RESEARCH METHODOLOGY II – MD1402

MIDTERM I – 10/11/23

1. What is blinding?
1. Blinding is when both the patient and the treating
physician know the details of the treatment given
2. Blinding is when knowledge of the treatment given can
influence a patient's response
3. Blinding is when neither the patient nor the treating
physician knows the details of the treatment given
4. Blinding is detection by random locations of patients in
random groups
5. Blinding is the random allocation of patients to
treatments ß randomization

2. What total death or all-cause death in a

population is equal to during a certain period?
1. Death of other reasons but with disease X
2. None of the following
3. All of the following
4. Death due to disease X
5. Death of other reasons without X

3. What is the correct definition of the

measurement error?
1. Attributable risk that can be used as a measure
2. The random allocation
3. Instrument to register or measure a variable
4. The mathematical or algebraic assessments of the
statistical association
5. The deviation from the true value

4. Postmarketing is which phase in the drug

development process?
1. Phase IV

5. Define clinical trials:

1. Clinical trials study the effects of interventions,
so they are experimental studies on humans.
2. The designation clinical trial usually applies to
any type of planned medical experiment
involving humans.
 6. What do measures of importance show?
1. Assesses the definite effects of non-preventive
efforts
2. Based on comparisons between disease
occurrences in groups with various expos…
3. Yield the strength of the association between
the variables, such as between a disease and the
possible cause of it
4. Express the impact of a certain disorder or
exposure on population
5. Used in describing causal relationships and in
descriptive analyses of the evolution of disease
occurrence or mortality over time

7. What are "historical controls"?

1. The comparison is between patients
receiving a new treatment and patients
who previously received a standard
treatment. The patients previously
treated are termed historical controls
2. All of the answers
3. "Historical controls" is a fair comparison
of new and old treatments
4. "Historical controls" is a source of
difference in the patient selection
5. A historical control group is not subjected
to inclusion and exclusion criteria

8. How many categories of the mortality

statistics exist?
1. 10
2. 5
3. 3
4. 14
5. 12

9. Which of the following is NOT part of the principal points

of a protocol?
1. Trial plan
2. Outcome variables
3. Bias
4. Inclusion and exclusion criteria
5. Purpose of the study
10. Vital statistics are used for three main rationales. Which of the following is NOT part of
it?
1. Comparison of age-specific death rates during a
time period
2. Description of the population's vital capacities
3. Description and comparison of cause-specific,
age- and gender-specific death rates for different
groups in the population
4. Comparison of gender-specific death rates
during a time period
5. Description of the population mortality trends

11. What is the definition of objectives for long-term

goals of research strategies?
1. Objectives serve as practical guideposts for
daily, weekly, and monthly research efforts ß
aims
2. Objectives are sufficient conditions for an event
3. Objectives reflect a vision of what the research
seeks to accomplish in the long run ß goals
4. Inference (to a general rule) from particular
instances (cases)
5. Objectives are the most immediate outcomes
of studies

12. How is interim analysis defined?

1. Prognostic factors affecting the treatment effect
2. The conclusive proof that two treatments have different effects
3. The estimation how many patients or people need be enrolled in a specific research
4. The difference in the effects of two treatments
5. An evaluation of the current data from an ongoing trial, in which the primary
research question is addressed, and which has the potential for modifying the
conduct of the study

13. How many categories are epidemiological

measurements classified?
1. 3
2. 5
3. 1
4. 4
5. 2
 14. The importance of the factor may be
assessed when we know…
1. How many of the exposed and how
many of the non-exposed actually are ill or
became ill during a certain period of time
2. How many of only the non-exposed
actually are ill
3. It is not possible to define importance of
the factor
4. How many of the exposed patients are
actually ill
5. Only with number of people became ill
during a certain period of time

15. What are effect measures in cohort studies?

1. The effect measure in cohort studies is the excess risk ratio of survival factor
2. All of the answers
3. The effect measure in cohort studies is the statistical significance of survival factors
4. Cohort studies yield information about risk or incidence rates in exposed and non-
exposed individuals. The effect measures can be either comparisons of risks or the
incidence rates, which by division give relative risks and incidence rate ratios, or by
subtraction give excess risk
5. Cohort studies carry information about survival factors in populations

