BCBR - Review + Cycle 3 - DR Amith M Shah

Basic Course in
Biomedical
Research –
Review
Dr. Amit M Shah

Associate Professor
Department of Pharmacology
GMERS Medical College
Gandhinagar
M: 9974820709
Contents
Lecture 1: Introduction to health research 2
Lecture 2: Formulating research question 7
Lecture 3: Literature review 11
Lecture 4: Measures of disease frequency 15
Lecture 5: Descriptive study designs 19
Lecture 6: Analytical study designs 23
Lecture 7: Experimental study designs: Clinical trials 29
Lecture 8: Validity of epidemiological studies 33
Lecture 9: Qualitative research methods: An overview 38
Lecture 10: Measurement of study variables 43
Lecture 11: Sampling methods 47
Lecture 12: Calculating sample size and power 52
Lecture 13: Selection of study population 57
Lecture 14: Study plan and project management 61
Lecture 15: Designing data collection tools 65
Lecture 16: Principles of data collection 69
Lecture 17: Data management 72
Lecture 18: Overview of data analysis 76
Lecture 19: Ethical framework for health research 80
Lecture 20: Conducting clinical trials 85
Lecture 21: Preparing a concept paper for research projects 88
Lecture 22: Elements of a protocol for research studies 93
Lecture 23: Publication Ethics 97
Basic Course in Biomedical Research – Review (Compiled by Dr. Amit M Shah) 1

Lecture 1: Introduction to health research

1. Which of the following areas can be included in health b) Shipment of samples and transfer of data outside the
research? country
i. Improving the health of the population. c) Sharing and protection of intellectual property
ii. Predicting progression of a disease in a patient d) All of the above
iii. Prevention of various diseases
iv. To explore various societal, community based and 5. Which of the following statements is not true in case of
programmatic interventions for disease prevention pilot study?
and control a) They are conducted for developing and testing
a) i and ii adequacy of research instruments
b) i, ii and iv b) They establish whether the sampling frame and
c) All of the above technique are effective
d) None of the above c) Ethics committee approves the main study only
after successful completion of the pilot study
2. What is appropriate for sample and sample size? d) They are small scale studies
a) Should be representative of the population [External
validity or generalizability] 6. Before initiating a study involving primary data
b) Should be adequate [power to draw meaningful collection, the Principal Investigator must ensure that
inferences] various approvals are obtained. Which of the following
c) Both 'a' and 'b' approvals is absolutely mandatory?
d) Neither 'a' nor 'b' a) Scientific committee approval
b) Ethics committee approval
3. Which of the following statements are correct c) Technical committee approval
regarding defining inclusion and exclusion criteria in a d) Regulatory authority approval
study protocol?
a) They should be vague because this will allow greater 7. Which is the best source of information on 'effect
and easy enrollment modifiers' while exploring cause and effect
b) They should be very specific relationship in a research study?
c) They should be very large in number a) Deductive thinking
d) It is not important to define exclusion criteria in a b) Thorough review of literature
clinical trial c) Intelligent guessing
d) Discussing with experienced researchers
4. Which of the following are examined as part of
regulatory review? 8. The policy makers want to know whether introduction
a) Information regarding transfer of funds and of pentavalent vaccine in the national program is
utilization of funds resulting in reduction in the number of Hemophilus

influenza cases. Which of the following studies will they immunization programme is resulting in reduction of
have to conduct to find an answer? morbidity and mortality from rotavirus disease. Which
a) Case-control study of the following studies will they have to conduct to
b) Field trial find an answer?
c) Ecological study a) Case-control study
d) Case series b) Ecological study
c) Field randomized trial
9. What is true about Confounders? d) Case-series
a) They affect both study variable as well as outcome
16. What effect does increasing the sample size have upon
b) Their effect can be minimized by proper study
the random error?
design and through stratified analysis
a) It increases the random error
c) Both 'a' and 'b'
b) It has no effect on the random error
d) None of the above
c) It reduces the random error
10. Which of the following is not a type of study design?
a) Qualitative study 17. Which of the following will best describe the scientific
b) Observational study inquiry that seeks to understand the acceptability and
c) Retrospective study functionality of a health program?
d) Pilot study a) Basic science research
b) Translational research
11. Any systematic error in the design, conduct or analysis c) Clinical research
of a study that results in an erroneous estimate of an d) Implementation research
exposure's effect on the risk of disease is called: e) None of the above
a) Confounding
b) Bias 18. The following statements describe confounding and
c) Interaction effect modification. Which of the statement is/are
d) Stratification correct?
a) In a study of relationship between coffee
12. Which of the following is not part of ethics review of a drinking and oro-pharyngeal cancer; smoking
project? is a confounder
a) Informed consent document and procedure b) In a study to explore relationship between
b) Competence of researcher and institute hepatitis B infection and post-infection hepatic
conducting research sequelae, habit of alcohol drinking acts as an
c) Sharing and protection of intellectual effect modifier and patients with this habit
property may be excluded from the study
d) Care and support during and after completion c) 'a' and 'b' are correct
of research d) 'a' and 'b' are wrong
13. A study was conducted to assess the extrapyramidal 19. Issues regarding shipment of samples and transfer of
side effects of a new antipsychotic drug in patients with data outside the country are examined by:
schizophrenia. Many of these patients were smokers a) Regulatory review
and some of them were on anticholinergic drugs. What b) Ethics review
was the role of the anticholinergic drugs in this study? c) Scientific review
a) Confounder d) None
b) Random Variable
c) Effect Modifier 20. Which of the following disciplines contribute to health
d) Independent Variable research?
a) Bio-medical research
14. Before initiating the study, the Principal Investigator b) Biostatistics
must ensure that various approvals are obtained. c) Social science research
Which of the following approvals is/are absolutely d) All of the above
mandatory?
a) Scientific committee approval 21. Which of the following best describes a study done in a
b) Ethics committee approval laboratory setting using animals?
c) Technical committee approval a) Translational research
d) Regulatory authority approval b) Bench-based research
e) All c) Theoretical research
d) Preventive research
15. The policy makers want to know whether introduction
of a new rotavirus vaccine in the national

22. Which of the following review is NOT essential before 27. Which of the following is NOT a component of a
initiating a clinical trial? research study?
a) Scientific review a) Setting up the institute scientific
b) Peer review committee
c) Regulatory review b) Calculating sample size
d) Ethics review c) Development of a study tool
d) Framing the research question
23. Which of the following is NOT a type of study design?
a) Qualitative study 28. A researcher wants to study the relationship between
b) Observational study COVID-19 infection in pregnancy and birth weight.
c) Retrospective study Currently, there is no evidence on this topic. Which of
d) Translational study the following options is the scope of this health
research?
24. Which of the following statements is NOT correct a) Verifying and confirming known information
regarding errors in a health research? b) Getting additional or new information
a) Random error is due to chance c) Evaluating ongoing programs
b) Systematic error is due to bias d) All of the above
c) Random errors can be eliminated by
improving study design 29. Which of the following is NOT a critical consideration
d) Bias distorts the study results in one direction in planning a health research?
a) Adequate justification
25. State whether true or false. Assigning roles and b) Clear and focussed research question
responsibilities to the team members is one of the c) Standard case definitions
fundamental principles of a research d) Financial gain
a) True
b) False 30. Identify the CORRECT statement about
implementation of a research
26. Health research is usually focused on which of the a) Research findings must be approved by the
following areas? funder
a) Estimation of disease burden in a population b) Research finding must be error free
b) Prevention of common diseases in the c) Adequate sample size is a prerequisite
community d) Pilot study can be done during data analysis
c) Evaluation of public health programs stage
d) All the above

Lecture 2: Formulating research question

1. Which of the following is an element of life cycle of purpose?
research? a) Research question
a) Identify data needs and spell out the research b) Objectives
question c) Research hypothesis
b) Formulate the objective and design the study d) All of the above
c) Draw conclusion and give recommendation to
stakeholders 5. If your objective is to estimate the prevalence of a
d) All of the above health problem in a community in 2019, Identify the
type of research question this
2. Which of the following verbs is preferably used in the study is addressing
statement of objectives of an analytical research a) Analytical research question
study? b) Descriptive research question
a) Estimate c) Hypothetical research question
b) Determine d) Experimental research question
c) Study
d) Describe 6. What is the first step in the life cycle of research?
a) Spell out the research question
3. Source(s) of research question is/are b) Formulate the objective of the study
a) Published literature c) Identify the data needs
b) Being alert to new ideas d) Choose the study design
c) Careful observation and teaching
d) All of the above 7. A clear research question facilitates to do the following
a) Choose the most optimal design
4. Which of the following is stated mainly for statistical b) Identify who should be included as study population

c) Specify the outcomes that should be measured hypothesis
d) All of the above a) True
b) False
8. Which of the following statements is incorrect?
a) A good research question should be Feasible, 16. Identify the type of research question if the objective of
Interesting, Novel, Ethical and Relevant a study is " To determine the effect of tobacco cessation
b) A good research question should be in services on tuberculosis treatment outcomes among
epidemiological terms patients with tuberculosis under National Tuberculosis
Elimination Program"?
c) A good research question facilitates to choose
a) Descriptive research question
optimal design
b) Hypothetical research question
d) A good research question will focus on one issue
c) Analytical research question
d) Experimental research question
9. The verb "estimate" is used in the objective of
analytical research studies 17. As per the following objectives a hypothesis should be
a) True stated for which study?
b) False a) To determine the association of maternal
smoking during pregnancy with respiratory
10. The process of refining the "ideas" into research infectious disease morbidity and mortality in
questions begins with general uncertainty about a infants
health issue and narrow down to a specific, concrete b) To estimate the lifetime prevalence of mental
researchable issue health morbidities among elderly people in India
a) True c) To describe the pattern of physical activity among
b) False school going children aged 6-18 years
d) To describe the temporal and spatial trends of
11. Which of the following statement is incorrect about a mortality due to cardiovascular diseases, by age
good research question? and sex in India during 2009-2019
a) Research question should advance scientific
knowledge, improve practice, influence policy 18. All the following are components of 'FINER ' criteria for
b) Research question should be approved by the a research question EXCEPT
ethics committee a) Feasible
c) Research question should confirms, refutes or b) Reliable
extends previous findings c) Novel
d) Feasibility should not be a criterion while d) Ethical
developing research question
19. Which is the last step in the life cycle of research?
12. All the following are characteristic of good research a) Spell out the research question
hypothesis EXCEPT b) Formulate the objective of the study
a) Research hypothesis should be simple c) Formulate recommendations
b) Research hypothesis should be devoid of any d) Choose the study design
ambiguity about study participants and variables
c) Research hypothesis should be focused on primary 20. The following are the steps in framing a research
objective question.
d) Research hypothesis should be written once I. Review of state-of-art information
the study is completed II. Define measurable exposures & outcomes
III. Raise a question
13. Which of the following verb is used in the statement of IV. Decide worth investigating by peer-review
objective of a descriptive research study? Choose the correct sequence of framing a research
a) Estimate question from below.
b) Determine a) I, II, III, IV
c) Examine b) II, IV, III, I
d) Compare c) I, III, IV, II
d) III, I, II, IV
14. A research question states about what the results of the
study might ultimately contribute to that particular 21. A clear research question is required in order to
field of science facilitate the following:
a) True a) To choose an optimal study design
b) False b) To identify the outcomes that need to be measured
c) To decide when the outcomes need to be measured
15. Purely descriptive research questions do not require a d) All the above

a) True
22. Characteristics of a good hypothesis are all, EXCEPT: b) False
a) There should be no ambiguity about the study
variables 27. Which of the following statement about study
b) It should be stated ‘a priori’ objective/s is FALSE?
c) It can be revised based on the study findings a) Objectives are stated in scientific terms
d) It should specify one exposure and one outcome b) Objectives can be primary and secondary
c) Each objective is written using multiple verbs
23. Which of the following is NOT an ideal source of a d) Objectives should be specific
research question?
a) Reviewing the published literature 28. In the life cycle of research, ‘spelling out the research
b) Attending conferences where latest findings are question’ is followed by-
shared a) Preparing data collection instrument
c) Observing keenly in the out-patient clinic b) Formulating study objectives
d) Mining existing datasets for research question c) Collecting data
d) Formulating recommendations
24. Which of the following is TRUE for a ‘Descriptive
Research Question’? 29. How can the given study objective be improved?
a) Involves observations to measure a quantity “To understand the anaemia in pregnancy”
b) Involves comparison groups a) Using appropriate action verb
c) Tests the efficacy of interventions b) Specifying the outcome measure
d) Requires hypothesis testing c) Specifying the study setting and time period
d) All the above
25. Which of the following characteristics best describe a
good research question? 30. Which of the following is NOT a step in framing an ideal
a) Feasible, Novel, Ethical research question?
b) Feasible, Noble, Ethical a) Literature review
c) Ethical, Novel, Intuitive b) Peer review
d) Fantastic, Novel, Relevant c) Broadening the initial question
d) Defining measurable outcomes
26. State whether true or false. A research study is
conducted to estimate the seroprevalence of COVID-19
in Ahmedabad city during April-June 2020. This is an
example of analytical research question.

Lecture 3: Literature review

1. The ability to apply the principles of analysis to identify potentially useful articles and books is called as
those studies which are unbiased and valid is called as a) Information seeking
a) Critical appraisal b) Critical appraisal
b) Information seeking c) Database management
c) Information management d) Information retrieval
d) Systematic Review
5. In the Boolean search strategy AND tells that database
2. A __________ is a collection of articles, abstracts, scientific that you want records that contain all the words you
proceedings, books, citations etc. that is organized so specify
that it can easily a) True
be accessed while doing literature review b) False
a) Database
b) Critical appraisal 6. Which of the following is unethical while writing a
c) Hard disk Literature Review?
d) Index a) The contents from the studies should be presented
honestly
3. Why should we need to do a literature review? b) The contents from the studies should not be
a) Save yourself from work distorted
b) Know the subject matter better c) It is not necessary to address the weakness of the
c) Suggest new research topics, questions and methods study in a scholarly manner
d) All of the above d) Sources should be accurately documented
4. The process of scanning the literature efficiently using 7. Critical appraisal is done in an organized and
manual or computerized methods to identify a set of systematic manner

a) True b) Methods
b) False c) Results
d) Discussion
8. The process of identifying, within a large document
collection, a subset of documents whose content is 15. Which of the following about PubMed is incorrect?
most relevant to user's need is called as a) PubMed comprises more than 25 million citations
a) Information retrieval for biomedical literature
b) Information management b) Citations may include links to full-text article from
c) Systematic Review PubMed Central
c) PubMed is developed and maintained by the
d) Narrative Review
National Centre for Biotechnology Information
(NCBI), at the U.S. National Library of Medicine
9. The query system in the information retrieval process
(NLM)
of literature review is
d) PubMed is a paid service provider for
a) User defined
searching of literature
b) Provider defined
c) Conditional 16. All the following are examples of databases EXCEPT
d) Not structured a) MEDLINE
b) EMBASE
10. In the National Library of Medicine (NLM), MeSH c) CINAHL
means d) Google scholar
a) Medical Services Heading e) None of the above
b) Medical Subject Heading
c) Medical Subject Helpline 17. Literature searches are important to do at the start of a
d) Medicine Services Helpline project; and do not need to continue throughout the
project.
11. In literature review method of identifying studies a) True
which are unbiased and valid is known as critical b) False
appraisal.
a) True 18. Which of the following search query should be used to
b) False find the articles on chest pain other than angina?
a) Chest pain AND angina
12. Choose the correct sequence of the steps of b) Chest pain OR angina
systematically doing literature search from below c) Chest pain NOT angina
a) Organize the information, identify the lacunae, d) Chest pain EXCEPT angina
develop the research question, synthesize the
results 19. A researcher wants to assess effects of polyunsaturated
b) Identify the lacunae, develop the research fatty acids (PUFA) on diabetes prognosis. For this, the
question, synthesize the results, organize the researcher searches related articles in PubMed and
information Google scholar. This process is known as
c) Develop the research question, synthesize the a) Information retrieval
results, organize the information, identify the b) Indexing
lacunae c) Critical appraisal
d) Organize information, synthesize the results, d) Data management
identify the lacunae, develop the research
question 20. Which of the following about MeSH is incorrect?
a) MeSH thesaurus is controlled vocabulary
13. All the following about literature review is correct produced by the National Library of Medicine
EXCEPT b) It consists of sets of terms naming descriptors in
a) It identifies lacunae in the existing knowledge a hierarchical structure that permits searching at
about a topic various levels of specificity
b) It saves valuable time for a researcher c) It is used for indexing and searching of biomedical
c) It helps the researcher in arriving the and health-related information
conclusion of a study d) MeSH is used for EMBASE database
d) It suggests the researcher about new research
topics 21. Which of the following is INCORRECT about literature
review for a proposed study?
14. While drafting a scientific manuscript, literature a) Begins with a systematic literature search
review is useful on the following section EXCEPT b) Involves critical appraisal of retrieved studies
a) Introduction c) Presents existing knowledge concisely

d) Guides the findings of the proposed study relevant to the research question within a large
document collection. This process is known as-
22. A researcher conducts a review of literature to identify a) Information management
a set of potentially useful articles and books related to b) Critical appraisal
their research topic. This process is known as- c) Information retrieval
a) Indexing d) Literature organization
b) Critical appraisal
c) Data management 27. The organized collection of articles, abstracts, scientific
d) Information seeking proceedings, books, and citations used for the purpose
of literature review, is known as-
23. Literature review is a well thought out and organized a) Database
search for all literature published on a particular topic b) Data management
in a library or online database. c) Critical appraisal
a) True d) Index
b) False
28. Which of the following does not satisfy the ethical
24. Which of the following search query in PubMed will principles in conducting a literature review?
give relevant articles for the following question? a) Results of previous studies are presented without
“What is the burden of gastroenteritis among distortion
children?” b) Weaknesses of previous studies are highlighted
a) Gastroenteritis OR children c) Previous studies are accurately cited
b) Gastroenteritis AND children d) Reputation of study authors are questioned
c) Gastroenteritis BUT children
d) Gastroenteritis NOT children 29. For which of the following purpose is the Boolean
operator ‘OR’ commonly used in literature search?
25. Which of the following Boolean operator will give the a) Connecting synonyms of one key concept
highest number of results when used between two b) Connecting different key concepts
given search terms? c) Connecting keywords which need to be excluded
a) AND d) Connecting keywords to narrow down the results
b) NOT
c) OR 30. Medical Subject Headings is a controlled vocabulary
d) ALL thesaurus used for indexing articles in
a) PubMed
26. A researcher wants to study the effect of physical b) Google scholar
activity on reduction of systolic blood pressure among c) Scopus
patients with hypertension. The researcher has d) Health on Net
identified a subset of document which are most

