BCBR - Review

Basic Course in
Biomedical
Research –
Review
Dr. Amit M Shah
Associate Professor
Department of Pharmacology
GMERS Medical College
Gandhinagar
M: 9974820709
This book contains the compilation of PowerPoint presentation of all 23 lectures of ‘Basic course in
Biomedical Research’ along with Assignments (with correct answers) of Cycle 1 (Sep-Dec 2019) and
Cycle 2 (Mar-Jun 2020). MCQs no. 1 to 10 belong to Cycle 1 and MCQs no. 11 to 20 belong to
Cycle 2. I have just compiled all this information for ease of use. I don’t owe any copyright on the
material present in this e-book. It is strictly for study purpose not for the commercial purpose. It can
be helpful for all the faculties/students for completion of ‘Basic course in Biomedical Research’.
Contents
Lecture 1: Introduction to health research 2
Lecture 2: Formulating research question 6
Lecture 3: Literature review 9
Lecture 4: Measures of disease frequency 12
Lecture 5: Descriptive study designs 16
Lecture 6: Analytical study designs 19
Lecture 7: Experimental study designs: Clinical trials 24
Lecture 8: Validity of epidemiological studies 28
Lecture 9: Qualitative research methods: An overview 31
Lecture 10: Measurement of study variables 36
Lecture 11: Sampling methods 40
Lecture 12: Calculating sample size and power 44
Lecture 13: Selection of study population 48
Lecture 14: Study plan and project management 51
Lecture 15: Designing data collection tools 55
Lecture 16: Principles of data collection 59
Lecture 17: Data management 61
Lecture 18: Overview of data analysis 64
Lecture 19: Ethical framework for health research 67
Lecture 20: Conducting clinical trials 71
Lecture 21: Preparing a concept paper for research projects 74
Lecture 22: Elements of a protocol for research studies 78
Lecture 23: Publication Ethics 81
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
have to conduct to find an answer? 15. The policy makers want to know whether introduction
a) Case-control study of a new rotavirus vaccine in the national
b) Field trial immunization programme is resulting in reduction of
c) Ecological study morbidity and mortality from rotavirus disease. Which
d) Case series of the following studies will they have to conduct to
find an answer?
9. What is true about Confounders? a) Case-control study
a) They affect both study variable as well as outcome b) Ecological study
c) Field randomized trial
b) Their effect can be minimized by proper study
d) Case-series
design and through stratified analysis
c) Both 'a' and 'b'
16. What effect does increasing the sample size have upon
d) None of the above
the random error?
a) It increases the random error
10. Which of the following is not a type of study design? b) It has no effect on the random error
a) Qualitative study c) It reduces the random error
b) Observational study d) None of the above
c) Retrospective study
d) Pilot study 17. Which of the following will best describe the scientific
inquiry that seeks to understand the acceptability and
11. Any systematic error in the design, conduct or analysis functionality of a health program?
of a study that results in an erroneous estimate of an a) Basic science research
exposure's effect on the risk of disease is called: b) Translational research
a) Confounding c) Clinical research
b) Bias d) Implementation research
c) Interaction e) None of the above
d) Stratification
18. The following statements describe confounding and
12. Which of the following is not part of ethics review of a effect modification. Which of the statement is/are
project? correct?
a) Informed consent document and procedure a) In a study of relationship between coffee
b) Competence of researcher and institute drinking and oro-pharyngeal cancer; smoking
conducting research is a confounder
c) Sharing and protection of intellectual b) In a study to explore relationship between
property hepatitis B infection and post-infection hepatic
d) Care and support during and after completion sequelae, habit of alcohol drinking acts as an
of research effect modifier and patients with this habit
may be excluded from the study
13. A study was conducted to assess the extrapyramidal c) 'a' and 'b' are correct
side effects of a new antipsychotic drug in patients with d) 'a' and 'b' are wrong
schizophrenia. Many of these patients were smokers
and some of them were on anticholinergic drugs. What 19. Issues regarding shipment of samples and transfer of
was the role of the anticholinergic drugs in this study? data outside the country are examined by:
a) Confounder a) Regulatory review
b) Random Variable b) Ethics review
c) Effect Modifier c) Scientific review
d) Independent Variable d) None
14. Before initiating the study, the Principal Investigator 20. Which of the following disciplines contribute to health
must ensure that various approvals are obtained. research?
Which of the following approvals is/are absolutely a) Bio-medical research
mandatory? b) Biostatistics
a) Scientific committee approval c) Social science research
b) Ethics committee approval d) All of the above
c) Technical committee approval
d) Regulatory authority approval
e) All

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

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

Lecture 4: Measures of disease frequency

1. Which of the following must be considered while 9. In a study among 3400 children aged 5-10 years, 16
measuring occurrence of a disease? children were diagnosed with autistic disorder.
a) The number of people affected by the disease Calculate the prevalence
b) The population size from which the cases of disease of autism per 1000 children
arise a) 4.01
c) The length of the time the population is followed b) 5.53
d) All of the above c) 3.35
d) 4.71
2. __________ is most useful for evaluating the impact of
prevention programmes 10. Statistic used to estimate the risk of acquiring a disease
a) Point prevalence a) Prevalence
b) Period prevalence b) Incidence
c) Case fatality c) Mortality rate
d) Incidence d) All of the above
3. Which one of the following statements is true? 11. What is the appropriate measure when a researcher
a) High cure rate can increase the prevalence of a wishes to know the burden of a particular disease in
disease terms of the number of deaths it causes in a specified
b) Low case fatality can reduce the prevalence of a geographical region and population?
disease a) Incidence density
c) Both 'a' and 'b' are true b) Case fatality
d) High cure rate and high case fatality can reduce c) Attack rate
the prevalence of a disease d) Disease specific mortality
12. If health policy makers want to evaluate the impact of a

