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CCRC Exam Prep > Practice Questions > Flashcards

Practice Questions Flashcards

1
Q

Which patient population best aligns with crossover study design?

A
  • patients with chronic conditions
  • may be infeasible or unethical for curative treatments or rapidly changing conditions
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2
Q

Effect size

A

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

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3
Q

Why is the influence of confounders reduced in crossover studies?

A

Each patient is their own control

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4
Q

Variable that influences both dependent and independent variables

A

Confounders

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5
Q

Inch to centimeter

A

x 2.54

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6
Q

Acute bacterial infection is suggested by

A

High neutrophil levels

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7
Q

Acute hepatitis is suggested by-

A

High SGOT and ALT

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8
Q

Liver function tests

A

AST, ALT, ALK Phos and HCT

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9
Q

*F to *C

A

-32 x 5/9

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10
Q

*C to *F

A

x 1.8+32

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11
Q

What is the purpose of ICH-GCP?

A

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

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12
Q

What is the purpose of the IRB/IEC?

A

Protect subject safety

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13
Q

Who is responsible for providing the trial protocol?

A

Sponsor

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14
Q

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

A

False- Legally Acceptable Representative

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15
Q

What does DSMB stand for?

A

Data Safety and Monitoring Board

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16
Q

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

A

Declaration of Helsinki

17
Q

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

A

Informed consent of trial subjects

18
Q

One primary purpose of a Phase 1 study-

A

Determine the metabolic and pharmacologic action of the drug in humans

19
Q

Purpose of the Data Safety Monitoring Board

A

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

20
Q

Purpose of the initiation visit

A
  • Review the protocol
  • Review standard procedures
  • Review blank Case Report Forms (CRFs)
21
Q

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

A

Monitor

22
Q

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

A

True

23
Q

Declaration of Helsinki was developed by-

A

World Medical Association

24
Q

Which groups can be members of an IRB/IEC?

A
  • Lay people
  • Medical professionals
25
Q

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

A

Written

26
Q

How to best define Adverse Drug Reaction (ADR)?

A

A noxious and unintended response to the investigational drug

27
Q

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

A

Documenting and reporting all AEs no matter how trivial they appear

28
Q

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

A

Causal relationship is at least a reasonable possibility

29
Q

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

A
  • Occurrence of any AEs
  • Medical history
  • Randomization number
30
Q

Who conducts clinical research Quality Control activities?

A

Monitor

31
Q

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

A

True

32
Q

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

A

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

33
Q

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.

A

True

CCRC Exam Prep (4 decks)

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