSE

Answer 28

false The witness shall sign BOTH the short form and summary. Person actually obtaining consent shall sign ONLY a copy of the summary. (Subject ONLY has to sign the short form).

Question 29

Per 21 CFR Part 312, the sponsor must notify FDA and all participating investigators in an IND safety report within 15 calendar days after the sponsor determines that the information qualifies for reporting.

Answer 29

true

Question 30

Proper preparations should be made and adequate facilities provided to protect the experimental subject against even the remotest possibility of:

Answer 30

Injury, disability or death

Question 31

A request to export an investigational drug from the U.S. must include A. The quantity of drug to be shipped per shipment and the frequency of expected shipments. B. Adequate information about the drug to satisfy the FDA that the drug is appropriate for the proposed investigational use in animals. C. A statement that the drug will be used for investigational purposes only and that the drug may be legally used by that consignee in the importing country for the proposed use. D. All of the above E. A & C only

Answer 31

E: A & C only

Question 32

An investigational drug can be exported from the U.S., if:

Answer 32

Approval is granted after a written request is submitted to the FDAs International Affairs Staff Associate Commissioner.