PRACTICE QUIZ

Question 1

All IRB records need to be kept for ____ years follow completion of research

Accepted Answer

3

Question 2

the interest of science & society should never take precedence over considerations related to the well-being of the subj

Accepted Answer

Declaration of Helsinki

Question 3

A sponsor should submit to FDA a current list of names of investigators participating every ___ months

Accepted Answer

A.6

Question 4

Which of the following best describes the principle of informed consent as described in the Belmont Report?​

Accepted Answer

Comprehension, Information, Voluntariness

Question 5

Which is an example of how the Principle of Beneficence can be applied to a study employing human subjects?​

Accepted Answer

Determine that study has maximized benefit and minimized risk

Question 6

The responsibility for ensuring that the investigator understands a clinical trial lies with:

Accepted Answer

The Sponsor

Question 7

Number 19 of the practice exam

Accepted Answer

False

Question 8

How long do sponsors have to keep complete and accurate study records?

Accepted Answer

2

Question 9

Significant risk device is defined as an investigational device that is:

Accepted Answer

D

Question 10

IRB determinations for emergency situations are to be retained by IRB for at least ___ years after study ended

Accepted Answer

3

Question 11

Number 21 of the practice quiz

Accepted Answer

C

Question 12

The 3 fundamental ethical principles for human subjects in research are:

Accepted Answer

Respect for persons, beneficence, justice

Question 13

Which of the following is the proper way to make a correction to a CRF?

Accepted Answer

initials, add the date of the change, and, if necessary, an explanation

Question 14

IRBs must ensure special criteria are met b4 approve emergency research that allow subj entry w/o first obtaining ICF.​

Accepted Answer

True

Question 15

A sponsor shall notify all IRBs and investigators within ____ working days of there is withdrawal of FDA approval

Accepted Answer

5

Question 16

Subject must be reconsented when:

Accepted Answer

Changes in research that may affect subj's willingness to participate

Question 17

If investigator employs exception from gen req process 2 obtain consent, within _ days must a full report submit to IRB

Accepted Answer

5 working days

Question 18

Institution participate in research with other institutions may enter a joint review w another IRB, to comply w 21CFR56

Accepted Answer

True

Question 19

If no subject is enrolled within ___ years or if IND remains on hold for___ year, the IND can be out in inactive status

Accepted Answer

2 years, 1 years

Question 20

Serious/ unexpected ADRs that are not fatal or life threatening must be filed ASAP but no later than ____ calendar days

Accepted Answer

15

Question 21

True or False

Accepted Answer

True

Question 22

No more than _ days after imposing a hold on an IND will the division director provide sponsor a written explanation

Accepted Answer

30

Question 23

A sponsor shall within _____ days of anniversary date the IND went into effect provide a brief report

Accepted Answer

60

Question 24

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

Accepted Answer

3500

Question 25

A request to export an investigational drug from the U.S. must include:

Accepted Answer

A and C

Question 26

Which signatures are required by FDA regulation to be on a full consent form?​

Accepted Answer

The subject

Question 27

Form___________ is the investigator statement

Accepted Answer

1572

Question 28

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

Accepted Answer

3500A

Question 29

When a conflict arises between the ICF and the laws, the IRB approved and signed informed consent takes precedence.

Accepted Answer

False

Question 30

IRB must renew registration every ___ years (45CFR46.505)

Accepted Answer

3

Question 31

FDA will provide written determination within ____ days after FDA receives IND or IDE

Accepted Answer

30

Question 32

What is the minimum number of Institutional Review board (IRB) members?

Accepted Answer

5

Question 33

Which of these groups are considered vulnerable? ​

Accepted Answer

A and C only​

Question 34

Identify the manner in which the informed consent form (ICF) can be presented to the subject.

Accepted Answer

ICF can be read to the subject LAR

Question 35

A purpose of monitoring clinical trials is to verify that:

Accepted Answer

The rights, safety, and well-being of human subjects are protected

Question 36

Who monitors the progress of all clinical trial investigations being conducted under an IND?

Accepted Answer

Sponsor

Question 37

In a non-emergency situation, under which condition, may subjects be enrolled into a study prior to IRB/IEC approval?

Accepted Answer

Subjects cannot be enrolled until IRB/IEC approval has been obtained

Question 38

With respect to IRB/IEC membership, both the FDA and the ICH require that

Accepted Answer

At least one member's primary area of interest is in a nonscientific area

Question 39

True or False

Accepted Answer

False

Question 40

What is the definition of "legally authorized representative"?

Accepted Answer

s/o authorized under applicable law to consent on subj's behalf

Question 41

A subject has been enrolled on a study and was randomized to the non-treatment arm. Which of the following is correct?

Accepted Answer

B

Question 42

Within _____ months after termination or completion of trial, submit a final report to sponsor and IRB

Accepted Answer

3

Question 43

International ethical & scientific quality std 4 design/conduct/ record/reporting trials that involve human subj is

Accepted Answer

Good Clinical Practices (GCP)

Question 44

Choose the correct option:

Accepted Answer

B

Question 45

FDA has ____ days to respond to a sponsor request to lift an IND hold

Accepted Answer

30 calendar days after receipt

Question 46

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

Accepted Answer

The Declaration of Helsinki

Question 47

Sponsor needs to report IND safety reports to FDA and investigators within ____ calendar days

Accepted Answer

15

Question 48

Number 23 from practice quiz

Accepted Answer

A

Question 49

Ground for termination: IND remains inactive for ____ years

Accepted Answer

5+

Question 50

When a short form is used for Informed Consent, the witness must sign either the short form or the summary.

Accepted Answer

False

PRACTICE QUIZ

Questions 50

PRACTICE QUIZ

Questions 50