Practice Questions

Question 1

Which patient population best aligns with crossover study design?

Answer 1

• patients with chronic conditions
• may be infeasible or unethical for curative treatments or rapidly changing conditions

Question 2

Effect size

Answer 2

Quantitative measure of the magnitude of a phenomenon (correlation between variables)

Question 3

Why is the influence of confounders reduced in crossover studies?

Answer 3

Each patient is their own control

Question 4

Variable that influences both dependent and independent variables

Answer 4

Confounders

Question 5

Inch to centimeter

Answer 5

x 2.54

Question 6

Acute bacterial infection is suggested by

Answer 6

High neutrophil levels

Question 7

Acute hepatitis is suggested by-

Answer 7

High SGOT and ALT

Question 8

Liver function tests

Answer 8

AST, ALT, ALK Phos and HCT

Question 9

*F to *C

Answer 9

-32 x 5/9

Question 10

*C to *F

Answer 10

x 1.8+32

Question 11

What is the purpose of ICH-GCP?

Answer 11

Standardize the design, conduct, recording and reporting of clinical trials

Question 12

What is the purpose of the IRB/IEC?

Answer 12

Protect subject safety

Question 13

Who is responsible for providing the trial protocol?

Answer 13

Sponsor

Question 14

According to ICH, “LAR” stands for Legally Authorized Representative

Answer 14

False- Legally Acceptable Representative

Question 15

What does DSMB stand for?

Answer 15

Data Safety and Monitoring Board

Question 16

World Medical Association’s (WMA) ethical principles for medical research involving human subjects is called-

Answer 16

Declaration of Helsinki

Question 17

The process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial-

Answer 17

Informed consent of trial subjects

Question 18

One primary purpose of a Phase 1 study-

Answer 18

Determine the metabolic and pharmacologic action of the drug in humans

Question 19

Purpose of the Data Safety Monitoring Board

Answer 19

Assess the progress of a clinical trial, the safety data and critical efficacy endpoints

Question 20

Purpose of the initiation visit

Answer 20

• Review the protocol
• Review standard procedures
• Review blank Case Report Forms (CRFs)

Question 21

Who is ultimately responsible for source data verification (SDV)?

Answer 21

Monitor

Question 22

Every research study involving human subjects must be registered in a publicaly accessible database before recruitment of the first subject

Answer 22

True

Question 23

Declaration of Helsinki was developed by-

Answer 23

World Medical Association

Question 24

Which groups can be members of an IRB/IEC?

Answer 24

• Lay people
• Medical professionals

Question 25

What format should approval be received from the IRB/IEC?

Answer 25

Written

Question 26

How to best define Adverse Drug Reaction (ADR)?

Answer 26

A noxious and unintended response to the investigational drug

Question 27

Which would be most appropriate for adverse event (AE) reporting?

Answer 27

Documenting and reporting all AEs no matter how trivial they appear

Question 28

Which criteria is described by ICH-GCP as necessary for classifying an AE as an adverse drug reaction?

Answer 28

Causal relationship is at least a reasonable possibility

Question 29

What information needs to be included in the subject's medical records?

Answer 29

- Occurrence of any AEs - Medical history - Randomization number

Question 30

Who conducts clinical research Quality Control activities?

Answer 30

Monitor

Question 31

According to the Declaration of Helsinki, physicians may use an unproven intervention?

Answer 31

True

Question 32

Minimum amount of time after formal discontinuation of clinical development of an investigational product that essential documents should be retained?

Answer 32

2 years after last marketing application approval in an ICH-GCP region

Question 33

Medical research with a vulnerable group is only justified if the research is responsive to health needs or priorities of this group and cannot be carried out in a non-vulnerable group. This groups should stand to benefit from the knowledge, practices or interventions that result from the research.

Answer 33

True