16. How is a cause of disease defined?

1. None of answers
2. The cause of disease or health damage can be defined as the probability of a certain
event within a certain period that causes illness
3. Homogeneous distributions in which everyone in a population has been exposed to a
factor completely is the cause of disease
4. The constant factor in population is a precondition for defining the cause of disease
5. The cause of disease or health damage can be defined as the factor that alone or in
concert with other factors can bring forth disease or health damage

17. What is the descriptive statistic?

1. The minimal value that says something
about the true and unknown mean of the
population
2. The accuracy of the measurement
methods
3. A summary of the observations from a
sample
4. The magnitude of the sample
5. The maximal value that says something
about the true and unknown mean of the
population
18. What is the correct definition of the selection bias?
1. A systematic deviation of the results where the disease end
2. It is a deviation of the results caused by a skewed selection of the participants
3. It is systematic error that may arise whenever exposure data are used as an
argument for the diagnosis
4. A number of problems with regard to selection
5. It implies that the observed situation exhibits an endpoint

19. What is the randomization of samples?

1. Randomization of samples avoids selection bias
among patients
2. None of the answers
3. Unbiased comparison of treatments is ensured
by random allocation of patients to treatments (or
to sequence of treatments in cross-over studies)
4. Unbiased comparison of treatments is known
allocation of patients to treatments
5. Biased comparison is detected by random
locations of patients in random groups

20. Measures of disease occurrence are:

1. Measures of public health interest, that is, in
assessing the possible effects of preventive efforts
2. Express the impact of a certain disorder or
exposure on a population
3. Used in describing causal relationships and in
descriptive analyses of the evolution of disease
occurrence or mortality over time
4. To yield the strength of the association between
the variables, such as between a disease and the
possible cause of it
5. Based on comparisons between disease
occurrences in groups with various exposures

21. What do "effect measures or

associations" show?
1. Exposure of disease to certain factors
2. Disorder or exposure to illness on a
population dynamics
3. Yield the strength of the association
between the variables, such as between a
disease and the possible cause of it
4. Definite effects of non-preventive
efforts
5. Describes causal relationships and in
descriptive analyses disease development
 22. Name phases in the drug development:
1. Toxicity and side-effects, Dose-response, Comparison
with established treatment, Postmarketing
2. Toxicity and side-effects, Dose-response, Comparison
with established treatment, Statistical analyses
3. Comparison with established treatment,
Postmarketing, Statistical analyses, Risk assessment
4. Toxicity and side-effects, Dose-response, Statistical
analyses, Risk assessment
5. All of the answers

23. What is stratification?

1. Stratification identifies a few
important prognostic factors
2. Stratification or stratified
randomization keeps patient
groups balanced for prognostic factors
3. Within each stratum, patients are randomized in blocks
4. Stratification or stratified randomization keeps patient groups imbalanced for
prognostic factors
5. All of the answers

24. What is the correct definition of the

epidemiology?
1. Epidemiology is the scientific discipline
concerning disease dynamics in the population
2. It is a scientific discipline that only
concerns how health problems can be
controlled
3. Epidemiology is the scientific discipline
concerning only the occurrence and variation
of specific diseases in the population
4. It is a scientific discipline that only
concerns how health problems can be treated
5. Epidemiology is a scientific discipline
concerning the occurrence of disease in the
population
25. Which of the following are the disadvantages of the cross-sectional studies?
1. It can support conclusions on the risk of disease
2. The clearcut definitions may be applied to the exposure and endpoints
3. They permit a large number of variables to be examined
4. It cannot support conclusions on the inference of causality
5. The full of the dimension of time
[Cross-sectional studies provide a snapshot of a population at a specific point in time and
assess the relationship between variables at that particular moment. However, they do not
establish the temporal sequence of events, and therefore, causality cannot be inferred
directly from cross-sectional data. Other study designs, such as longitudinal studies or
randomized controlled trials, are better suited for investigating causal relationships].