Lecture 4: Measures of disease frequency

1. Which of the following must be considered while of autism per 1000 children
measuring occurrence of a disease? a) 4.01
a) The number of people affected by the disease b) 5.53
b) The population size from which the cases of disease c) 3.35
arise d) 4.71
c) The length of the time the population is followed
d) All of the above 10. Statistic used to estimate the risk of acquiring a disease
a) Prevalence
2. __________ is most useful for evaluating the impact of b) Incidence
prevention programmes c) Mortality rate
a) Point prevalence d) All of the above
b) Period prevalence
c) Case fatality 11. What is the appropriate measure when a researcher
d) Incidence wishes to know the burden of a particular disease in
terms of the number of deaths it causes in a specified
3. Which one of the following statements is true? geographical region and population?
a) High cure rate can increase the prevalence of a a) Incidence density
disease b) Case fatality
b) Low case fatality can reduce the prevalence of a c) Attack rate
disease d) Disease specific mortality
c) Both 'a' and 'b' are true
d) High cure rate and high case fatality can reduce 12. If health policy makers want to evaluate the impact of a
the prevalence of a disease prevention program, which is the appropriate measure
to be considered?
4. Measures of disease frequency a) Period prevalence
a) Incidence b) Incidence
b) Prevalence c) Point prevalence
c) Birth rate d) Case fatality
d) 'a' and 'b'
13. Select the correct statement among the following
5. A measure that reflects severity of an acute infectious a) Prevalence of a disease will increase when it has a
disease high cure rate
a) Case fatality ratio b) Prevalence of a disease will decrease when it has a
b) Incidence rate low case fatality ratio
c) Prevalence c) Prevalence of a disease will increase when it has
d) Mortality rate a low cure rate
d) Prevalence of a disease will increase when it is acute
6. Incidence data can be used to measure the occurrence in nature
of disease with gradual onset
a) True 14. What is the appropriate epidemiologic measure to
b) False determine the severity of an acute disease?
a) Incidence rate
7. This measure reflects the impact of a disease on b) Prevalence
population in terms of death c) Mortality rate
a) Incidence density d) Case fatality ratio
b) Case fatality
c) Disease specific mortality 15. Cumulative incidence is otherwise known as
d) Attack rate a) Attack rate
b) Case fatality rate
8. While measuring the frequency of a chronic disease in a c) Mortality rate
community in terms of Incidence per 1000 persons per b) Morbidity rate
year, and point prevalence per 1000 persons, what is
the expected pattern of incidence and prevalence? 16. The healthcare professionals working in an intensive
a) Low prevalence, high incidence care unit were asked whether there has been an
b) High prevalence, low incidence increase in the number of new pneumonia cases. Which
c) Both prevalence and incidence will be similar of the following factor(s) is inappropriate in the
d) None of the above statements are true calculation of cumulative incidence?
a) Number of new cases of pneumonia during a specific
9. In a study among 3400 children aged 5-10 years, 16 period of time
children were diagnosed with autistic disorder. b) Total number of people at risk of developing the
Calculate the prevalence disease in that population during the same period of
time

c) Pre-existing cases of pneumonia 24. A total of 100 people with hypertension were followed
d) Both ‘a’ and ‘b’ up for 3 years to observe for the development of
myocardial infarction in a cohort study. At the end of
17. When measuring the frequency for an acute infectious first year, 10 people developed myocardial infarction, at
disease in a community in terms of incidence per 1000 the end of second year, 10 people left the study and at
persons per year and point prevalence per 1000 the end of third year, another 10 people developed
persons, how will the pattern of incidence and myocardial infarction. Calculate the total person-years
prevalence be? of observation in this study?
a) High prevalence a) 250
b) Low incidence b) 260
c) Both prevalence and incidence will be similar c) 270
d) Low prevalence and high incidence d) 280
18. Among 25000 population in a city, 105 residents were 25. During a one-year follow-up, a psychiatrist determined
identified with Hepatitis B infection. Calculate the the burden of suicidal ideation among 100 patients with
prevalence of Hepatitis B per 1000 population. drug addiction. Seven patients had previous history of
a) 5.2 suicidal ideation and 20 patients developed it for the
b) 4.2 first time. What is the incidence of suicidal ideation in
c) 3.2 the study population?
d) 2.2 a) 7% per year
b) 20% per year
19. Which of the following condition tends to increase the c) 21.5% per year
prevalence of a particular disease? d) 27 per year
a) High cure rate
b) Low case fatality ratio 26. In a food poisoning outbreak, 75 people were affected.
c) Short duration Among them, 50 were hospitalized, and two died.
d) Emigration of patients Calculate the case-fatality ratio.
a) 1.2%
20. Which of the following is true about incidence density? b) 2.7%
a) Numerator has number of new cases c) 4%
b) Also called cumulative incidence d) 8%
c) Denominator is number of persons at risk
d) Numerator has person-years at risk 27. Which of the following is NOT required for calculating
prevalence of a disease?
21. In a rural block with 1,00,000 population, 250 residents a) Pre-existing cases of the disease
were identified with cardiovascular disease. Calculate b) New cases of the disease
the prevalence of cardiovascular disease per 1000 c) Total number of people at risk
population. d) Total person-time of observation
a) 0.2
b) 0.5 28. Which of the following condition tends to reduce the
c) 2.5 prevalence of a particular disease?
d) 25 a) High cure rate
b) Low case fatality ratio
22. What is the appropriate epidemiologic measure to c) Improved case detection rate
determine the burden of a disease in terms of number of d) Immigration of diseased people
cases present in a specified geographical area at a
specific point in time? 29. In which of the following conditions, prevalence is an
a) Cumulative Incidence appropriate measure of disease frequency?
b) Point Prevalence a) Common cold episodes in elderly
c) Incidence rate b) Number of exacerbations in asthma patients
d) Case fatality ratio c) Proportion of foot ulcers in Diabetes Mellitus
d) Number of diarrhoea episodes in children
23. In a study, 300 children were followed up for a period of
one year to determine the burden of acute respiratory 30. Which of the following is INCORRECT about case
infections (ARI). Calculate the incidence density if the fatality?
total number of ARI episodes recorded was 1500. a) It reflects the severity of a disease
a) 5 episodes per child year b) High case fatality indicates poor prognosis
b) 0.2 episodes per child year c) It relates the number of deaths to the number of cases
c) 3 episodes per child year of a disease
d) 0.5 episodes per child year d) It is a true rate

Lecture 5: Descriptive study designs

1. Study design(s) useful for describing uncommon 5. Which of the following is wrong about descriptive
clinical manifestations study designs?
a) Case reports a) Describe the study outcome for 1 group
b) Case series b) Compare the study outcomes for 2 group
c) Both 'a' and 'b' c) Calculate the incidence for surveillance data
d) Ecological study d) Calculate prevalence for cross-sectional study
2. Cross-sectional studies are used to 6. Descriptive epidemiology study designs can answer all
a) Estimate prevalence of the following questions EXCEPT:
b) Generate hypotheses a) Who?
c) Describe trends b) When?
d) All of the above c) Where?
d) Why?
3. In a cross-sectional study, we can observe one or more
outcomes 7. Which one of the following study designs does not
a) True employ comparison groups to answer the primary
b) False study objectives?
a) Cross-sectional study
4. Which one of the following is useful to measure the b) Cohort study
burden or magnitude of a disease or risk factor? c) Ecological study
a) Case-control study d) Clinical trials
b) Cross-sectional study
c) Case report 8. Unit of observation in the cross-sectional study is
d) Case series a) Individual

b) Group to establish the efficacy of the surgical device because
c) Both 'a' and 'b' a) There is no comparison group
d) None of the above b) There is no information of risk factors
c) We do not have details of the outcome
9. Case reports can include presentation of d) We do not have individual level data
a) Unique features/symptoms of a disease
b) Rare manifestation of common disease 17. Population census is a
c) New or unfamiliar diseases a) Cross sectional survey
d) All of the above b) Ecological study
c) Analytical study
10. Advantage of the ecological study is
a) Relate rate of disease and exposure
18. One of the major limitations of a cross-sectional study
b) Useful to test hypothesis
is that
c) Useful to study rare diseases
a) It is time consuming
d) All of the above b) It has lower validity
c) It does not establish disease etiology
11. A researcher can assess the following by conducting a d) It requires a large sample size
descriptive study EXCEPT
a) Population in which the disease was prevalent 19. Characteristic of a cross sectional study is that
b) Period in which the disease occurred a) We can calculate the incidence of a disease
c) Risk factors of the disease b) We can test a hypotheses
d) Place distribution of the disease c) It is difficult to conduct
d) Exposure and outcome are assessed at the same
12. The following study design provides group exposure time
and group response/outcome without knowing the
individual exposure and response for a specific health 20. If a researcher wishes to estimate the incidence of
problem Myocardial infarction cases among a group of women
a) Ecological study using oral contraceptive pills followed up for 10 year,
b) Cross sectional survey the researcher has to carry out
c) Case report a) Case series
d) Case series b) Cohort study
c) Cross sectional study
13. Which of the following study design will be helpful if d) Ecological study
the department of health wants to know the burden of
a particular disease? 21. Case series are useful-
a) Ecological study a) To estimate burden of a disease
b) Cross sectional survey b) To determine risk factors of a disease
c) Case series c) To determine efficacy of a new drug
d) Case report d) To describe uncommon clinical manifestation
14. A clinician comes across an unusual presentation of a 22. All the following are true about cross-sectional survey,
particular neurological disorder. If the clinician EXCEPT-
describes this single case in detail and publishes the a) Individual is the unit of observation
same in a journal, then it will be called b) Involves only incident cases
a) Analytical study c) Estimate the burden of a disease
b) Case report d) It can be used to generate hypothesis
c) Cross sectional survey
d) Ecological study 23. A detailed presentation of a single case which is rare
and unfamiliar, is called-
15. The advantage of an ecological study is that a) Case report
a) It is analytical in nature b) Case series
b) It will cover individual level information on risk c) Ecological study
factors and disease d) Cross-sectional study
c) It will be useful to test hypotheses
d) It will be useful to generate hypotheses 24. Which of the following is INCORRECT about ecological
study?
16. In a tertiary care hospital, a surgeon collected a) It relates the rate of disease and frequency of
information on quality of life and outcome among a exposure
small group of (about 15) post-operative patients after b) It is an example of observational study
using a novel surgical device. But this is not sufficient

c) It uses individual level data b) Case series
d) It helps in generating hypothesis c) Case control study
d) Ecological study
25. Which of the following is NOT applicable in a case
study? 28. Which of the following is FALSE about cross-sectional
a) Clinical features studies?
b) Laboratory parameters a) Can be used to generate hypothesis
c) Socio-demographic background b) Can be used to establish temporality of association
d) Incidence c) Can be used to estimate disease burden
d) Can be used to identify factors associated with
26. To determine the association between air pollution and outcome
male infertility, data on air quality index and
prevalence of male infertility was collected for 183 29. State whether true or false. Descriptive cross-sectional
countries for the year 2019. What best describes the study does not have a comparison group.
study? a) True
a) Case report b) False
b) Case series
c) Ecological study 30. Which of the following studies can be used to identify
d) Cross-sectional study the factors associated with an outcome?
a) Descriptive cross-sectional study
27. In a medical journal, 18 cases of Creutzfeldt Jakob b) Analytical cross-sectional study
disease were reported from a tertiary care hospital in c) Case study
Sikkim. The authors of the paper gave a description of d) Case series
the socio-demographic, clinical, and laboratory
features of the 18 patients. What best describes this
study design?
a) Case study

Lecture 6: Analytical study designs

1. Exposure is not assigned by the investigator in the 8. Which of the following is NOT true regarding case-
following study design control study?
a) Cohort i. Appropriate for study of rare outcome
b) Case-control ii. More time consuming than cohort study
c) Cross-sectional iii. Multiple exposures can be examined
d) All of the above iv. Relatively expensive compared to cohort study
a) Both (i) and (ii)
2. Which of the following statement(s) is true about the b) Both (ii) and (iii)
cohort study? c) Both (ii) and (iv)
a) It is not suitable for disease with a long latency d) Both (iii) and (iv)
period
b) Loss to follow up can introduce bias 9. What is an appropriate measure of statistical
c) Both 'a' and 'b' association in a cohort study?
d) None of the above a) Prevalence ratio
b) Risk ratio
3. Which of the following study design is better suited to c) Odds ratio
demonstrate a temporal association between exposure d) Pearson's correlation coefficient
and disease?
a) Cross-sectional study 10. The entire population of a given community is screened
b) Case-control study and all those judged as being free of Colon cancer are
c) Cohort study questioned extensively about their diet. These people
d) Ecological study are then followed-up for several years to see whether
their eating habits will predict their risk of developing
4. Relative risk of more than 1 indicates Colon cancer - This is an example of
a) Incidence in unexposed is higher than exposed a) Case-control study
b) Incidence in exposed and unexposed are same b) Clinical trial
c) Incidence in exposed is higher than unexposed c) Cross-sectional study
d) Relative risk is significant d) Cohort study
11. Exposure is assigned by the investigator in which of the

5. If the odds of exposure among cases is lower than the following epidemiological study?
odds of exposure among the controls, the odds ratio a) Case-control
will be b) Cross-sectional
a) More than 1 c) Experimental
b) Less than 1 d) Cohort
c) It depends on other factors
d) None of the above 12. When a group of people with defined characteristics
are followed up to determine incidence is known as
6. All babies born in a particular year will form a birth a) Case series
b) Cohort
cohort
c) Case control
a) True
d) Experimental
b) False
13. Relative risk is a
7. Cohort study is suitable for rare diseases a) Rate
a) True b) Ratio
b) False c) Proportion

