Clinical research MCQs

1. Rationalism implies all except

[a] It is the pursuit of knowledge through reasoning.
[b] leads to formal truth, which may or may not be materially true.
[c] provides hypothesis for testing.
[d] does not need empirical proof for its conclusions.
Answer d
2. True meaning of Empiricism is
[a] Verification by experimentation and observation.
[b] Practice based on opinion rather than evidence.
[c] No role in the pursuit of knowledge.
[d] Complementary to rationalism.
Answer d

3. The null hypothesis

[a] Is the opposite of the research hypothesis.
[b] Provides, when rejected, susupport for the research hypothesis.
[c] Is a tool in the reasoning process.
[d] All of the above.
Answer -d
4. Which statement is true association of a factor with an
outcome
[a] It is not a proof of causation.
[b] Requires further analysis before considering the factor as the
cause.
[c] Suggests causality if the outcome fails to occur without the factor
[d] All the above
Answer -d
5. Which statement about survey is true
[a] It is a non-interventional study.
[b] It is called case-control if it is retrospective.
[c] If it is prospective, is also called a cohort study.

[d] All the above

Answer d
6 All is true about clinical trials of drugs except
[a] They are interventional studies.
[b] They are experiments.
[c] They can be prospective or retrospective.
[d] They usually have either parallel-groups or cross-over design.
Answer -c
7. Methodological landmarks in clinical trials include
[a] Use of placebo as a control.
[b] Randomization to remove bias in assignment.
[c] Masking of treatment identity to remove bias in assessment.
[d] All the above
Answer d
8. All is true about Declaration of Helsinki except
[a] It is the current ICH standard of ethics in biomedical experiments on
human subjects.
[b] It was revised latest in 2000 at Edinburgh.
[c] It has an explanatory note on the use of placebo as control, issued
in 2002.
[d] It was adopted by the WMA in 1964.
Answer -a

9. The ethics of human experimentation have been outlined by

except
[a] The WHO in Declaration of Helsinki
[b] India in the ICMR guidelines
[c] The CDSCO in its GCP guidelines
[d] The US FDA in its GCP guidelines
Answer -a

10. GCP or good clinical practice

[a] Is applicable only to clinical trials of drugs and devices.

[b] Aims to protect the rights and safety of the research subjects.
[c] Does not aim to prevent fraud and misconduct.
[d] Is outlined in ICF document E3.
Answer b
11 Which of the following would you most often associate
Phase IV Trials
with?
[a] Human Pharmacology
[b] Therapeutic Use
[c] Therapeutic Confirmatory
[d] Therapeutic Exploratory
Answer b
12 In which clinical phase would you generally expect the trials
to be
conducted in a group of patients who are selected by relatively
narrow
criteria, leading to a relatively homogeneous population which
are closely
monitored during the trial and the trial is examining
therapeutic efficacy?
[a] Phase I
[b] Phase II
[c] Phase IIIa
[d] Phase IIIb
Answer b
13 Phase I clinical trial look at the pharmacokinetics of a test
product. Whichof the following statements is not true about
pharmacokinetics?
[a] Pharmacokinetics looks at whether the product demonstrates
efficacy
[b] Pharmacokinetics looks at how the product is excreted from the
body
[c] Pharmacokinetics looks at what the body does to the product
[d] Pharmacokinetics looks at how the product is metabolised by the
body
Answer a

14 A recent development in Clinical Trial Phases has been the

concept of
Phase 0 Trials. Which of the following could potentially be
classified as
Phase 0?
[a] Pre-clinical animal testing
[b] First-in-man to study the pharmacokinetics and drug target effects
of a low subtherapeutic dose
[c] First-in-man trials for medical devices
[d] Trials using human tissue collected from patients but not conducted
in the patient
Answer b

15 Phase I trials often look at ADME of a product. The ADME is

sometimes
extended and referred to as LADME. What does the L stand
for?
[a] Loading
[b] Limiting
[c] Liberation
[d] Limited

Answer c

STU