26. Name the three most important effect measures of

association in epidemiological studies:
1. Relative risk, Population attributable risk, Odds ratio
2. All of the answers
3. Excess risk, Incidence risk, Attributable risk
4. Relative risk or risk ratio, Odds ratio, Incidence rate
ratio
5. Excess risk, Relative risk, Attributable risk

27. Which of the following is NOT the part of the

three aims of epidemiological studies?
1. Undertaking experiments to assess the
effects of treatments or preventive efforts
2. Describing disease occurrence and
distribution of disease in population groups
3. Describing disease development over time
4. Making research studies
5. Identifying cause of disease

28.

29. Define pilot studies:

1. The pilot study is a miniature version of
the full-scale study that aims to assess its
methods and warn of potential drawbacks
2. The pilot study aims to study full-scale
epidemiology
3. A pilot study is pre sequential study to
reach full-scale objectives
4. A pilot study is a cross-sectional study
that aims to assess its methods and outcomes.
5. A pilot study is a full-scale study that
aims to assess its methods and warn of
potential drawbacks
30. Which of the following can be considered
as gold standard of biomedical research?
1. Temporal aims
2. All of the answers
3. Qualitative aims
4. Descriptive aims
5. Hypothesis-driven aims
 MIDTERM I – 26/04/23

1. The detailed protocol must include information:

1. Aim of the study, its inclusion and exclusion criteria, the treatments and clinical
examinations
2. Number of patients, plan for statistical analyses and reporting of adverse events
3. The evaluation of response to treatment, randomization, blinding
4. All above

2. A detailed protocol must be written

before a clinical trial starts:
1. No
2. Yes

3. The clinical part of the

development of a new drug usually occurs:
1. In one phase
2. In two phases
3. In four phases
4. In three phases

4. Phase I:
1. As a rule, a trial is conducted on a
small group of healthy, volunteer test
subjects
2. Small groups of patients are used to
study the effects of various doses of a
drug
3. Comprises larger clinical trials that
compare the effects of two or more
different treatments, either active
drugs or placebo
4. Postmarketing, covers both long-term
studies of safety and pure marketing
studies

5. Phase II:
1. Postmarketing, covers both long-term studies of safety and pure marketing studies
2. Comprises larger clinical trials that compare the effects of two or more different
treatments, either active drugs or placebo
3. Small groups of patients are used to study the effects of various doses of a drug
4. As a rule, a trial is conducted on a small group of healthy, volunteer test subjects
6. Phase III:
1. Postmarketing, covers both long-term
studies of safety and pure marketing studies
2. Comprises larger clinical trials that
compare the effects of two or more
different treatments, either active drugs or
placebo
3. As a rule, a trial is conducted on a small
group of healthy, volunteer test subjects
4. Small groups of patients are used to study
the effects of various doses of a drug

7. Phase IV:
1. As a rule, a trial is conducted on a small group of healthy, volunteer test subjects
2. Comprises larger clinical trials that compare the effects of two or more different
treatments, either active drugs or placebo
3. Small groups of patients are used to study the effects of various doses of a drug
4. Postmarketing, covers both long-term studies of safety and pure marketing studies

8. What is experimental study?

1. Ones where researchers introduce an
intervention and study the effects
2. All above
3. A type of study in which individuals are observed or certain outcomes are measured
4. Miniature version of the full-scale study

9. What is observational study?

1. All above
2. A type of study in which individuals are
observed or certain outcomes are
measured
3. Miniature version of the full-scale study
4. Ones where researchers introduce an
intervention and study the effects

10. What is pilot study?

1. A type of study in which individuals are
observed or certain outcomes are measured
2. All above
3. Ones where researchers introduce an
intervention and study the effects
4. Miniature version of the full-scale study
11. What is research problem?
1. None above
2. A statement about an area of concern, a condition to be improved, a difficulty to
be eliminated, or a troubling question that exists in scholarly literature, in theory,
or in practice that points to the need for meaningful understanding and deliberate
investigation
3. Question that a study or research project aims to answer
4. Broad statement indicating the general purpose of your research project