14. Relative risk of one in a cohort study indicates rare diseases
a) Incidence in unexposed is higher than exposed
b) Incidence in exposed is higher than unexposed 21. To determine the associated factors of anti-
c) Relative risk is significant hypertensive drug compliance, an investigator selected
d) Incidence in the exposed and unexposed groups 384 participants with hypertension who were
are same undergoing treatment in a tertiary care hospital. The
investigator collected the details on the socio-
15. Women aged above 35 years were screened for the economic background of the participants and took
HPV (Human papilloma virus) infection and those who history regarding the consumption of medicines in the
had HPV infection were then followed for several years past two weeks. Then the drug compliant group and the
to predict the risk of developing cervical cancer. This non-compliant group were compared to identify
study is known as factors associated with drug compliance. What is the
a) Prospective cohort type of the study design?
b) Retrospective cohort a) Case control study
c) Case control b) Prospective cohort study
d) Cross sectional c) Case study
d) Analytical cross-sectional study
16. Which of the following is appropriate regarding a
cohort study? 22. A gynaecology resident intends to determine the
i. Multiple exposures can be examined association between intra-uterine device (IUD) use and
ii. Appropriate for studying rare exposures risk of extrauterine pregnancy. The investigator
iii. Expensive and time consuming recruited 100 cases of extrauterine pregnancy and 200
iv. Appropriate for studying rare diseases participants who had intrauterine pregnancy as
a) Both (i) and (ii) controls from the obstetrics ward of a tertiary care
b) Both (iii) and (iv) hospital over a period of 2 years. Both cases and
c) Both (ii) and (iv) controls were interviewed about the history of IUD use.
d) Both (ii) and (iii) Among the cases, 6 participants had history of IUD use
and among controls, 4 had history of IUD use. Calculate
17. Which of the following statement regarding the cohort the odds ratio of extrauterine pregnancies among
study is FALSE? women with history of IUD use?
a) Suitable to study a disease with long latency a) 0.32
period b) 1.39
b) Loss to follow up can introduce bias c) 3.12
c) Relative risk can be calculated d) 0.72
d) Temporal association with the risk factor can be
established 23. An investigator conducted a case control study with
psoriasis patients as cases and other skin disease
18. Odds ratio of more than one indicates patients as controls. Those having hypertension were
a) Odds of exposure among cases is lower than the odds considered as exposed and non-hypertensives as non-
of exposure among the controls exposed. The study found an odds ratio of 1.45. Which
b) Odds of exposure among cases is equal to the odds of the following is correct?
of exposure among the controls a) Psoriasis is positively associated with
c) Odds of exposure among cases is higher than the hypertension
odds of exposure among the controls b) Odds of hypertension among psoriasis patients is
d) Exposure is negatively associated with the disease lower than the odds of hypertension among patients
without psoriasis
19. If there is a comparison group in an epidemiological c) Odds of psoriasis among hypertensive patients is
study design, it is called lower than the odds of psoriasis among non-
a) Descriptive hypertensives
b) Analytical d) Hypertension is a causative factor of psoriasis
c) Ecological
d) None of the above 24. A prospective cohort study was conducted to
determine the association between coffee consumption
20. Which of the following statements about case and risk of pancreatitis among 10000 healthy
control/cohort studies is correct? participants. Among the participants 3500 participants
a) Case control study always establishes temporal consumed coffee, whereas 6500 participants did not.
association After a follow up of 10 years 85 participants in the
b) Cohort study establishes temporal association coffee consumption group developed pancreatitis,
c) Cohort has lower level of evidence than case-control whereas among the non-coffee consumption group 130
d) Do case control for rare exposures and cohort for in developed pancreatitis. Calculate the relative risk of

pancreatitis due to coffee consumption. disease and their matched sibling controls. The
a) 0.04 researcher collected history of exclusive breastfeeding
b) 0.85 (EBF) from the mothers. Presence/ absence of EBF was
c) 1.21 compared between the diseased and the non-diseased
d) 1.50 children. Identify the study design in this research?
a) Case series
25. All the following are elements of a cohort study, b) Cross-sectional study
EXCEPT- c) Case control study
a) It involves calculation of incidence rate d) Cohort study
b) It proceeds from exposure to outcome
c) It involves randomization of participants 29. Which of the following is INCORRECT about selection
d) It involves follow-up of the participants of cases in case control study?
a) Cases are study participants who had the disease in
26. All the following are limitations of a case control study, the source population
EXCEPT- b) Selection of cases should be based on the
a) It can introduce recall bias exposure status
b) Incidence of disease cannot be determined c) Inclusion of prevalent cases can save time and
c) Selection of appropriate control group may be money
difficult d) Inclusion of prevalent cases may introduce survivor
d) It can introduce attrition bias bias
27. Using medical records from a tertiary care cancer 30. A multicentric study was conducted to determine the
hospital, a researcher collected data on occupational association between diabetes and cataract. The
exposure and lung carcinoma on patients admitted investigators recruited 1000 diabetics and 2500 non-
between 2000 and 2010. He classified the patients who diabetics. The participants were examined to exclude
had history of working in coal mines as exposed and presence of cataract at the time of recruitment. They
others as unexposed. He then compared the frequency were followed once yearly for 10 years to document the
of lung carcinoma among the exposed and the development of cataract. The study found that the
unexposed. What best describes the study design? incidence of cataract among diabetics was more when
a) Case control study compared with the non-diabetics. Identify the study
b) Retrospective cohort study design in this study?
c) Cross-sectional study a) Cross-sectional study
d) Analytical cross-sectional study b) Case control study
c) Prospective cohort study
28. A paediatrician recruited 120 children with Crohn’s d) Experimental study

Lecture 7: Experimental study designs: Clinical trials

1. One of the cornerstones of the randomized controlled 8. What is the purpose of randomization in a clinical
trials is trial?
a) Recruitment a) Get better power for data analysis
b) Randomization b) Generalizing the study findings to the population
c) Blinding which is not studied
d) Placebo c) Achieve balance in baseline characteristics
d) Guarantee that the statistical tests have valid
2. Randomized clinical trials can be best described as significance levels
a) Experimental studies
b) Analytic studies 9. Which phase of a clinical trial is referred to as post-
c) Descriptive studies marketing surveillance?
d) Observational studies a) Phase 1
b) Phase 2
3. Which of the following is/are true in a clinical trial? c) Phase 3
a) Sample size determination d) Phase 4
b) Approval from regulatory authority
c) Agreement between the investigators and sponsors 10. Long-term adverse effects and efficacy of a new drug
d) All of the above can be tested in which of the following phases of a
clinical trial?
4. A pharmacologically inactive agent that investigators a) Phase 1
administer to participants in the control group of a b) Phase 2
trial c) Phase 3
a) Comparator drug d) Phase 4
b) Placebo
c) Conjugate 11. Which of the following is incorrect in case of a clinical
d) Drug under investigation trial?
a) All clinical trials must be blinded
5. Key methodological components of a Randomized b) Randomization is a critically important step in a
Controlled Trials are clinical trial
a) Use of a control to which the experimental c) All clinical trials must be approved by Institutional
intervention is compared Ethics Committee before initiation
b) Random assignment of participants to intervention d) It is mandatory to register clinical trials with Clinical
Trials Registry of India
c) Taking informed consent from all study participants
d) All of the above
12. Which of the following procedures ensure safety of the
clinical trial participants?
6. Double-blinding in a clinical trial involves
a) Adverse events reporting
a) Participants before and after study
b) Serious adverse events reporting
b) Participants and investigators c) Periodic follow-up
c) Investigators and analysts d) Review by Data Safety Monitoring Board
d) Participants and analysis e) 'a', 'b', 'c', and 'd'
f) 'a', 'b' and 'd'
7. The purpose of a double-blinding in a clinical trial is to
a) Achieve comparability of all arms of a clinical trial 13. All the following correctly describe a clinical trial,
b) Avoid observer and participant bias EXCEPT-
c) Avoid observer bias and sampling variation a) It has all advantages of a cohort study
d) Avoid subject bias and sampling variation b) It is possible to analyse the confounders

c) Loss to follow up of study participants does not control trial?
affect the study outcome a) Baseline characteristics of intervention and control
d) Appropriate implemented informed consent groups must be similar
procedure as well as long-term care and support to b) Investigator bias can be minimized by double
trial participants help to overcome several ethical blinding
concerns c) The sample size depends on the hypothesis being
tested
14. Which of the following can be considered as an d) Drop outs should be excluded from the analysis
advantage of a double blinding in a randomized
controlled trial? 21. State whether true or false. In a randomized controlled
a) Equally distributes known and unknown trial, the investigator is unaware of the sequence of
confounders in experiment and control arm allocation of the participants to one of the study arms
b) Ensures that participants adhere to the protocol before and until the assignment is complete. This
c) Gives benefits of an intervention to some of the study process is known as allocation concealment.
participants a) True
d) Prevent bias that arises from researchers being b) False
able to influence the data due to knowledge of
allocated groups 22. Which of the following is NOT a feature of randomized
controlled trials?
15. Biased outcome ascertainment results from: a) Simple random sampling
a) Participants reporting symptoms or outcomes b) Randomization
differently c) Allocation concealment
b) Investigators eliciting symptoms or outcomes d) Blinding
following a standardized technique
c) None of the above 23. A research group from a medical college in Lucknow
d) Both "a" and "b" conducted a study to assess the efficacy of a new herbal
medicine for the prevention of pneumonia in elderly.
16. In a clinical trial, what is the main purpose of What type of randomized controlled trial is this study?
randomization? a) Screening RCT
a) To get more power for data analysis b) Diagnostic RCT
b) To reduce investigator bias c) Therapeutic RCT
c) To get groups with comparable baseline d) Prophylactic RCT
characteristics
d) To ensure optimum number of participants in each 24. In which type of population is a phase-I vaccine trial
trial arm conducted?
a) Healthy volunteers
17. Which of the following can eliminate the problem of Co- b) High risk group
intervention? c) Diseased population
a) Random sampling d) Laboratory animals
b) Allocation concealment
c) Informed consent 25. State whether true or false. Randomization is a process,
d) Blinding where the participants have an equal chance of being
assigned to any one of the study groups.
18. Which of the following is not true in case of a clinical a) True
trial? b) False
a) Clinical trials are planned experiments designed to
assess the efficacy of an intervention 26. Which of the following is NOT an advantage of
b) Clinical trials usually involve comparing the randomized controlled trials?
outcomes in two or more groups of individuals a) Provides high quality evidence
c) Clinical trials are usually free from selection bias b) Controls for selection and confounding bias
d) Clinical trials are usually prospective in nature c) Establishes temporality of association
d) Entails minimal ethical issues
19. Which of the following trials assesses effectiveness of a
new vaccine? 27. Post-marketing surveillance is done in which of the
a) Phase 1 trial done in healthy volunteers clinical trial phases?
b) Phase 2 trial done in a susceptible population a) Phase 1
c) Phase 3 trial done in healthy volunteers b) Phase 2
d) Phase 3 trial done in a susceptible population c) Phase 3
d) Phase 4
20. Which of the following is not true about a randomized

28. State whether true or false. Randomized controlled b) Single blind RCT
trials are retrospective in nature. c) Double blind RCT
a) True d) Triple blind RCT
b) False
30. Blinding in a randomized controlled trial addresses
29. In a clinical trial conducted by the Orthopaedic which of the following biases?
department of a medical college in Bhubaneshwar, the a) Ascertainment bias
investigators compared the wound healing time b) Recall bias
between conventional suturing technique and stapling c) Volunteer bias
technique for open fractures. The investigators, d) Attrition bias
patients and data analysts were aware about the
treatment assignment. What best describes this study
design?
a) Open-label RCT

Lecture 8: Validity of epidemiological studies

1. Obtaining an estimate that is generalizable to relevant 6. All are true regarding measures to reduce information
study population in a research study is bias, EXCEPT
a) External validity a) Precise operational definitions of all variables
b) Internal validity b) Detailed measurement protocols
c) Bias c) Adequate sample size
d) Confounding d) Training, Certification and re-certification of data
collectors
2. Any process that tends to produce results that depart
systematically from true values in a research study 7. Variability in estimation due to
a) Chance unknown/uncontrollable factors
b) Bias a) Chance
c) Random error b) Bias
d) Effect Modification c) Confounding
d) Effect modification
3. Systematic selection of more number of exposed
participants with the higher risk of outcome in a cohort 8. All are true regarding confounding in an
study will result in epidemiological study, EXCEPT
a) Selection bias a) May simulate an association that does not exist
b) Information bias b) May increase or decrease the strength of association
c) Confounding c) May not reveal an association that does exist
d) Random error d) Always change the direction of effect
4. The effect of the exposure of interest on the outcome is 9. The method which can used to alleviate confounding
distorted because of the effect of extraneous factors during data analysis in an epidemiological study
that are related to both the exposure and outcome. This a) Multivariate analysis
phenomenon is called b) Restriction
a) Correlation effect c) Matching
b) Confounding d) Randomization
c) Recall bias
10. To reduce selection bias in case-control studies, all of
d) Measurement error
the following are true EXCEPT
a) Use population based design
5. Biases can occur during which stage of research study?
b) Apply different eligibility criteria for selecting
a) Study design
cases and controls
b) Study implementation
c) Both cases and controls undergo the same diagnostic
c) Data analysis
procedures
d) At any of the above stages
d) Avoid hospital based design

11. Obtaining an accurate estimate of disease frequency c) Stratification
and effect of exposure on health outcomes in study d) Adjusted analysis
population pertains to
a) External Validity 19. Systematic distortion of the truth by study subjects is
b) Internal Validity called as
c) Bias a) Plagiarism
d) Confounding b) Chance
c) Confounding
12. Blinding in an epidemiological study is a way to deal d) Prevarication
with
a) Chance 20. Crude association in the presence of a confounder is the
b) Selection Bias actual causal association
c) Information Bias a) True
d) Sampling Error b) False
13. Better recall of exposure only among the cases in a case 21. Which of the following is the best method of ensuring
control study can result in that the experimental and control arms in an
a) Information bias experimental study are similar with regard to known
b) Confounding and unknown confounders at the planning stage?
c) Investigator bias a) Matching
d) Selection bias b) Randomization
c) Stratification
14. The ability of a tool to correctly measure what it is d) Multivariate analysis
supposed to measure is called as
a) Precision 22. When the study finding is generalizable to the target
b) Validity population, then it is-
c) Reliability a) Internally valid
d) Consistency b) Reliable
c) Accurate
15. Bias may distort the association between exposure and d) Externally valid
outcome among the study participants
a) True 23. Which of the following can introduce selection bias in a
b) False case control study?
a) Differential recall about exposure by the cases
16. A case control study was conducted to know the effect b) Collecting data differently from the exposed and
of smoking on lung cancer among hospitalized patients. unexposed
The controls were recruited from patients admitted to c) Inclusion of controls not representative of the
the respiratory ward for other conditions. What type of target population
bias will be introduced by virtue of recruiting controls d) Systematic distortion of the truth by the study
from the hospital who are potentially different from the participants
general population?
a) Selection bias 24. Which of the following is TRUE about information bias
b) Information bias in a cohort study?
c) Confounding a) It is caused by higher attrition rate among the
d) Random error exposed group
b) It can be caused by selecting controls from the
17. A researcher studied the effect of coffee drinking on community
Myocardial Infarction. The effect of coffee drinking on c) It can be avoided by uniform outcome
Myocardial Infarction was distorted because of the ascertainment
presence of a third factor, i.e. smoking. This d) It can be minimised by reducing loss to follow-up
phenomenon is called as
a) Correlation effect 25. Which of the following is NOT a systematic error in an
b) Confounding epidemiological study?
c) Recall bias a) Random error
d) Measurement error b) Confounding
c) Selection bias
18. Which of the following method is used to address for d) Information bias
known confounders at the designing stage of a study?
a) Matching 26. Which of the following measure is related to ensuring
b) Regression the internal validity of a study?

a) Using a validated study questionnaire to assess c) Selection bias
outcomes d) Random error
b) Including an adequate number of study participants
c) Complying strictly with the study protocol 29. Which of the following is NOT a method of dealing with
d) All the above confounding during the design stage?
a) Restriction
27. Which of the following is FALSE about confounding in b) Stratification
epidemiological studies? c) Matching
a) Confounding may simulate an association when it d) Randomization
does not exist
b) Confounding does not increase or decrease the 30. A cohort study was conducted to examine the
strength of the association association between obesity and cardiovascular
c) Confounding may hide an association that exists disease. During analysis, gender was suspected to be a
d) Confounding may change the direction of an confounder. Which of the following methods will help
exposure-outcome association in examining the confounding effect due to gender?
a) Matching
28. Systematic collection of data by an investigator b) Restriction
supporting an expected conclusion in an c) Randomisation
epidemiological study may result in- d) Multivariate regression
a) Confounding
b) Information bias

