Definitions

Question 1

Permission to examine, analyze, verify, & reproduce any records and reports important to a trial

Answer 1

direct access

Question 2

comparator

Answer 2

product or placebo used in an investigation

Question 3

LAR

Answer 3

legally authorized representative (for a patient)

Question 4

What is a short form

Answer 4

document that states the elements of the informed consent have been presented orally to and understood by participant or LAR

Question 5

short form consent, oral presentation, and summary are examples of what?

Answer 5

components

Question 6

when are components used?

Answer 6

-when a non-English translated IC is not available
-when window of treatment is short

Question 7

Data & safety monitoring plan

Answer 7

a plan that is used to ensure the safety of subjects

Question 8

A group of experts that review research data to ensure subject safety & data validity

Answer 8

Data safety monitoring committee

Question 9

What is blinding?

Answer 9

Method where personnel involved in a trial are intentionally prevented from knowing the treatment arms/treatment assignment to patients

Question 10

Which blinding type: sponsor, PI/staff & patients are blinded

Answer 10

triple blind

Question 11

How many types of blinding are there?

Answer 11

4 types
- triple
-double
-single
-open label (none)

Question 12

single blinding

Answer 12

when only the subjects are blinded

Question 13

double blinding

Answer 13

PI/staff & subjects are blinded

Question 14

NIDPOE

Answer 14

Notice of initiation of disqualification proceedings & opportunity to explain

Question 15

When is a NIDPOE issued by the FDA?

Answer 15

When an investigator may be disqualified due to non-compliance

Question 16

randomization

Answer 16

method where subjects are randomly assigned into different treatment arms.

Question 17

cirriculum vitae

Answer 17

Qualifications of the investigator showing education, training, & experience that qualifies them as an expert

Question 18

CAPA

Answer 18

Corrective & preventative actions

Question 19

What is CAPA

Answer 19

Process to identify root cause of issues or problems & actions to resolve them

Question 20

ICH

Answer 20

International Council for Harmonization

Question 21

HHS

Answer 21

Department of Health and Human Services

Question 22

The World Medical Association is involved with which foundation?

Answer 22

The Declaration of Helsinki

Question 23

3 principles of the Belmont Report

Answer 23

1. Respect of persons
2. Beneficence
3. Justice

Question 24

The 2 expressions of beneficent actions in terms of human trials/ethical principles

Answer 24

1. Do not harm
2. Maximize possible benefits and minimize possible harms

Question 25

Biochemical & physiological effects of a drug

Answer 25

Pharmacodynamic

Question 26

Activity of a drug in the body over time

Answer 26

Pharmacokinetic

Question 27

Stratification is ___ and an example is ___

Answer 27

Arrangement of classification of something into different groups.
Randomizing men and women separately because a drug may metabolize differently for each gender

Question 28

Significant risk device

Answer 28

Investigational device that presents a potential for serious risk to the health, safety, or welfare of a subject

Question 29

A device that does not meet the definition of a significant risk device

Answer 29

Non-significant risk device

Question 30

Measures believed to quantify the potential effect of a treatment or therapy

Answer 30

Endpoints

Question 31

Audit’s major purpose

Answer 31

To confirm site is confirming SOPs are being upheld

Question 32

To oversee sponsor, monitor, investigator & IRB to determine whether all groups meet regulatory responsibilities

Answer 32

Inspection

Question 33

To ensure that study & procedures are properly documented & verify the integrity of data

Answer 33

To audit

Question 34

What is indemnification?

Answer 34

The definition of duties and responsibilities of the involved parties in cases of loss or injury linked to a clinical trial