12. A statement about an area of concern, a condition to be improved, a difficulty to be

eliminated, or a troubling question that exists in scholarly literature, in theory, or in practice
that points to for meaningful understanding and deliberate investigation…
1. Is research problem
2. Is research question
3. Is research aim
4. Is research goal

13. Find the correct answer: basic requirements of a research problem…

1. Hypotheses (structured ideas) should be
testable
2. Clear description goals and specific aims
3. All above
4. The problem should be amenable to data
collection, and the methods selected should
be those most efficient in testing the
hypotheses

14. What is research question?

1. A statement about an area of concern, a
condition to be improved, a difficulty to be
eliminated, or a troubling question that
exists in scholarly literature, in theory, or in
practice that points to the need for
meaningful understanding and deliberate
investigation
2. Broad statement indicating the general
purpose of your research project
3. Question that a study or research project aims to answer
4. None above
15. What is a research aim?
1. Broad statement indicating the general
purpose of your research project
2. None above
3. Question that a study or research project aims
to answer
4. A statement about an area of concern, a
condition to be improved, a difficulty to be
eliminated, or a troubling question that exists
in scholarly literature, in theory, or in practice
that points to the need for meaningful
understanding and deliberate investigation

16. What is basic medical research?

1. It is research that usually is conducted in
medical, dental or veterinary schools or
institutes
2. It is research with the aim of eliciting
deeper understanding of fundamental
normal or pathological processes
3. All above
4. It is research conducted at the molecular, cellular, organic and organismic level

17. Medical research is research that usually is conducted in medical, dental or veterinary
schools or institutes.
1. No
2. Yes

18. Hypothesis in research:

1. It might be tested or not
2. None above
3. Must be tested
4. Never tested

19. What is randomisation in research?

1. Aim of research
2. Findings
3. Random allocation of the patients
4. Goal of research

20. What is the purpose of randomisation?

1. To prevent systematic differences
between the treatment groups
2. Random allocation of the patients
3. Findings
4. Goal of research
21. What is placebo in research?
1. An inactive substance that looks like the drug or
treatment being tested
2. Number of experiments
3. Number of participants
4. Number of researches

22. What is sample size in research?

1. Number of researches
2. Number of experiments
3. Number of participants
4. None above

23. What is double-blind in research?

1. Both the patient and the treating physician knows
the details of the treatment given
2. Neither the patient nor the treating physician
knows the details of the treatment given
3. Only treating physician knows the details of the
treatment given
4. Only patient knows the details of the treatment
given

24. What means 1:1 in medical research?

1. The research aim and goal are the same
2. The research question and goals are the same
3. Question and goals are the same
4. None above
5. Placebo and the control groups are the same size

25. Successful medical research projects are characterized

by:
1. Adequate and effective methodology
2. Clearly stated problems
3. All above
4. By relevant questions

26. Research goals reflects from:

1. Hypotheses
2. Vision of what the research seeks to accomplish in
the long run
3. The problem
4. Findings
27. Literature review for a research project:
1. If necessary, go back 100 years - significant discoveries in anatomy, histology and
physiology were made that long ago
2. None above
3. Limit the review to papers that are available only
electronically.
4. It is not mandatory for research project

28. Find the correct answer: in the literature review for a

research project:
1. Do not limit the review to papers that are
available only electronically
2. Literature review in not mandatory for research
project
3. None above
4. Limit the review to papers that are available only electronically

29. Clinical trial usually applies:

1. To any type of planned medical experiment NOT
involving humans
2. To any type of planned medical experiment
involving humans
3. All above
4. To any type of planned medical experiment
involving plants

30. The intent of a clinical trial is:

1. None above
2. To make a pilot research
3. To determine which treatment is best suited for patients with a specific diagnosis
4. To formulate research question