Lecture 9: Qualitative research methods: An overview

1. Which methods in qualitative research use flexible 9. All the statements regarding Participant Observation is
interview guide? true EXCEPT
a) In depth Interviews and participant observation a) Observer becomes a part of the event/group
b) Focus Group Discussions and In-depth b) Systematic collection of data is easy
interviews c) Analytic methods for observation are not well
c) Participant Observation and focus group described
discussions d) Data is very detailed
d) Structure interviews and surveys
10. The qualitative data analysis method which uses
2. Which of the following study designs can be used as a theoretical framework as the basis for analysis
tool a generate ideas/hypotheses? a) Content analysis
a) Qualitative study b) Grounded theory
b) Case-control study c) Schema Analysis
c) Experimental study d) Hermeneutics
d) Cohort study
11. Which of the following are characteristics of qualitative
3. The qualitative data analysis method in which
research methods?
investigators code text into categories and build
a) Objective, measurable, reliable and repeatable
theoretical models
b) Subjective, measurable, credible and repeatable
a) Content analysis
c) Subjective, credible, inductive and
b) Grounded theory interpretation of responses
c) Schema analysis d) Objective, credible, inductive and interpretation of
d) Hermeneutics responses
4. Open-ended, one-to-one interviews to discover 12. The research method which is best suited for collection
interviewee's own framework of meanings of information regarding highly sensitive matters such
a) In-depth Interviews as alcohol use
b) Focus Group Discussions a) Focus Group Discussions
c) Participant observation b) Participant Observation
d) Structured interviews c) In-Depth Interview
d) Group discussions
5. Audio recordings during Focus Group Discussions
a) Can be done without any prior informed written 13. Which of the following is not the utility of qualitative
consent research?
b) Cannot be done a) To provide insight to why people behave in a certain
c) Should always be done way
d) Can be done with prior informed consent b) To estimate the prevalence of disease
c) To help understand the results of a quantitative
study
6. All of the following are situations in which qualitative
d) For developing a questionnaire
research methods can be used, EXCEPT
a) Familiar and sufficiently researched matter
14. Which of the following statement is true regarding
b) To seek the depth of understanding
Participant Observation
c) Exploration of behaviors a) Observer becomes a part of the event/group
d) View the social phenomenon holistically b) Systematic collection of data is easy
c) Analytic methods for observation are well described
7. The main methods used in qualitative research method d) Data is brief as compared to in-depth interviews
include all EXCEPT
a) In-depth Interviews 15. Open ended group interviews that promotes
b) Focus Group Discussions discussion among participants is called as
c) Participant observation a) In depth Interviews
d) Structured questionnaire-based interviews b) Focus Group Discussions
c) Participant Observation
8. The observer becomes a part of the group or event in d) Structured interviews
this method of qualitative study
a) In-depth Interviews 16. A researcher decided to conduct a study to explore the
b) Focus Group Discussions child feeding practices among mothers of under five
c) Participant observation children in a community. Which of the following
d) Structured interviews qualitative techniques can the researcher employ to
gather wide range of information on the topic in a short

span of time? approaches can be employed in this scenario?
a) Structured interview a) Qualitative study
b) In depth Interview b) Clinical trial
c) Participant Observation c) Mixed-methods study
d) Focus Group Discussion d) Cross-sectional study
17. In qualitative research, researchers interpret the social 24. Which of the following is NOT a data collection method
reality from the participants’ point of view. used in qualitative research?
a) True a) Interviews
b) False b) Sociogram
c) Participant observation
18. Which of the following statements is “Incorrect” about d) Focus group discussion
in-depth interviews?
a) Findings are always generalizable 25. Which of the following is NOT a feature of ‘In-depth
b) The transcripts are time consuming to analyze interviews’?
c) Helps understand sensitive issues a) It involves two or more participants at a time
d) Useful when participants are knowledgeable on a b) It follows an interview guide
particular topic c) It is suitable for a highly sensitive topic
d) It obtains rich contextualized information
19. Which of the following statement is “False” about focus
group discussion. 26. Which of the following is an advantage of conducting
a) Focus group discussions help understand local ‘in-depth interviews’?
terminologies a) It expresses the ‘Emic’ perspective
b) Group interaction is integral for an effective b) It is generalizable
discussion c) It is a quick process
c) Heterogeneity of the group is a pre-requisite d) It uses a systematic sampling approach
d) Audio and video recordings are done with prior
consent 27. State whether true or false. In a focus group discussion,
it is easy to obtain personal behaviours on a sensitive
20. Triangulation is the use of multiple methods, multiple issue
theories and or multiple sources for a comprehensive a) True
understanding of the topic in question b) False
a) True
b) False 28. Which of the following is TRUE regarding ‘participant
observation’ method?
21. Which of the following characteristics is NOT related to a) It is easy to analyze the data
qualitative research data? b) The researcher himself becomes a part of the
a) Subjective validity study group
b) Data is in text form c) Data obtained is very concise
c) Hypothesis testing is a goal d) The researcher interviews each participant in detail
d) It involves interpretation of responses
29. State whether true or false. Data obtained from Focus
22. Which of the following CANNOT be done using Group Discussion may be sensitive to biased analysis.
qualitative research? a) True
a) Viewing a social phenomenon holistically b) False
b) Estimating the burden of a disease
c) Seeking in-depth understanding of a phenomenon 30. The analytical approach where the researcher
d) Unfamiliar subject matter proceeds to develop a theory based on learnings
obtained from the data is called-
23. A researcher wants to estimate the prevalence of a) Grounded theory analysis
exclusive breast feeding in a remote tribal population. b) Content analysis
She also wants to understand the myths and taboos c) Schema analysis
associated with breast feeding. Which of the following d) Factor analysis

Lecture 10: Measurement of study variables

1. In a study on hypertension, patients are categorized b) 4.5
based on their systolic blood pressure as normal, pre- c) 9
hypertension, stage 1 hypertension and stage 2 d) 8
hypertension. What type of variable is this?
a) Qualitative 10. Difference between the minimum value and the
b) Descriptive maximum value of the observations
c) Nominal a) Variance
d) Ordinal b) Inter-quartile range
c) Range
2. Most commonly used measure of central tendency is d) Standard Deviation
a) Mode
b) Median 11. All the following are measures of dispersion EXCEPT
c) Mean a) Mean
d) Range b) Variance
c) Standard deviation
3. First quartile (Q1) is equivalent to __________ percentile d) Range
a) 25th
b) 50th 12. Which percentile is equivalent to the median?
c) 75th a) 25th
b) 50th
d) 1st
c) 75th
d) 100th
4. Find the median in the following sample of
observations: 12, 26, 10, 29, 48
13. All the following are true for standard deviation (SD)
a) 29
EXCEPT
b) 48 a) It is the square root of the average of the squared
c) 26 deviations of the observations from the arithmetic
d) 25 mean
b) It is the most important measure of dispersion
5. The following measure is not influenced by extreme c) It is expressed in the same units of measurement as
values in a data set the observation
a) Arithmetic Mean d) The square of the standard deviation is called
b) Inter-quartile range mean deviation
c) Range
d) 'b' and 'c' 14. A researcher measures fasting blood level of glucose of
100 participants. The mean blood sugar level was
6. Which of the following statistic does not belong with measured as 110 mg/dl. The standard deviation was 11
the others? mg/dl. Calculate the coefficient of variance.
a) Range a) 20%
b) Variance b) 14%
c) Mode c) 10%
d) Standard deviation d) 25%
15. A researcher measures the height of 100 school going

7. 'Number of children per household' is an example of a
children for his study. What type of variable is ‘height’?
continuous variable
a) Nominal
a) True
b) Ordinal
b) False
c) Continuous
d) Discrete
8. In a study, researchers are interested in measuring the
cholesterol levels of participants. Cholesterol level is a 16. A chest physician observed the distribution of forced
________ variable expiratory volume (FEV1) in 100 Chronic Obstructive
a) Ordinal Pulmonary disease (COPD) patients and calculated a
b) Nominal median value of 2.0 litres. The value of first and third
c) Continuous quartile of the distribution was 1.5 litres and 3.0 litres
d) Discrete respectively. Based on this data how many patients in
the sample are expected to have a FEV1 between 1.5
9. In the following set of data, what is the mean? and 3.0 litres?
4,1,9,7,3,8,2,6 a) 100
a) 5 b) 50

c) 25 students in a quiz:
d) 75 (5, 3, 6, 8, 7, 8, 3, 11, 6, 3) What is the median score of
this group?
17. The average of the absolute deviations of the a) 3
observations from the arithmetic mean is known as b) 6
a) Variance c) 8
b) Inter-quartile range d) 11
c) Mean deviation
d) Standard deviation 25. ‘Height of the students in a particular class measured in
centimetre’ is an example of a continuous variable
18. In a study, a researcher was interested in measuring a) True
the haemoglobin levels of 10 participants. The values b) False
are 10.0, 8.5, 12.0, 14.0, 11.5, 13.5, 9.0, 12.0, 11.3, 7.5.
What is the mode of this distribution? 26. What is the appropriate measure of dispersion to
a) 7.5 report when median is reported as the measure of
b) 12.0 central tendency for a given set of data?
c) 10.9 a) Standard deviation
d) 14.0 b) Inter-quartile range
c) Variance
19. All the following are examples of a nominal variable d) Coefficient of variance
EXCEPT
a) Gender 27. In the NCD clinic of a primary health centre, fasting
b) Age blood sugar (in g/dL) of 11 patients was measured. The
c) Place of residence following values were obtained - (85, 93, 104, 108, 105,
d) Colour of eyes 120, 129, 202, 160, 400, 410). What is the most
appropriate measure of central tendency for this data?
20. Which of the following is true about inter-quartile a) Mean = 120
range? b) Median = 120
a) It describes the middle value of the distribution c) Mean = 174.1
b) It divides the distribution into two halves d) Median = 174.1
c) It covers the middle 50% of observations
d) It is affected by the extreme values in the 28. Which of the following about ‘Range’ is TRUE?
distribution a) It indicates the way in which values cluster about a
particular point
21. When the data set contains too many extreme values, b) It gives the number of observations bearing the
the most representative average value is- same value
a) Mean c) It is the difference between the minimum and
b) Mode maximum value
c) Median d) It shows the degree to which the mean value differs
d) Variance from its expected value.
22. The age of ten pregnant women who visited an ANC 29. In a survey, socio-economic status (SES) was collected
clinic is given. What is the mean age of this group? in the following manner – ‘Lower, Lower Middle, Upper
(26, 31, 25, 26, 30, 27, 25, 32, 25 and 33 years). Middle and Upper’. What type of variable is SES?
a) 45 a) Ordinal
b) 28 b) Nominal
c) 25 c) Continuous
d) 32 d) Discrete
23. Which of the following is a relative measure of 30. Body weights of 11 children who attended a paediatric
dispersion when comparing variables which are OPD was measured. For this group, the first quartile,
measured in different units? median, mean and third quartile were 8.5, 12, 11.9 and
a) Inter-quartile range 16, respectively. Calculate the Interquartile Range.
b) Coefficient of variation a) 3.5
c) Range b) 7.5
d) Standard deviation c) 0.1
d) 24.5
24. The following scores were obtained by ten medical

Lecture 11: Sampling methods

1. The process by which some members of a population 4. The following statement is correct regarding sampling
are selected as representative of the entire population error
is known as a) Sampling error is difficult to measure in simple
a) Census random sampling
b) Sampling b) Sampling error is easy to measure in stratified
c) Survey sampling
d) Randomization c) The magnitude of error can be measured in non-
probability samples
2. Sampling based upon equal chance of selection is d) The magnitude of error can be measured in
called probability samples
a) Stratified random sampling
b) Simple random sampling 5. The only sampling method allows to draw valid
c) Systematic sampling conclusions about the population is
d) Subjective sampling a) Non-probability sampling
b) Convenience sampling
3. A researcher wishing to draw a sample from c) Probability sampling
sequentially numbered houses uses a random starting d) Subjective sampling
point and then selects every 6th houses, s/he has thus
drawn a ________ sample 6. All the following are true regarding cluster sampling
a) Sequential EXCEPT
b) Systematic a) It needs a complete list of units
c) Simple random b) The sampling unit is group of subjects
d) Stratified c) Sampling error is difficult to measure
d) Resources required are less

7. Methods used in probability samples are d) It allows inclusion of representative participants
a) Stratified sampling from all subgroups
b) Multi-stage sampling
c) Cluster sampling 15. Which of the following is true about non-probability
d) All of the above sampling?
a) It removes the possibility of bias in selection of
8. All the following statements are true regarding simple participants
random sampling EXCEPT b) Sampling error can be measured
a) Sampling error is easily measurable c) Quota sampling is a type of non-probability
sampling
b) It needs a complete list of all units
d) Inferences drawn from non-probability sampling
c) It ensures equal chance of selection for each unit
can be generalized
d) It always achieves best representativeness
16. Random sampling in probability samples reduces the
9. People who volunteer or who can be easily recruited
possibility of selection bias
are used in a sampling method called
a) True
a) Cluster sampling b) False
b) Multi-stage sampling
c) Convenience sampling 17. Which of the following statement is true regarding
d) Systematic sampling systematic random sampling?
a) Sampling error cannot be measured
10. Based on the number of cigarettes per day, a researcher b) The chance of selection for each sampling unit is
divides the population into three risk groups for lung unknown
cancer (low, moderate, high risk). If the researcher c) The selected sampling units are likely to be more
then draws a random sample from each of these risk representative than simple random sampling
groups independently, s/he has created a _________ d) It is a type of non-probability sampling
sample
a) Systematic 18. A researcher planned a cross-sectional study to assess
b) Simple random the level of satisfaction of patients attending a clinic.
c) Stratified For this, the researcher selected the first 100 patients
d) Group data who visited the clinic starting from a fixed date. What
is the type of the sampling mentioned in this case?
11. All the following are non-probability sampling a) Snowball sampling
methods EXCEPT b) Purposive sampling
a) Convenience sampling c) Simple random sampling
b) Snowball sampling d) Stratified random sampling
c) Quota sampling
d) Systematic sampling 19. The list of all individuals in the study population from
whom study participants in a research are to be
12. In a study to measure the prevalence of fluorosis in a selected is known as
district, towns are sampled first. This is followed by a a) Sampling frame
sample of wards within the selected towns, and finally b) Study population
a sample of households within the selected wards. c) Sampling unit
What is the type of the sampling used here? d) Study sample
a) Multistage sampling
b) Systematic random sampling 20. Which of the following is an advantage of multistage
c) Simple random sampling sampling?
d) Convenience sampling a) Sampling error is easy to measure
b) It does not require a complete list of the total
13. The magnitude of sampling error can be measured in population
probability sampling. c) It requires only one sampling list
a) True d) It always achieves the best representative sample
b) False
21. Which of the following sampling method ensures that
14. All the following statements are true regarding valid conclusions can be drawn about different
stratified sampling EXCEPT subgroups in a population?
a) It classifies population into homogeneous subgroups a) Simple random sample
b) The probability of a participant being selected is b) Systematic random sample
unknown c) Stratified random sample
c) The sampling error is difficult to measure d) Cluster random sample

d) 0.01
22. Which of the following about simple random sampling
method is FALSE? 27. Which one of the following statements about cluster
a) It needs a complete list of the units in the target sampling is FALSE?
population a) Units within a cluster are heterogenous
b) Purposive sampling is a type of simple random b) Sampling frame of the entire study area is not
sample required
c) It draws units from the target population randomly c) Variability between clusters is assumed to be
d) It gives equal chance of selection to every unit in the high
target population d) Sampling error is difficult to measure
23. Sampling achieves 28. Which one of the following statements about
a) Efficient utilization of resources multistage sampling is TRUE?
b) Elimination of random error a) It saves resources as compared to simple
c) Low non-response rate random sampling
d) Complete enumeration of population b) It requires a complete listing of the entire
population
24. In simple random sampling, the probability of selection c) It’s sampling error can be easily measured
of each individual is- d) It is not suitable for sampling from a large
a) Unequal population
b) Equal
c) Unknown 29. Which one of the following about stratified random
d) One sampling is FALSE?
a) Units within a strata are homogenous
25. Which one of the following biases is prevented by an b) Sample is taken from every strata
appropriate sampling technique? c) Precision improves with low numbers sampled
a) Volunteer bias in each stratum
b) Interviewer’s bias d) Stratum specific estimates are weighted to obtain
c) Social desirability bias the overall estimate
d) Recall bias
30. State whether True or False: Commonly used statistical
26. In a neighborhood with 5000 houses, a researcher inferences have the assumption of a probability
wants to obtain a systematic random sample of 50 sample.
houses. What will be the sampling interval in this case? a) True
a) 1000 b) False
b) 100
c) 0.1

Lecture 12: Calculating sample size and power

1. Statistical power is defined as the probability of 5. Population variance can be estimated from
a) Accepting a null hypothesis when it is false a) A pilot study
b) Rejecting a null hypothesis when it is true b) Reports of previous studies
c) Rejecting a null hypothesis when it is false c) Guessing
d) Failing to reject a null hypothesis when it is false d) 'a' and 'b'
2. Steps in the estimation of sample size included all of the 6. The recommended minimum level of power for an
following EXCEPT analytical study
a) Identify major study variable a) 5%
b) Decide on the desired precision of the estimate b) 95%
c) Adjust for population size c) 80%
d) Adjust for selection bias d) 0.05%
3. A type-II error occurs when 7. In general, sample size formula takes into account the
a) The null hypothesis is rejected when it is false crude association between exposure and outcome as
b) The null hypothesis is not rejected when it is well as the confounders
false a) True
c) The null hypothesis is not rejected when it is true b) False
d) The null hypothesis is rejected when it is true
8. Design effect of 'more than 1' needs to be considered in
4. Exact calculation of design effect for a study parameter studies involving
can take place you after study completion a) Cluster sampling
a) True b) Simple random sampling
b) False c) Stratified random sampling
d) Non-probability sampling

9. Which of the following is necessary in sample size c) Can be defined as the probability of correctly
determination? rejecting null hypothesis when it is false
a) Desired confidence level d) Represented as the probability of making a Type I
b) Desired precision error
c) Magnitude of the population variance
d) All of the above 18. The following are needed to calculate sample size for
analytical studies using simple random sampling
10. Which one of the following statements is false? method EXCEPT
a) Design effect is a relative change in the variance due a) Desired value for the probability of α
b) Magnitude of the expected effect based on previous
to use of clusters
studies
b) As the magnitude of the expected effect
c) Desired value for the probability of β
increases, the required sample size increases
d) Estimated design effect
c) The population variance is unknown in general and
has to be estimated
19. A researcher wants to estimate the prevalence of
d) Larger the sample size, smaller the sampling error surgical site infection following cesarean section at a
tertiary care hospital. What would be the minimum
11. A type-I error occurs when number of sample size to estimate the magnitude of
a) The null hypothesis is rejected when it is false surgical site infection following cesarean section if it is
b) The null hypothesis is not rejected when it is false estimated that the proportion of surgical site infection
c) The null hypothesis is not rejected when it is true will be 10% in the hospital considering 5% absolute
d) The null hypothesis is rejected when it is true precision and 95% confidence level (Z α/2 = 1.96).
a) 100
12. Which of the following is true about β error? b) 138
a) It is the probability of correctly rejecting the null c) 148
hypothesis when it is false d) 158
b) It is the probability of accepting the null
hypothesis when it is false 20. Precision is described as a measure of how close an
c) It is the probability of rejecting the null hypothesis estimate is to the true value of a population parameter.
when it is true a) True
d) It is the probability of making a Type I error b) False
13. All the following are essential statistical considerations 21. In a cross-sectional study, a group of researchers
for sample size calculation EXCEPT wanted to estimate the prevalence of cephalosporin-
a) Desired precision resistant E.coli among adult males with urinary tract
b) Anticipated proportion of factor of interest infections. From previous literature, the prevalence
c) Sampling method was found to be 6.5%. If the researchers want to
d) Allocated budget estimate the prevalence with a 20% relative precision
and 95% significance level, what is the minimum
14. For each confounder/variable added in the study sample size required?
empirically 10% increase in the sample size should be a) 1042
made. b) 1381
a) True c) 6
b) False d) 600
15. The design effect should be calculated after completion 22. Which of the following factors is NOT essential for
of the study and it, need not be counted at the design calculating sample size for a single mean estimation?
stage. a) Need for statistical significance
a) True b) Assumptions about population standard deviation
b) False c) Precision
d) Significance level
16. When estimating sample size for a cross-sectional
study, we need to account for 23. Adjustments to a calculated sample size need NOT be
a) Expected proportion of characteristic of interest done for which of the following reasons?
b) Estimated design effect, in case of cluster sampling a) Non-response rate
c) Population size b) Finite population size
d) All the above c) Cluster design
d) Hospital-based study
17. The power of a study
a) Does not influence the sample size 24. State whether true or false. A pilot study can be
b) Represented as ‘α’

conducted to get an estimate of the expected a) Precision
prevalence of the disease being studied to calculate the b) Power
minimum required sample size. c) Confidence
a) True d) Significance
b) False
28. Standard deviation of a sampling distribution is called
25. A cross-sectional study aims to estimate the prevalence systematic error
of Hydatid liver disease among patients undergoing a) True
Ultrasonography in a tertiary care hospital. Which of b) False
the following is NOT required for calculating the
minimum required sample size for this objective? 29. Design effect is considered for which of the following
a) Significance level sampling strategy?
b) Assumed prevalence a) Cluster sampling
c) Precision b) Simple random sampling
d) Population variance c) Stratified random sampling
d) Non-probability sampling
26. What is Type I error?
a) The probability of accepting the null hypothesis 30. In a hospital based cross-sectional study, it is planned
when it is false to estimate the mean D-dimer level among COVID-19
b) The probability of rejecting the null hypothesis patients. From previous literature, the standard
when it is true deviation was found to be 200 ng/mL. If the
c) The probability of rejecting the null hypothesis researchers want to estimate the mean with a 50
when it is false ng/mL precision and 95% significance level, what is
d) The probability of accepting the null hypothesis the minimum sample size required?
when it is true a) 62
b) 16
27. Ability of a study to detect correctly the presence of an c) 31
association is known as- d) 248

Lecture 13: Selection of study population

1. Selection of study participants depends on population
a) Representativeness d) The extent to which the characteristics of exposed
b) Acceptable cost population accurately reflect the characteristics of
c) Adequate size unexposed sample
d) All of the above
5. Non-response in a study can be minimized by
2. Target population is determined by a) Repeat contact of the study participants
a) Demographic characteristics b) Providing compensation for participants time
b) Temporal characteristics c) Less invasive and less sensitive questionnaires
c) Clinical characteristics d) All of the above
d) 'a' and 'c'
6. External validity means
3. Study sample is a subset of accessible population a) The degree to which the inferences drawn from
a) True a study can be generalized to a broader population
b) False beyond the study population
b) The degree to which the observed findings lead to
4. Representativeness of a study sample refers to correct inferences about phenomena taking place in
a) The extent to which the characteristics of the the study sample
sample accurately reflect the characteristics of the c) The degree to which a test actually measures what it
population is designed to measure
b) The size of the sample which is large enough d) The degree to which the findings are reliable
c) Volunteering nature of the subjects from the

7. Participants may be excluded from the study because b) External validity
of c) Feasibility
a) Interference with the success of study follow-up d) Accuracy
b) Ethical concerns
c) Interference with the quality of data collection or 15. Reasons for interference with the success of follow-up
non-acceptance to participate in the study in a study may include
d) All of the above a) Out-migration of some study participants from the
study area
8. While choosing the accessible population and the b) Marriage of some of the female study participants
because of which they might move out of the study area
sampling approach for selection of study population, an
c) Refusals for follow-up
important factor
d) All of the above
that we need to consider is
a) Simplicity
16. Less invasive and less sensitive questionnaires will
b) Technology
a) Increase the power
c) Feasibility b) Decrease the power
d) Reliability c) Improve the significance
d) Reduce the non-response
9. If your research question is related to diagnosis,
treatment or prognosis of a severe medical condition, 17. The external validity in a research study means
then it is an easy and a) The degree to which the observed findings lead to
cost-effective way to recruit the study population from correct inferences about phenomena taking place in
the community the study sample
a) True b) The degree to which a test actually measures what it
b) False is designed to measure
c) The degree to which the inferences drawn from
10. Reasons for interference with the success of follow-up a study can be generalized to a broader population
in a study may include beyond the study population
a) Migration of some study participants from the study d) The degree to which the findings are reliable
area
b) Marriage of some of the female study participants 18. The degree to which the observed findings lead to
because of which they might move out of the study correct inferences about phenomena of interest in the
study sample is
area
a) Reliability
c) Refusals for follow-up
b) Feasibility
d) All of the above
c) Internal validity
d) External validity
11. The population defined by clinical and demographic
characteristics is called
19. Which factor is important to consider while choosing
a) Target population
the accessible population and the sampling approach?
b) Accessible population
a) Feasibility
c) Subset
b) Sensitivity
d) Study sample
c) Specificity
d) Reliability
12. The population defined by geographical and temporal
characteristics is called as
20. The participants may be excluded from the study
a) Target population
because of
b) Accessible population
a) Interference with the success of study follow-up
c) Subset
b) Ethical concerns
d) Sample size
c) Interference with the quality of data collection
d) All of the above
13. Random errors can be effectively handled by
a) Randomisation
21. Which of the following helps to minimize the random
b) Representativeness
error in a research study?
c) Adequate sample size
a) Limited study duration
d) All of the above
b) Adequate sample size
c) Adequate budget
14. A researcher found an inference about a particular
d) More than six investigators
disease of interest. If he/she wants to generalize the
results, it is important to have
22. Representativeness of the study participants similar to
a) Internal validity

the population of interest can help in which of the to the target population
following aspects of a research study?
a) Generalizability of the findings 27. Which of the following statements on study
b) Internal validity populations is TRUE?
c) Reduce information bias a) Study sample is a subset of the accessible
d) Minimize recall bias population
b) Target population is a subset of the accessible
23. An investigator intends to estimate the prevalence of population
Urinary Tract Infection (UTI) among circumcised c) Accessible population is a subset of the study sample
children (<5 years old) in Jaipur city. However, the d) Target population is a subset of the study sample
researcher selects the study participants from one
government hospital. Which of the following is the 28. State whether true or false. Biases can affect both
target population in this study? internal and external validity.
a) All children aged <5 years in the city a) True
b) All circumcised children aged <5 years in the city b) False
c) All circumcised children aged <5 years attending the
government hospital 29. In a community-based vaccine trial, which aims to
d) All children having UTI in the city compare the 1-year incidence of intussusception in
children receiving/not receiving rotavirus vaccine,
24. Which of the following is the accessible population in which of the following can be a likely exclusion
the above study? criterion?
a) All children aged <5 years in the city a) Children who may leave the study area within a
b) All circumcised children aged <5 years in the city month
c) All circumcised children aged <5 years b) Children aged 0 months to 24 months
attending the government hospital c) Children without pre-existing intestinal anomalies
d) All children having UTI in the city d) Children who have not received rotavirus vaccine
previously
25. State whether true or false. High non-response rate in
a study may affect the internal validity. 30. In a cohort study planned to estimate the incidence of
a) True birth defects among Zika virus infected pregnant
b) False women in Chennai city, which of the following CANNOT
be an inclusion criterion?
26. Which of the following is TRUE about study validity? a) First trimester pregnant women with lab-confirmed
a) An internally valid study result is always Zika virus infection
generalizable to the target population b) Pregnant women who are permanent residents of
b) An internally valid study result may or may not Chennai city
be generalizable to the target population c) Pregnant women aged above 18 years
c) An externally valid study result is not generalizable d) Pregnant women taking drugs known to cause
to the target population birth defects
d) A study without internal validity can be generalized

Lecture 14: Study plan and project management

1. Which of the following statements regarding study c) Choose the right study design
objectives is correct? d) All of the above
a) Objectives should be defined at the planning
stage of study 3. Which of the following can improve efficiency of a
b) Objectives can be defined at any time of the study research study?
Objectives can be changed even at the end of the study a) Time management
d) Objectives should be defined before identifying the b) Planning and scheduling activities
research question c) Budgeting
d) All of the above
2. Which of the following is (are) required to determine
the key indicators for planned research study? 4. Which of the following represents the correct sequence
a) Frame study objectives in a life cycle of a study?
b) Identify parameters needed for the key indicators a) Identifying data needs, formulating study objectives,

planning analysis, spelling out research question a) Long and self-explanatory question using complex
b) Formulating study objectives, planning analysis, terms
spelling out research question, identifying data needs b) A question based on ill-defined hypothesis
c) Identifying data needs, spelling out research c) A question based on strong hunch on part of the
question, formulating study objectives, planning investigator
analysis d) A question based on established theory and
d) Formulating study objects, spelling out research some research evidence
question, identifying data needs, planning analysis
12. Which of the following can be considered true in case
of ad hoc approach to conduct a research study?
5. It should be ensured that products/deliverables of
a) Its advantages are the low development effort
health research projects are delivered within the
and possibility of getting results in a short time
a) Defined timeframe
span
b) Defined budget
b) Its advantage is that the accuracy of the results is
c) Expected quality standards
usually high
d) All of the above c) Only 'a'
d) Both 'a' and 'b'
6. Which of the following statements best describes the
study objectives? 13. A cross sectional study is carried out to examine
a) They should be minimum, achievable and clear whether naval medical personnel of a higher rank have
b) They can be primary and / or secondary more positive copying skills than those of a lower rank.
c) Adding objectives during study implementation is a Which of the following statement is true of this study?
good practice a) Neither variable is dependent as the researcher
d) 'a' and 'b' cannot manipulate them
b) The independent variable is rank and the
7. Principles to be followed while collecting the dependent variable is copying skills
information elements are c) The independent variable is copying skills and the
a) Use the variables that will best reflect the dependent variable is rank
information element d) None of the above
b) Adopt standardize case definitions and laboratory
criteria/normal ranges 14. Indicators are considered positive when they have a
c) Choose the most accurate ways of collecting direct relationship (association, correlation) with the
state of health. Which of the following are the examples
information on various elements
of positive indicators?
d) All of the above
a) The proportion of cured tuberculosis cases
b) Incidence of AIDS
8. Study conducted following an ad hoc approach may
c) Life expectancy at birth
lead to the following consequences
d) 'a' and 'c'
a) Generation of useful data in programs or for policy e) 'b' and 'd'
making f) 'a', 'b', 'c' and 'd'
b) Efficient utilization of resources
c) Serious difficulties in analysis and 15. Which of the following techniques is preferentially
interpretation used when the population is finite?
d) All of the above a) Purposive sampling technique
b) Area sampling technique
9. Common reasons for research study failures c) Systematic sampling technique
a) Poorly defined research question d) None of the above
b) Vague timelines
c) Lack of supervision 16. A study began in 1980 with enrollment of a group of
d) All of the above 7000 adults in Pondicherry who were asked about
their alcohol consumption, smoking, diet,
10. Sample size for a cross-sectional study is decided based environmental risk factors etc. All the participants
on the following were periodically examined and evaluated for evidence
a) Assumed/reported prevalence of various types of cancers between 1990-1995. Which
b) Confidence interval of the following study designs was used by the
investigators?
c) Acceptable precision
a) Case-control study
d) All of the above
b) Prospective cohort study
c) Ecological study
11. Which of the following is a criterion for a good research
d) Retrospective cohort study
question?

17. An increased number of postoperative wound in the life cycle of a study?
infections were recorded in patients who underwent i. Developing research question
incision appendectomy compared with those who had ii. Planning the data analysis
a laparoscopic procedure. Which of the following iii. Data collection
statement/s is/are true in such a scenario? iv. Data analysis
a) This association may simply be owing to the a) i, iii, iv, ii
presence of a confounding factor b) i, ii, iii, iv
b) Association between the two can be better studied c) i, iii, ii, iv
in randomized controlled clinical trials d) ii, iii, iv, i
c) Both 'a' and 'b'
d) None 24. Which of the following factor is NOT essential for
effective planning and management of a study?
18. In a study to evaluate the effectiveness of a new a) Time management
medication, which of the following will generate a b) Financial management
stronger evidence? c) Reduction of sample size
a) Comparing outcomes among those receiving d) Team work
medication with those not receiving the same.
b) Comparing outcomes among those receiving higher 25. Which of the following is to be followed while collecting
doses of medication with those receiving lower doses the information elements?
c) Comparing adverse events and drug reactions a) Use of variables that best reflect the information
among those receiving medication and those not element
receiving medication b) Standardized case definitions
d) All of the above c) Use of validated and standardised methods
d) All the above
19. Smart objectives are goals that are designed to be be
specific, measurable, achievable, relevant and time- 26. State whether true or false. Framing several study
bound. Which of the following is an illustration of non- objectives improves the study planning and
measurable objective? management
a) Incidence of colorectal cancers in Indian adult men a) True
b) Experiences shared by victims of domestic b) False
violence
c) To determine if regular skin emollients applied from 27. State whether true or false. Selection of study design
2 weeks of age reduced development of atopic should be related to the objectives.
dermatitis by age 12 months in the general infant a) True
population b) False
28. A postgraduate wants to do a community based thesis.
20. Validity of a research can be improved by: Which of the following is a part of the planning and
a) Taking the true representative sample of the program management of the study?
population a) Calculating sample size
b) Eliminating extraneous factors and collecting b) Arranging transport to community
detailed information on confounding factors c) Writing thesis
c) 'a' and 'b' d) All the above
d) None of these
29. Which of the following can be used to represent the
21. Which of the following is ideally the first step in duration, timeline and sequence of activities and
developing a study? milestones of a research project?
a) Fixing the title a) Bar chart
b) Formulating the research question b) Histogram
c) Writing the background c) Gantt chart
d) Planning for analysis d) Pie chart
22. Which of the following is a reason for the failure of a 30. Who is primarily responsible for resource allocation
study? and time management in a study?
a) Poorly stated research question a) Institute where the research is conducted
b) Unrealistic timeline b) Principal investigator
c) Inadequate supervision c) Funding agency
d) All the above d) Scientific committee
23. Which of the following represents the correct sequence

Lecture 15: Designing data collection tools

1. Which component of the data collection instrument is 5. The interviewer does not provide options for
constituted by open, closed and semi-open items? responses in
a) Introduction a) Open-ended questions
b) Identifier b) Close-ended questions
c) Questions c) Semi-open questions
d) Concluding statement d) All of the above
2. Self-administered questionnaire can be 6. What is the disadvantage of closed questions with

a) Paper-based or computer-assisted dichotomous options in a study questionnaire?
b) Used in face-to-face interviews a) Detailed information available
c) Used in telephonic interviews b) Oversimplifies the issues
d) All of the above c) Forces an unclear position
d) May not be useful for key well framed issues
3. While formulating the questions, all the following need
to be followed, EXCEPT 7. The information about participant's attitudes for
a) Short and clear questions behaviors such as wearing helmets, washing hands
b) Avoid ambiguities before eating, constitute
c) Avoid words of every-day language a) Facts
d) Avoid negatives and double negatives b) Knowledge
c) Judgments
4. Structured observation guide d) Texts
a) Is useful to document certain processes
b) Use checklist of items 8. The type of questions in which there is a possibility to
c) Can be used for in-depth interviews add other answer in addition to the options suggested
d) 'a' and 'b'

a) Open questions patients presented with foreign body in nose, attended
b) Semi-open questions in the emergency department in the last 2 years in a
c) Closed questions hospital. Which of the following is the most suitable
d) Close questions with multiple options way to collect data?
a) Review of records
9. The type of questions in a questionnaire which allow b) Cohort study
creation of continuous variables as responses c) Randomized trial
a) Closed questions with quantitative answers d) Focus group discussion
b) Open questions with quantitative answers
16. Order of a question should be all, EXCEPT-
c) Both of the above
a) From simple to complicated
b) From general to specific
c) From intimate to casual
10. All are true regarding the order of questions in a data
d) In chronological order
collection tool EXCEPT
a) From intimate to casual 17. Structured observation guide
b) From general to specific a) Is useful to document certain process
c) From simple to complicate b) Uses checklist of items
d) In chronological order, if questions related to c) Both 'a' and 'b'
sequence of events d) None of the above
11. A question was framed by an ophthalmologist as a part 18. Which of the following factors related to data collection
of data collection tool for her research- may lead to study failures?
“Which of the following symptoms you had in the last a) Poorly defined research question
one week?” The options were – (1) Eye pain; (2) b) Vague timelines
Redness of eye; (3) Watering of eye; (4) Low vision. c) Lack of supervision
Given that a study participant may have multiple d) All of the above
complaints, which of the following best describes the
type of question? 19. In which of the following type of question the
a) Open question interviewer does not provide options for responses?
b) Closed questions with dichotomous options a) Open-ended questions
c) Closed question with multiple options b) Close-ended questions
d) Closed question with quantitative answers c) Semi-open questions
d) Closed question with multiple options
12. A researcher has framed a question in the research tool
as- “What is the monthly income of the family?” This 20. 'Age in years' is commonly a continuous variable.
information constitutes- However, a resident doctor decided to ask age as a
a) Facts closed question with dichotomous options (If age>65
b) Knowledge years or <65 years). What is the disadvantage of such
c) Judgments type of ques in a study questionnaire?
d) Healthy Life styles a) Detailed information available
b) Oversimplifies the issues
13. Which of the following is correct in relation to an open b) Forces an unclear position
question? d) It is easy to convert a dichotomous variable to a
a) Answers are suggested continuous variable
b) Stimulate memory
c) Easy to code and analysis 21. Which one of the following is NOT a component of a
d) Freedom to respond is compromised data collection tool?
a) Informed consent
14. Glasgow coma Scale (GCS) is a scoring system to b) Concluding statements
understand the consciousness level of a person. The c) Identifiers
score varies between 3 and 15. A researcher has d) Tabulated results
included a question in research tool- “What is the GCS
score during admission?” 22. Which of the following is TRUE about a data abstraction
This question is an example of- form?
a) Open question a) It is used to collect data by going through records
b) Closed question with dichotomous option b) It is more valid than a questionnaire
c) Closed question with multiple option c) It can be self-administered by the participants
d) Closed question with quantitative answers d) It is also called an observational checklist
15. An investigator wanted to study the clinical profile of

23. Which of the following is FALSE about a questionnaire? c) Semi-open
a) It can contain instructions or prompts for data d) Open question with closed answers
collectors
b) It should contain unique participant identifiers 27. Which of the following is FALSE about formulating
c) It should avoid skip patterns questions in a study tool?
d) It can contain a mix of open and closed questions a) They must be concise and precise
b) They must use scientific terms
24. Identify the type of the question given below. c) They must use a neutral tone
“How do you spend your leisure time? _____________ d) They must avoid double negatives
(Write any two activities)”
a) Open ended 28. Which rule is NOT followed in the framing of the
b) Closed question given below?
c) Semi-open "When and where did you get tested for COVID-19
d) Open question with closed answers infection?"
a) Using a neutral tone
25. Which of the following is TRUE about ‘Open question b) Avoiding use of double negatives
with closed answers’? c) Asking a single question at a time
a) Its answers are not suggested to the participants d) Using simple words of everyday language
b) It can be used in a self-administered questionnaire
c) It is analyzed like an open ended question 29. State whether true or false. Before using a data
d) It is expressed as a closed question to the collection tool in the study, it will be useful to get it
participants reviewed by a statistician.
a) True
26. What is the type of the question given below? b) False
From where do you usually get health-related
information? 30. What is FALSE about pilot testing of a study
i. Television questionnaire?
ii. Radio a) It checks the tool for clarity and acceptability
iii. Newspaper b) It is conducted among persons who will be
iv. Magazine included in the study
v. Others (specify)________________ c) It provides an estimate of the duration of interview
a) Open ended d) Changes are made to the questionnaire based on its
b) Closed findings

Lecture 16: Principles of data collection

1. Reliability denotes to the field investigators
a) Precision a) True
b) Repeatability b) False
c) Reproducibility
d) All of the above 9. Which of the following statement is (are) true
regarding data collection for an epidemiological
2. This should not be done in data collection study?
a) Training of staff members a) Reliability refers to consistency of information
b) Review of collected data for quality and b) Accuracy is the ability of a measurement to be
completeness correct on an average
c) Manipulation of data c) Feasibility is the ability of investigator to understand
d) Validation the data
d) 'a' and 'b'
3. Supportive supervision is essential for a good data
collection process 10. Time pressure during data collection may result in
a) True dilution of data quality
b) False a) True
b) False
4. The collected data should be
a) Complete 11. A data collection tool should be _____________
b) Readable a) Valid
c) Consistent b) Reliable
d) All of the above c) Both 'a' and 'b'
d) None
5. Which of the following is (are) true about the training
of data collection staff? 12. A neurosurgeon is planning for a hospital-based study
a) Conduct on-site training on the patients coming to the emergency department
b) Conduct mock training sessions with head injury. The collected data should be
c) Training is always optional a) Complete
d) 'a' and 'b' b) Readable
c) Consistent
6. Which one of the following is the proper way of d) All of the above
validating the data?
a) Repetition of full data collection in the same 13. Which of the following should not be done in relation
population to data collection?
b) Data collection in new population a) Training of staff members
c) Repetition of data collection in a randomly b) Review of collected data for quality and
selected subset in the same population completeness
d) Repeat data collection is not required c) Validation
7. Appropriate means to troubleshoot the difficulties in
data collection process 14. State whether true or false: Piloting a data collection
a) Regular review meetings tool should be done under supervision
b) Facilitate the discussion to identify issues during the a) True
review b) False
c) Clarify the issues experienced by staff during data
collection 15. All of the following are true about a ‘question by
d) All of the above question guide’, except-
a) It is a document for the data collectors
8. There is no need to present the study and its objectives b) It helps in maintaining uniformity of the data

collection a) Accuracy
c) It helps participants on how to respond b) Repeatability
d) It clarifies doubts on data collection c) Precision
d) External validity
16. Time pressure during data collection may result in
dilution of the data quality 24. Which of the following should NOT be done during data
a) True collection in a study?
b) False a) Referring to the data collection guide
b) Checking the quality of data
17. Which one of the following is the proper way of c) Modifying the study objectives
validating the data? d) Validating the data collection process
a) Repetition of full data collection in the same
population 25. State whether true or false. Accuracy of an instrument
b) Data collection in a new population is the ability to measure what it intends to measure.
c) Repetition of data collection in a randomly a) True
selected subset in the same population b) False
d) Repeat data collection not required
26. Which of the following is the correct sequence of steps
18. Which of the following statement is true regarding data of data collection?
collection for an epidemiological study? i. Preparation of data collection guide
a) Reliability refers to consistency of information ii. Checking the collected data for completeness
b) Accuracy is the ability of a measurement to be iii. Training of the data collector
correct on an average iv. Validating the collected data
c) Both ‘a’ and ‘b’ a) i, iv, iii, ii
d) None of the above b) ii, iii, iv, i
c) i, iii, ii, iv
19. Who is mainly responsible to check the accuracy of data d) iii, i, iv, iii
collection instruments before leaving the location?
a) Field investigator 27. State whether true and false. A data collection
b) Field supervisor guidebook can be revised time to time as issues in the
c) Principle investigator data collection process are identified.
d) Study participant a) True
b) False
20. All the following statements are true about training of
the data collectors, except- 28. Which of the following should NOT be done during
a) Essential to ensure good quality data training of data collectors?
b) The investigators should choose the right people a) Simulating the data collection procedure
c) Communication skill is important for the data b) Discussing the study objectives with them
collectors c) Using an early version of the questionnaire for
d) Onsite training is not essential for data training
collectors d) Revising the question guide according to queries
21. The ability of an instrument to produce similar results 29. Which of the following does NOT apply in checking the
on repeated measurement is called- quality of filled forms during data collection?
a) Validity a) Completeness
b) Reliability b) Consistency
c) Accuracy c) Readability
d) Sensitivity d) Statistical significance
22. The mean value of fasting blood sugar among 50 30. During data collection in a study, a data collector is
healthy volunteers in a community was found to be 90 faced with a situation where the participant refuses to
g/dL with a standard deviation of 5 mg/dL using a new answer a particular question in the middle of the
diagnostic test. In the same volunteers, the gold interview. What is the appropriate action in this
standard test found a mean of 88 g/dL with standard situation?
deviation of 4.7 g/dL. What can be said about the new a) End the interview and report to the investigator
diagnostic test? b) Continue the interview with the remaining
a) The new diagnostic test is valid questions
b) The new diagnostic test is reliable c) Seek the answer to that question from family
c) The new diagnostic test is valid and reliable members
d) The new diagnostic test is invalid and unreliable d) Try to persuade the participant to answer the
question somehow
23. Which of the following is NOT used as a criterion to
judge the quality of data collected in a study?

Lecture 17: Data management

1. Steps in data management include 3. In a data management system, each row represents a
a) Defining a variable, creating a study database and a) Variable
dictionary b) Record
b) Enter data, correct errors and create data set for c) Heading
analysis d) Appendix
c) Backup and archive data set
d) All of the above 4. What is (are) the specifications that we need to check
before doing data entry?
2. When we are creating variable name, it should be a) Minimum and maximum values, legal codes, skip
a) Clearly understandable and should refer to the patterns
questionnaire b) Record name and description of record
b) Long and can have spaces c) Automatic coding, coping data from preceding
c) Consistent and without duplicates record and calculations
d) 'a' and 'c' d) 'a' and 'c'

5. Identifier in the database is (are) 13. A variable name should be-
a) Unique a) Clearly understandable and should refer to the
b) Maintained by a computerized index questionnaire
c) Secured by quality assurance procedures b) Short, no space
d) All of the above c) Consistent and without duplicates
d) All of the above
6. Key elements of data management
a) Data structure and data entry 14. Design of data entry can be broadly outlined as-
b) Individual and aggregated databases a) Identifier, Demographics, Outcome, and
c) Mother and daughter databases Exposure
d) All of the above b) Informed consent, Identifier, and Demographics
c) Identifier, Demographics, Outcome and data analysis
7. The design of data collection instrument plan
a) Data entry friendly d) Informed consent, Identifier, Demographics,
b) Outline of major data collection topics/items Outcome and data analysis plan
c) Auto coding function
d) All of the above 15. All of the following are true about ‘Coding’ a new
variable, EXCEPT-
8. When we are coding for data entry, we should a) Prefer numerical coding
a) Prefer numerical coding b) Decide on missing values while coding
b) Use highly complex codes c) Avoid cumbersome codes
c) Decide on the codes for 'missing values' and 'not d) coding with ‘0’ and ‘1’ should be avoided for
applicable' items dichotomous variables
d) 'a' and 'c'
16. Data entry can be considered as an opportunity to
9. When information is available at various levels (e.g. at partially clean the data
Village, Household, Individual and Illness episode), we a) True
b) False
can store information at each level in separate
databases and link when necessary
17. A researcher in diabetes expected that that the fasting
a) True
blood sugar levels may take any value between 50 and
b) False
150 gm/dL. In this research any coding of missing
value as 99 may lead to an erroneous result.
10. Which of the following is (are) not true about
a) True
normalized database?
b) False
a) Normalized database facilitates further aggregation
b) It has only one count by record
18. While documenting the storage information of the
c) Normalized database does not facilitate further
database, we need to document
data aggregation a) Investigators information
d) 'a' and 'b' b) Time, place, person information
c) Media, location and backup information
11. A post-graduate researcher has completed the data
d) Hardware configuration
collection for her thesis. During data management, she
should do all the following, EXCEPT-
19. Which of the following is incorrect in relation to the
a) Applying for the ethics committee clearance
data catalogue?
b) Create study database
a) It describes all the variable for any future reference
c) Create dataset for analysis
b) It is useful if we share the data with others
d) Back-up dataset
c) It is useful to know how a variable has been coded
12. Data documentation includes information about the d) It is advisable to exclude the missing values from
following items- data catalogue
a) Structure (Name, number of records etc) alone
b) Storage information (Media, location, backup 20. Which of the following is incorrect about normalized
information) database?
c) Structure (Name, number of records etc), a) Normalized database facilitates further aggregation
Variables (Name, values, coding), History b) It has only one count by record
(Creation, modification), and Storage information c) Normalized database does not facilitate further
(Media, location, backup information) data aggregation
d) Structure (Name, number of records etc), Storage d) Both ‘b’ and ‘c’
information (Media, location, backup information), and
Variables (Name, values, coding) 21. Which of the following is FALSE about Unique

Identifier (ID)? d) It links the variables in the database to the
a) It can be same for more than one participant in questionnaire
a study
b) It can be alphanumeric 27. Identify the type of variable in this question.
c) It can be a composite number “Have you ever smoked cigarettes?
d) It can be used to maintain the anonymity of 1. Yes
participants 2. No”
a) Categorical
22. Which of the following is NOT a quality assurance b) Ordinal
measure in designing a data entry form? c) Continuous
a) Using legal values d) Discrete
b) Using minimum and maximum values
c) Avoiding skip patterns 28. In a study on cancer, the ‘stage of cancer’ was recorded
d) Use of automatic coding as Stage I, Stage II, Stage III and Stage IV. Which of the
following variable types best describes the ‘stage of
23. In a data management system each column represents cancer’?
a(n)- a) Nominal
a) Variable b) Ordinal
b) Record c) Categorical
c) Heading d) Continuous
d) Appendix
29. In a study with 100 participants, age was recorded as a
24. Which of the following is FALSE about Mother- continuous variable. During data entry, it was seen that
Daughter databases? age was missing in the forms for 13 people. Which of
a) Information is collected at various levels the following is TRUE in this situation?
b) Information of each level is stored in a different a) Missing values can be coded as ‘999’
database b) Age variable should be removed from the study
c) They can be linked by a common index identifier c) An arbitrary value can be assigned by the data entry
d) Each database cannot have its own unique operator
identifier system d) Participants with missing age should be removed
from the study
25. State whether true or false. Coding with ‘0’ and ‘1’
should be avoided for dichotomous variables. 30. State whether true or false. While entering the systolic
a) True blood pressure (expected value 60 to 200) value in a
b) False database, coding the missing value as 99 may lead to an
erroneous result.
26. Which of the following is FALSE about data dictionary? a) True
a) It is created after the data entry is started b) False
b) It contains the values assigned to the variables
c) It gives a brief description of the variables

Lecture 18: Overview of data analysis

1. The three stages of data analysis are in the following b) Data drenching
order c) Stratified data analysis
a) Descriptive stage, analytical stage and recoding d) 'a' and 'b'
stage
b) Recoding stage, descriptive stage and analytical 3. In the descriptive stage of analysis, we use logistic
stage regression models
c) Analytical stage, descriptive stage and recoding a) True
stage b) False
d) Descriptive stage, coding stage, recoding stage
4. "Epi-Info" is a software used for data entry and data
2. We need to avoid the following while performing data analysis
analysis a) True
a) Post hoc analysis b) False

5. In analytical stage of data analysis, we perform the b) False
following in order
13. In a research study the analysis plan depends on
a) Stratified analysis, univariate analysis and
a) Objectives and study type
multivariate analysis
b) Allocated budget
b) Univariate analysis, stratified analysis and
c) Availability of the statistician
multivariate analysis
d) Existing time for analysis
c) Multivariate analysis, univariate analysis and
stratified analysis 14. At the time of data cleaning, which of the following is
d) Frequency analysis and univariate analysis not done?
a) Checking and removing duplicates
6. Among the seven steps of data analysis strategy, the b) Dealing with missing observations
sequence of data analysis is as follows c) Calculating strength of association
(A) Conduct advanced analysis d) Checking range and legal values
(B) Identify main variables
(C) Become familiar with the data 15. To describe the study population characteristics, we
(D) Identify study type need to
(E) Examine outcome/exposure association a) Calculate the frequency distribution
(F) Characterize study population b) Calculate measures of association
(G) Create additional two-way tables c) Look for correlation between variables
a) A, B, C, D, E, F, G d) perform multivariable regression
b) G, E, F, D, A, B, C
c) D, B, C, F, E, G, A 16. While examining the association between exposure
d) E, F, G, C, A, B, D and outcome based on a priori hypotheses, we compare
frequency of exposures between cases and controls
7. In case of descriptive studies, which of the following is using appropriate measure of association
wrong? a) True
a) We describe the study outcome for 1 group b) False
b) We compare the study outcome for 2 groups
c) We calculate the incidence for cohort or surveillance 17. If we are doing an analytical study and the study
data outcome is of acute nature and a frequent condition
d) We calculate prevalence for cross sectional survey what is the appropriate (i) study design and (ii)
measure of association?
8. If we are doing an analytical study and the study a) Cohort study - relative risk
outcome is of acute nature and rare condition what is b) Case-control study – odds ratio
the appropriate (i) study design and (ii) measure of c) Cross sectional study - Prevalence
association? d) Surveillance - Incidence
a) Cohort study - Relative risk
b) Case-control study - Odds ratio 18. Which of the following statements are CORRECT
c) Cross-sectional study - Prevalence ratio a) Plan for data analysis is made at the end of the study
b) Recoding can be done for key variables
d) Surveillance - Incidence
c) Multivariate analysis is done before doing a
9. Analysis plan depends on univariate analysis
a) Objectives of the study d) Data drenching is acceptable
b) Budget
c) Study type (Descriptive or analytical) 19. Which of the following is the correct sequence for data
analysis
d) 'a' and 'c'
i. Multivariate analysis
10. Use of spreadsheets, such as Excel, should be avoided ii. Recoding
for data management and analysis iii. Measures of association
a) True iv. Frequency distribution
b) False a) ii, iii, iv, i
b) i, iii, iv ii
11. Multivariate regression models are used during the c) ii, iv, iii, i
descriptive stage of analysis d) iii, iv, i, ii
a) True
b) False 20. Spreadsheets are ideal tools for data entry and analysis
a) True
12. “Epi-Info” is a software that can be used to create data b) False
collection instrument format
a) True

21. All the following are done to characterize the study b) Calculating frequency of the outcome by age and
population EXCEPT gender
a) Provide frequency distribution of age c) Calculating odds ratio between exposure and
b) Provide percentages of gender outcome
c) Compare baseline characteristics of study groups d) Applying logistic regression
d) Conduct logistic regression analysis
27. Relative risk is calculated in which of the following
22. Which of the following is the appropriate measure of study designs?
association in a case-control study? a) Cross-sectional study
a) Odds ratio b) Cohort study
b) Prevalence ratio c) Case study
c) Relative risk d) Case control study
d) Incidence
28. State whether true or false. Risk ratio can be calculated
23. State whether true or false. Prevalence ratio is one of in a descriptive cross-sectional study.
the measures of association calculated in an analytical a) True
cross-sectional study. b) False
a) True
b) False 29. In a case-control study to examine the association
between mobile phone use and acoustic neuroma, 24
24. State whether true or false. Hypothesis testing is cases of acoustic neuroma and 72 hospital controls
conducted in an analytical epidemiological study. were recruited from the ENT department of a medical
a) True college in Gilgit. History of mobile phone use (>6
b) False hours/day) was ascertained using a standard
questionnaire. Exposure was present among 16 cases
25. Identify the correct sequence in the steps of data and 18 controls. Calculate the measure of association.
analysis. a) Odds ratio 1.5
i. Identify exposure, outcome and other variables b) Relative risk 1.5
ii. Check data for consistency, duplicates and missing c) Odds ratio 6
values d) Relative risk 6
iii. Examine association between outcome and
exposure 30. In a case control conducted taking 100 autism children
iv. Examine baseline characteristics of the study and 200 normal children in Bhopal city, it was found
population that 90 autism children and 60 normal children had a
a) i, ii, iii, iv history of instrumental delivery. Calculate the measure
b) i, ii, iv, iii of association between instrumental delivery and
c) ii, iv, i, iii autism.
d) iii, i, ii, iv a) 12
b) 21
26. Which of the following is NOT done during the analytic c) 6
stage of data analysis? d) 9
a) Calculating frequency of the outcome in one group

Lecture 19: Ethical framework for health research

1. In which of the following guidelines, discussion on a) Taking informed consent from participants prior to
rationale and justification of risk benefit analysis of study participation
research and voluntary consent in research was b) Giving lot of money to increase study participation
initiated? c) Lack of adherence to study protocol
a) Belmont report d) 'b' and 'c'
b) Helsinki declaration
c) Nuremberg code 7. "Do no harm" concept was emphasized in which of the
d) CIOMS guidelines following ethical principles?
a) Justice
2. In which type of the following study/studies is (are) b) Autonomy
informed consent not necessary? c) Beneficence
a) Investigation of an outbreak d) Non-Maleficence
b) Analysis of mortality data of 2001-2010
c) Using verbal autopsy to determine the cause of 8. Genetic research that involves human participants and
death conducted by a private research institute should
d) All of the above follow
a) ICMR Guidelines
3. In which of the following type of research, ethical b) Genome Policy and Genetic Research [2000]
review is (are) mandatory? c) Both 'a' and 'b'
a) Prevalence of HIV infection using blood d) Neither 'a' nor 'b'
investigation
b) Awareness about diabetes using questionnaire only 9. While conducting research among tribal populations,
c) Calculate out of pocket expenditure using secondary which of the following is recommended?
data a) Consent from the tribal head (Group consent) is
d) All of the above desirable
b) Group consent can replace individual consent
4. Which of the following is not important in the context c) Women can be excluded from informed consent
of an informed consent document? process
a) Detailed description of study procedures d) Confidentiality not required
b) Budget of the study
c) Details regarding compensation and post trial access 10. In a clinical research, the researcher knowingly
to care excludes recruitment of female participants without
d) Contact details of the Principal Investigator any compelling indications.
Which of the following ethical principle does the
5. In the middle of a clinical trial, one participant decides investigator violate?
to withdraw from the trial. But, the investigator a) Justice
pressurizes the participant to continue in the study till b) Autonomy
it completes. Which of the following ethical principles c) Beneficence
does the investigator violate? d) Non-Maleficence
a) Justice
b) Autonomy 11. In which of the following situations is ethics review
c) Beneficence essential?
d) Non-Maleficence a) When already available or archived data are used for
research
6. Which of the following are not ethical practices in b) Involving some risk when some questions are asked,
health research? some samples are collected or some drugs are given

c) ‘a’ and ‘b’ Committee will have to deal with while reviewing the
d) Only ‘b’ research study?
a) Undue inducement
12. A study participant can be forced by the investigator to b) Coercion
continue in a trial against his will. This is in conflict c) Compromising principle of justice
with which of the following ethical principles? d) None of the above
a) Autonomy
b) Justice 20. In an observational study on menstrual hygiene among
c) Beneficence school going girls aged 14 to 16 years, informed assent
d) None of the above will be required to be taken from the adolescent girls.
In addition, informed consent will be required from:
13. The physician should do what is medically indicated, do a) Parent of adolescent girls
good than possible harm. This principle is b) Institutional Head
encompassed in the ethical dimension of: c) Both
a) Beneficence d) None of the above
b) Justice
c) Nonmaleficence 21. State whether true or false. Review of health records
d) Autonomy for research does NOT require approval of institute
ethics committee
14. Study monitors, regulators and ethics committee a) True
members have an authority to verify the consent b) False
documentation of research participants.
a) True 22. A participant wants to withdraw from a study before its
b) False completion. Which of the following principles of ethics
entitles him/her to do so?
15. Which of the following is not true about an Informed a) Autonomy
Consent? b) Justice
a) IC helps participants take an informed decision c) Beneficence
about participation in the research study d) Non-maleficence
b) IC has information on potential risks and benefits of
the study 23. Which of the following does NOT describe ethical
c) IC process intends to protect the study participants principles in research?
d) IC taken by coercion is considered valid a) Nuremberg code
b) Helsinki declaration
16. Which of the following have the guidance in the c) Council for International Organization and Medical
Belmont report? Sciences
a) The procedure of ‘informed consent’ d) Bhore report
b) The basic ethics principles of autonomy, justice and
beneficence 24. When a research study is planned among adolescents
c) Review by ethics committee (12-15 years), the following is NOT required?
d) All of the above a) Assent from participant
e) None of the above b) Consent from participant
c) Consent from parent
17. Which of the following is typically not within the d) Consent from legally accepted representative
domain of ethical review of the proposed research?
a) Novelty of research 25. Non-Maleficence means-
b) Competence of researchers a) Self-respect
c) Relevance of research b) Do no harm
d) To advocate for the study in the community c) Fair and correct
d) Doing good
18. The process of Informed consent can be repeated
several times during the research study if necessary. 26. State whether true or false. Once a participant has
a) True provided informed consent, it cannot be withdrawn.
b) False a) True
b) False
19. As part of evaluation of a new vaccine which requires
taking a daily oral dose of a refrigerated vaccine, the 27. Which of these is NOT a part of informed consent
research team offers to provide a refrigerator to process?
families of participants who don’t have one. Which of a) Confidentiality
the following ethical issues the Institutional Ethics b) Disclosure of risks and benefits

c) Compensation for lost wages a) Evaluate the potential benefit from the study to the
d) Encouraging the person to consent community
b) Protect the rights of the study participants
28. Which of the following statement is NOT correct? c) Sanction funding for the study
a) Compensation for participants is offered for trial d) Re-evaluate the study if and when modified
related injury
b) Research participants can be paid for travel 30. When a particular ethnic group is excluded from a
expenses research study without any valid, scientific reason(s),
c) Payment can be offered to encourage this is breach of -
participation a) Autonomy
d) Wage loss of the participants can be compensated b) Justice
c) Beneficence
29. Which of the following is NOT a responsibility of the d) Non maleficence
Institutional Ethics Committee?

Lecture 20: Conducting clinical trials
1. A study design that randomly assigns participants into is termed as adverse event
an experimental group or a control group is call as b) Adverse events do not have to be caused by the drug
a) Cohort study or therapy under trial
b) Case-control study c) Temporal relationship between study product
c) Randomized controlled trials administration and adverse events is critically
d) Cross-sectional study important
d) All of the above
2. Which of the following statements is (are) true in case
of adverse events in a clinical trial? 3. To ensure that safety and welfare of the research
a) An unexpected clinical/familial/social problem that participants is adequately protected, it is important
occurs during treatment with a drug or other therapy that the clinical trial protocol is critically reviewed for

the following 10. Investigators are required to report adverse events
a) Scientific content occurring during a clinical trial to which of the
b) Ethical issues following agencies?
c) Regulatory norms a) Regulatory authority
d) All of the above b) Sponsor
c) Institutional Ethics Committee
4. Informed consent is provided after explanation of d) All of the above
a) All study procedures
b) Risks 11. A method of allocating treatment such that each subject
c) Benefits has an equal chance of receiving any of the possible
d) All of the above treatments in a clinical trial is known as:
a) Blinding
5. Bodies like Drug Controller General of India (DCGI) and b) Randomization
Health Ministry Screening Committee (HMSC) are c) Allocation concealment
concerned with the following d) None of the above.
a) Regulatory review
b) Scientific review 12. Which of the following statements regarding document
storage and archival after the conclusion of a trial; is
c) Ethics review
correct?
d) All of the above
a) If the data is computerized, there is no need to
archive paper based records.
6. Which of the following is (are) monitored in a clinical
b) The investigator has a right to refuse to show the
trial?
data even to regulatory authorities
a) Adherence to Good Clinical Practice (GCP) c) Archival for a period of 5 - 15 years as per the
b) Documentation of informed consent, randomization requirement of the sponsor may be necessary
and study product administration d) All of the above
c) Adverse events reporting
d) All of the above 13. Which of the following is not true?
a) Data Safety Monitoring Body (DSMB) is an
7. The primary responsibilities of the Data Safety independent entity.
Monitoring Body (DSMB) are to b) DSMB is appointed by the Investigators
a) Periodically review and evaluate the accumulated c) DSMB periodically reviews and evaluates the
study data for participant safety, study conduct and accumulated study data for participants’ safety
progress of trial d) DSMB assures that the scientific integrity of the trial
b) Periodically review and evaluate the is maintained during the period of interim analysis
accumulated study data for participant safety,
study conduct and progress and make 14. An unexpected clinical/ familial/ social problem that
recommendation concerning the continuation, occurs while on treatment with a drug or other therapy
modification, or termination of the trial during participation in a clinical trial without any
c) Periodically make recommendations concerning the judgment about causality or relationship to the drug is
known as:
continuation, modification, or termination of the trial
a) Serious adverse event
d) Decide the randomization sequence
b) Adverse event
c) Reportable event
8. Which of the following best describes the advantages of
conducting a Randomized controlled trial?
a) It is only effective design for overcoming 15. Clinical trials require review at various levels as per the
selection bias of participants in-country guidelines. State whether true or false.
b) The result can be readily generalized a) True
c) It is a simple, uncomplicated and non-regulated b) False
study design
d) It requires small sample size 16. The most common method of preventing potential
harm to study participants is by adhering to ‘trial
9. When is the Informed consent obtained from the stoppage rules’ based on evidence on unacceptable
subjects in a clinical trial? toxicity or adverse effects rates seen during
a) Prior to participation in the trial monitoring. State whether true or false.
b) Just after the trial has started a) True
c) At any point during the conduct of a trial b) False
d) At the end of the trial
17. Which of the following is true about screening protocol

of a clinical trial? 24. Which of the following is FALSE with regard to data
a) Those who are interested in participating in the trial analysis in clinical trials?
participate in an interview may have to undergo a) Baseline characteristics of participants should be
medical examination compared across study arms
b) Eligibility of the potential participant is determined b) Interim analysis can be performed if pre-stated in
in screening the protocol
c) Information on study related procedures and c) Analyses in clinical trials are only descriptive in
inclusion and exclusion criteria are provided by the nature
study investigators to the potential participants d) People who are lost to follow up can be included in
d) All the above three statements are true the analysis
e) None of the above is true
f) Only ‘a’ is true 25. Which of the following is FALSE when dealing with
serious adverse events in a clinical trial?
18. Reimbursements for which of the following raise no a) Making provision for free treatment
ethical questions? b) Informing the regulatory authorities
a) Compensating for the time spent in coming over and c) Taking action only if 1% are affected by the
the loss of daily wages due to participation adverse events
b) For the travel cost involved d) Withdrawing the implicated intervention for the
c) For food expenses affected
d) Only ‘a’ and ‘b’
e) ‘a’, ‘b’ and ‘c’ 26. A trial can be pre-maturely stopped if
a) A significant unanticipated risk is demonstrated
19. Which of the following statements is wrong? b) The investigators lose interest
a) Drug Controller General of India is a Regulatory c) The principal investigator retires
Authority in India d) Minor adverse events are reported
b) Institutional Governing Board is responsible for
scientific review of projects 27. Data Safety Monitoring Body (DSMB) is primarily
c) Institutional Ethics Committee is responsible for responsible for which of the following?
ethics review of a proposal a) Periodically review and evaluate the accumulated
d) None of the above study data for participant safety
b) Periodically review and evaluate the study conduct
20. Which of the following is NOT a method for identifying and progress
and preventing potential harm to study participants? c) Make recommendations concerning the
a) Adverse and serious adverse events reporting continuation, modification, or termination of a clinical
b) Periodic review of the project by Data Safety trial
Monitoring Board d) All of the above
c) Close watch on enrolment targets
d) Regular monitoring of the trial by a pre-identified 28. Which of the following is NOT an advantage of a
monitoring agency Randomized Controlled Trial?
a) Controls for confounding bias effectively
21. State whether true or false. The scientific advisory b) Provides high level of evidence
committee examines the safety and welfare of the c) Can be conducted in the community or hospital
research participants in a trial. d) Blinding in trial eliminates selection bias
a) True
b) False 29. Which of the following statement is FALSE with
regards to a Randomized Controlled Trial?
22. If the project is getting funded internationally, which of a) Adverse events should be reported to the Data
the following committees looks at the regulatory Safety Monitoring Board
affairs? b) Trial related documents must be archived after the
a) Health ministry screening committee trial is over
b) Genetic engineering approval committee c) Drug trials ideally should have a pre-defined
c) Ethics committee stoppage rule
d) All the above d) Ethics committee clearance cannot be
withdrawn after initial approval
23. State whether true or false. In order for a clinical trial
to be ethically appropriate, participants must give their 30. State whether true or false. It is unethical to use a
informed voluntary consent. placebo for the control arm instead of the current
a) True standard of care in a clinical trial.
b) False a) True
b) False

Lecture 21: Preparing a concept for research projects

1. If there are many study objectives, it may be necessary Importance of the study problem and information that
to differentiate the objectives into primary and needs to be generated to address the problem in an
secondary or general and specific objectives effective manner
a) True c) Importance of the study problem, known and
b) False unknown aspects of the problem and information
that needs to be generated to address the problem
2. Which among the following is not a component of in an effective manner
concept paper? d) Information that needs to be generated to address
a) Background and Justification the problem in an effective manner, known and
b) Objectives and Methods unknown aspects of the problem and statement of
c) Expected benefits, Key references and Budget objectives
d) Conclusion
5. Advantages of writing a concept paper include
3. Which of the following is NOT true about references in a) You may be able to organize your ideas
the concept paper? b) It gives an opportunity to stand out and receive a
a) We can cite references in Introduction and Methods positive response from reviewers
section c) You are sure to get funding
b) It is important to write references following d) 'a' and 'b'
standard guidelines
c) Statements should be linked to references 6. The elements of the methods section in the concept
d) We can have as many references as possible proposal needs to be adopted according to the study
design chosen
4. The "Background and Justification" section in the a) True
concept paper should be written in the following b) False
sequence
a) Known and unknown aspects of the problem, 7. The ethics section of the concept proposal should
information that needs to be generated to address the include information about
problem in an effective manner and statement of a) Key measures taken to protect the study
objectives participants
b) Known and unknown aspects of the problem, b) The ethics committee to which the study will be

submitted for approval b) Operational definitions
c) Scientific committee that will review the study c) Sampling technique
d) 'a' and 'b' d) Study procedure
8. Which of the following needs to be spelt out in 16. Which of the following information is not addressed in
"Expected benefits" section of the concept proposal? the ethics section of the concept paper?
a) Expected outputs that the study will generate with a) Information about sample and data storage
timeline b) Key measures taken to project the study participants
b) Proposed immediate action based on research c) The ethics committee to which the study will be
submitted for approval
findings
d) Budget for salary of the projects staff
c) How this research may set agenda for further
research
17. Which of the following is a component of concept
d) All of the above
paper?
a) Abstract
9. Budget estimate is not mandatory in the concept b) Objectives and Methods
proposals. However, it would be very useful to prepare c) Conclusion
the indicative budget for key items d) Discussion
a) True
b) False 18. What is the basis for writing a one page concept paper?
a) Lack of time to draft a complete protocol
10. While writing the concept papers for intervention b) Overcomes inhibitions in drafting a complete
studies, the methods section must have the following protocol
details c) It is mandatory for scientific committee protocol
a) Primary and secondary outcome definitions d) For ethics committee approval
b) Randomization, sequence allocation and allocation
concealment 19. The indicative budget in a concept paper includes
c) Dose, frequency, nature of Intervention salaries, per diem, travel, equipment and supplies
d) All of the above a) True
b) False
11. Immediately after identification of research topic and
statement of objectives, it may be preferable to 20. The concept paper helps agencies for
a) Write protocol a) Screening the proposal for funding
b) Outline one-page concept paper b) Scientific committee approval
c) Prepare dummy tables as per the analysis plan c) Ethics committee approval
d) Seek review by an institutional ethics committee d) Publishing the manuscript
12. References need to be written following standard 21. Which of the following is NOT included in the
guidelines such as International Committee of Medical background section of a concept paper?
Journal Editors (ICMJE) a) Importance of a health problem
a) True b) Known fact about the health problem
b) False c) Prior contribution of the researcher in the topic
d) Knowledge gap in that topic
13. Which of the following is the guideline that can be used
for drafting protocols for a clinical trial? 22. The methods section of the concept paper contains the
a) SPIRIT following:
b) PRISMA a) Key operational definitions
c) CARE b) Conclusions
d) STROBE c) Context of study
d) Novelty of the study
14. Why is concept paper necessary for a research project?
a) It helps to finish the data collection rapidly 23. Which of the following best describes the ‘Expected
b) It helps to organize the ideas Benefits’ section of a concept paper?
c) It helps to get instant approval of ethics committee a) Financial benefit to the funding agency
d) It helps to publish the research quickly b) Policy changes based on the study findings
c) Financial benefit to the researcher
15. Which of the following components are included in the d) Academic improvement of the researchers
background and justification section of the concept
paper 24. Which of the following are components of a concept
a) Context of the study problem paper?

a) Study title and references d) Remuneration for the thesis guide
b) Study title, abstract and references
c) Abstract and references 28. Identify the INCORRECT statement about protocol
d) Study title, results and references writing?
a) A protocol is a must for obtaining the ethics
25. Sampling strategy is discussed in which of the committee approval
following section of a concept paper? b) A well-written protocol is often helpful to draft
a) Background a one-page concept proposal
b) Objectives c) All known facts in a protocol must be supported by
c) Methodology appropriate reference
d) Results c) Peer review helps in improving the quality of a
protocol
26. Which of the following statement is true about the
‘Reference’ section of a concept paper? 29. All the followings are recommended while writing a
a) References must be written following standard concept paper, EXCEPT-
guidelines a) Preparing a concise document
b) Unlimited references are preferred in a concept b) Presenting mostly in bullet forms
paper c) Describing the methods section in detail
c) Reference section is usually an optional component d) Restricting the number of objectives
d) References are usually required for the results
section 30. Which of the following is a consideration in framing the
objectives of a concept paper?
27. A post graduate has mentioned the estimated budget a) Choosing appropriate action verbs
for her thesis to be 50,000 INR in the concept paper. b) Calculating sample size based on the secondary
Which of the following components of the budget may objectives
not be justified? c) Stating broad objectives
a) Salary for data collectors d) All the above
b) Travel cost for data collection
c) Equipment cost

Lecture 22: Elements of a protocol for research studies

1. Description of the intervention is essential in a 3. The details regarding data quality assurance should be
research protocol for written in the following section in the protocol
a) Experimental study a) Data collection
b) Case-control study b) Data analysis
c) Cohort study c) Project implementation
d) Cross-sectional study d) Data entry
2. Inclusion and exclusion criteria should be included 4. The following annexure in the study protocol deals
under the following section in the protocol with toxicity management
a) Sampling a) Study management forms
b) Study population b) Standard operating procedures
c) Study design c) Consent forms
d) Sample size d) Adverse event management form

5. Study population, sample size and sampling are specify all, EXCEPT
included in the following section of the protocol a) The kind of data that will be collected
a) Introduction b) Information about the data collector involved in data
b) Methods collection
c) Objectives c) The detailed manner in which the data collector is
d) Expected Benefits going to collect the data
d) The details of how the collected data will be used
6. First step for writing a successful protocol for policy recommendations
a) Write a one page concept paper
14. Mode of data entry, software for data analysis and plan
b) Identify topic, research question and objectives
for data analysis are included in the following section
c) Write a draft protocol
of the protocol
d) Seek ethics approval
a) Introduction
b) Methods
7. Key outcomes and exposures should be explained
c) Objectives
under d) Expected Benefits
a) Data analysis
b) Data collection tools 15. Which of the following is a step for drafting a successful
c) Sampling protocol?
d) Operational definitions a) Writing an abstract
b) Submitting for peer review
8. Human participant protection paragraph addresses all c) Seeking consent from participants
except d) Data analysis
a) Confidentiality
b) Risks 16. Which of the following statements is true?
c) Compensation a) It is sufficient to mention whether the study is
d) Sample size calculation quantitative or qualitative in study design section
b) The concept paper can contain more than 20
9. Willingness of 'study participants' to participate in the references relating to the study
study is obtained by c) Sample size calculation is not necessary for
a) Informed consent conducting research
b) Oral commitment d) Human subject protection statement should be
included in the methods section
c) Willingness not necessary
17. The introduction can be 40% of the content of the
protocol
10. The section that guides how the objectives lead to
a) True
indicators
b) False
a) Introduction
b) Study design 18. Which of the following sections mentions about the
c) Budget detailed plan for conducting the study
d) Objectives a) Introduction
b) Results
11. Which of the following statements is True regarding c) Methods
the first draft of the protocol d) Discussion
a) The draft is the final document and has to be adhered
to as it is. 19. Which of the following is a part of introduction section
b) The concept paper can be used as an outline for of the protocol?
drafting the first draft of the protocol. a) Inclusion and Exclusion criteria
c) Background with justification, method of conducting b) Detailed budget
the study and expected benefits are stated briefly as in c) Participant safety and protection
the concept paper. d) Background with justification
d) Additional references must not be added.
20. Informed consent, procedures for minimizing
12. It is ideal that the first draft of the protocol participant risk and compensations are included in
a) Exceeds >2000 words which of the following sections
b) Does not exceed >2000 words a) Introduction
c) Exceeds >3000 words b) Abstract
d) Does not exceed >3000 words c) Human subject protection
d) Study procedure
13. Data collection paragraph in the protocol should

21. Which of the following is NOT an appropriate step of mechanisms, EXCEPT-
protocol development? a) Obtaining informed consent from the participants
a) Development of research question b) Reviewing proposal by the ethics committee
b) Preparation of the analysis plan c) Incentivizing target population for participation
c) Development of study tool d) Compensating participants for loss of wages
d) Initiation of data collection
27. Which section of a protocol describes the need to
22. In which of the following section of a protocol, is the maintain anonymity of study participants while
analysis plan written? sharing data to others?
a) Objective a) Human subject protection
b) Results b) Data collection methods
c) Budget c) Data analysis plan
d) Methods d) Expected benefits
23. State whether true or false. Study population and the 28. In the methods section of a protocol, a researcher can
study sample are same. include all the following, EXCEPT-
a) True a) Analysis plan
b) False b) Supportive reference
c) Expected benefits
24. Which of the following is CORRECT about operational d) Quality assurance
definitions in a study protocol?
a) It is part of the background section 29. The number of study participants required for a
b) It spells out the key research gaps research study can be decided by-
c) It should be broad and non-specific a) Pilot study
d) It may be supported by appropriate references b) Sample size calculation
c) Sampling procedure
25. Which of the following component is LEAST d) All the above
appropriate for a project implementation plan?
a) Calculating sample size 30. State whether true or false. Researchers can amend a
b) Coordinating project activities research protocol after re-obtaining the ethics
c) Assigning job responsibilities committee clearance for the amendments made.
d) Preparing project timeline a) True
b) False
26. Human subjects are protected by all the following

Lecture 23: Publication Ethics

1. All of the following statements regarding research c) Submit to many journals; once it gets published in
publications are correct, Except one journal, withdraw it from the other journals
a) Publishing paper is important for getting promotion d) Submit the same manuscript in different languages
in academic institutions to different journals
b) Publishing research findings help to identify the
research gaps 7. A researcher conducted a study to identify risk factors
c) Negative findings in a research should not be for exacerbation of bronchial asthma. The researcher
published was due for job promotion.
d) Publishing research findings improves the However, the researcher was lacking enough
credibility of a researcher publications to ensure promotion. Hence, in order to
have maximum number of publications from the work,
2. A senior resident of Psychiatry department of a medical the researcher decided to produce three different
college wrote a manuscript based on his thesis work. manuscripts instead of one manuscript
He has put his wife's name as a comprehensively covering all aspects of the study.
co-author who is working in the Physiology What is this act called?
department of the same college. Which of the following a) Plagiarism
statements supports the act of the senior resident in b) Falsification
providing authorship to his wife? c) Salami slicing
a) He can give authorship to anyone since it is his d) Fabrication
research work
b) The guide should decide on who should be the 8. Which of the following organizations directly deals
authors with publication ethics?
c) His wife has contributed in designing the a) Indian Medical Association (IMA)
residents’ thesis work b) Committee on Publication Ethics (COPE)
d) It is not a good practice to include researcher from c) World Health Organization (WHO)
different department as authors d) Joint National Committee (JNC)
3. Which of the following is incorrect about authorship? 9. A group of researchers submitted a manuscript for
a) Authorship confers credit, implies responsibility and publication based on a drug trial. Because they did not
accountability of the published work register under the clinical trial registry of India (CTRI),
b) International Committee of Medical Journal Editors one reputed journal rejected the paper. The researcher
recommends criteria on authorship resubmitted the paper in a different journal and this
c) It is mandatory to declare the contribution of each journal published it without asking any queries.
author Which of the following is the correct statement?
d) It is not mandatory that all authors should a) It is necessary to register all drug trials under CTRI
approve the final version of the manuscript b) The journal which published the paper is likely to be
a predatory journal
4. Which of the following is false about plagiarism? c) Both 'a' and 'b' are correct
a) It can be copying and pasting of contents from a d) None of the above
published manuscript
b) It can be copying someone's idea 10. Among the following which is the best practice for
c) It is not considered as a serious publication determining the authorship?
misconduct a) Authorship can be based on the criteria given by
d) 'Urkund' is one of the software used to check ICMJE
plagiarism b) Authorship should be decided after submission to a
journal
5. Which of the following is (are) the consequence(s) of c) It is necessary to include head of the
plagiarism of manuscript? department/institution as a co-author
a) The journal can retract the manuscript d) Authorship can be gifted to friends even if they have
b) Institute can take action on the author/researcher not contributed to that study
c) The researcher loses professional reputation
d) All of the above 11. Which of the following is incorrect about publishing a
research work?
6. You have finished writing a manuscript and plan to a) Publishing paper is important for getting promotion
publish it. Which of the following is the best practice? in academic institutions
a) Submit to multiple journals at the same time b) Publishing research findings helps to identify the
b) Submit to a journal and wait for the journal's research gaps
response c) Common people should not read such research

findings
d) None of the above 19. Which of the following is correct in relation to the
conflict of interest?
12. All clinical trials in India should be registered with a) Conflict of interest is always financial
Clinical Trial Registry of India. b) Conflict of interest necessarily changes the outcome
a) True of interest
b) False c) It is recommended to hide the COI during submission
of a manuscript
13. A neonatologist planned to conduct a clinical trial to d) Readers can determine the influence of COI on
explore the effect of intervention X on hypothermia of conclusion of the paper
the newborn children (Age <7 days) over intervention
A (The current practice). All the following are true 20. An editor of a reputed journal found that most of the
about the trial, EXCEPT- finding of a manuscript matches with a previously
a) Ethics Committee approval is a must to conduct the published paper by different authors. The editor
trial considered it as a case of plagiarism. Which of the
b) The trial should be registered under the Clinical following about plagiarism is true?
Trial Registry of India a) The journal can retract the article, if already
c) Informed consent should be taken from either of the published
parents b) The editor can inform the authors’ institute about it
d) Age appropriate assent is a must in this trial c) The researchers may lose their reputation
d) All of the above
14. Manipulating data is known as fabrication
a) True 21. Which of the following is TRUE regarding a clinical
b) False trial?
a) It is mandatory to register the trial under ‘Clinical
15. Which of the following is correct about determining the Trials Registry of India’ after completing it.
authorship? b) Ethical issues are considerably low in clinical trials
a) The investigators can follow ICMJE guideline to when compared with descriptive studies.
determine authorship c) Informed consent is a must for recruiting a study
b) The sequence should always be based on participant in a clinical trial
alphabetical orders d) Both ‘a’ and ‘c’
c) The investigators should include the head of the
institution’s name irrespective of his/ her contribution 22. Altering the original data to obtain a statistically
d) None of the above significant result by the researcher is known as
a) Fabrication
16. A group of researchers submitted a manuscript in a b) Falsification
reputed journal. Even after 5 months of submission, c) Fascination
they did not receive the peer review comments from d) Fasciation
the journal. The authors decided to submit the
manuscript to a different journal without informing the 23. All the following help in reducing ethical issues
editor of the previous journal. Which of the following associated with research publication, EXCEPT-
term describes the situation best? a) Obtaining the institutional ethics committee
a) Duplicate publication permission
b) Simultaneous submission b) Including a guest author to improve the
c) Self-citation acceptance of the manuscript
d) Breach of confidentiality c) Obtaining permission from the copyright holder to
reproduce a figure
17. Dr. D has copied the idea of Dr. A for his thesis. Copying d) Declaring familial relationship between an author
an idea shouldn’t be considered as plagiarism. and the CEO of the funding agency
a) True
b) False 24. Which of the following is INCORRECT about publishing
research finding?
18. Dr. A is in the process of writing review of literature for a) Publication often helps in career progression and
her thesis. Her guide has instructed her to avoid academic promotion
plagiarism. Dr. A should take all the following measures b) It is a way to communicate research findings with
to avoid plagiarism, EXCEPT- the peer groups
a) Avoid copying and pasting c) Conflicts of interest can be suppressed as it has
b) Acknowledge original sources implication in study findings
c) Take help of anti-plagiarism software d) It identifies research gaps
d) Copy from her own previous work
25. State whether true or false. The first author is mostly proposal to the ethics committee of the institute. The
responsible for addressing the comments received committee found that the proposal is a near copy of an
from the reviewers of the journal. earlier proposal from the same department. This act of
a) True the PG can be best termed as-
b) False a) Fabrication
b) Falsification
26. Submitting a manuscript to more than one journal at c) Plagiarism
the same time is known as- d) Breach of confidentiality
a) Duplicate publication
b) Self-citation 29. State whether true or false. Unpublished work must be
c) Simultaneous publication acknowledged in a manuscript.
d) Peer review a) True
b) False
27. Which of the following is NOT an essential criterion for
authorship? 30. Direct or indirect influence of which of the following
a) Conceptualizing the study aspect is considered ‘conflict of interest’?
b) Drafting the manuscript a) Financial
c) Approval of the final manuscript b) Personal
d) Being departmental head c) Social
d) All the above
28. A Post Graduate in a medical college submitted a

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Basic Course in

Dr. Amit M Shah

Lecture 2: Formulating research question 7

Lecture 3: Literature review 11

Lecture 4: Measures of disease frequency 15

Lecture 5: Descriptive study designs 19

Lecture 6: Analytical study designs 23

Lecture 7: Experimental study designs: Clinical trials 29

Lecture 8: Validity of epidemiological studies 33

Lecture 9: Qualitative research methods: An overview 38

Lecture 10: Measurement of study variables 43

Lecture 11: Sampling methods 47

Lecture 12: Calculating sample size and power 52

Lecture 13: Selection of study population 57

Lecture 14: Study plan and project management 61

Lecture 15: Designing data collection tools 65

Lecture 16: Principles of data collection 69

Lecture 17: Data management 72

Lecture 18: Overview of data analysis 76

Lecture 19: Ethical framework for health research 80

Lecture 20: Conducting clinical trials 85

Lecture 21: Preparing a concept paper for research projects 88

Lecture 22: Elements of a protocol for research studies 93

Lecture 23: Publication Ethics 97

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11. Exposure is assigned by the investigator in which of the

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15. A researcher measures the height of 100 school going

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