4. Measures of disease frequency
prevention program, which is the appropriate measure
a) Incidence
to be considered?
b) Prevalence
a) Period prevalence
c) Birth rate
b) Incidence
d) 'a' and 'b' c) Point prevalence
d) Case fatality
5. A measure that reflects severity of an acute infectious
disease 13. Select the correct statement among the following
a) Case fatality ratio a) Prevalence of a disease will increase when it has a
b) Incidence rate high cure rate
c) Prevalence b) Prevalence of a disease will decrease when it has a
d) Mortality rate low case fatality ratio
c) Prevalence of a disease will increase when it has
6. Incidence data can be used to measure the occurrence a low cure rate
of disease with gradual onset d) Prevalence of a disease will increase when it is acute
a) True in nature
b) False
14. What is the appropriate epidemiologic measure to
7. This measure reflects the impact of a disease on determine the severity of an acute disease?
population in terms of death a) Incidence rate
a) Incidence density b) Prevalence
c) Mortality rate
b) Case fatality
d) Case fatality ratio
c) Disease specific mortality
d) Attack rate
15. Cumulative incidence is otherwise known as
a) Attack rate
8. While measuring the frequency of a chronic disease in a
b) Case fatality rate
community in terms of Incidence per 1000 persons per c) Mortality rate
year, and point prevalence per 1000 persons, what is b) Morbidity rate
the expected pattern of incidence and prevalence?
a) Low prevalence, high incidence 16. The healthcare professionals working in an intensive
b) High prevalence, low incidence care unit were asked whether there has been an
c) Both prevalence and incidence will be similar increase in the number of new pneumonia cases. Which
d) None of the above statements are true of the following factor(s) is inappropriate in the
calculation of cumulative incidence?

a) Number of new cases of pneumonia during a specific identified with Hepatitis B infection. Calculate the
period of time prevalence of Hepatitis B per 1000 population.
b) Total number of people at risk of developing the a) 5.2
disease in that population during the same period of b) 4.2
time c) 3.2
c) Pre-existing cases of pneumonia d) 2.2
d) Both ‘a’ and ‘b’
19. Which of the following condition tends to increase the
17. When measuring the frequency for an acute infectious prevalence of a particular disease?
disease in a community in terms of incidence per 1000 a) High cure rate
persons per year and point prevalence per 1000 b) Low case fatality ratio
persons, how will the pattern of incidence and c) Short duration
prevalence be? d) Emigration of patients
a) High prevalence
b) Low incidence 20. Which of the following is true about incidence density?
c) Both prevalence and incidence will be similar a) Numerator has number of new cases
d) Low prevalence and high incidence b) Also called cumulative incidence
c) Denominator is number of persons at risk
18. Among 25000 population in a city, 105 residents were d) Numerator has person-years at risk

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 15. The advantage of an ecological study is that
c) Both 'a' and 'b' a) It is analytical in nature
d) None of the above b) It will cover individual level information on risk
factors and disease
9. Case reports can include presentation of c) It will be useful to test hypotheses
a) Unique features/symptoms of a disease d) It will be useful to generate hypotheses
b) Rare manifestation of common disease
c) New or unfamiliar diseases 16. In a tertiary care hospital, a surgeon collected
d) All of the above information on quality of life and outcome among a
small group of (about 15) post-operative patients after
using a novel surgical device. But this is not sufficient
10. Advantage of the ecological study is
to establish the efficacy of the surgical device because
a) Relate rate of disease and exposure
a) There is no comparison group
b) Useful to test hypothesis
b) There is no information of risk factors
c) Useful to study rare diseases
c) We do not have details of the outcome
d) All of the above d) We do not have individual level data
11. A researcher can assess the following by conducting a 17. Population census is a
descriptive study EXCEPT a) Cross sectional survey
a) Population in which the disease was prevalent b) Ecological study
b) Period in which the disease occurred c) Analytical study
c) Risk factors of the disease d) None of the above
d) Place distribution of the disease
18. One of the major limitations of a cross-sectional study
12. The following study design provides group exposure is that
and group response/outcome without knowing the a) It is time consuming
individual exposure and response for a specific health b) It has lower validity
problem c) It does not establish disease etiology
a) Ecological study d) It requires a large sample size
b) Cross sectional survey
c) Case report 19. Characteristic of a cross sectional study is that
d) Case series a) We can calculate the incidence of a disease
b) We can test a hypotheses
13. Which of the following study design will be helpful if c) It is difficult to conduct
the department of health wants to know the burden of d) Exposure and outcome are assessed at the same
a particular disease? time
a) Ecological study
b) Cross sectional survey 20. If a researcher wishes to estimate the incidence of
c) Case series Myocardial infarction cases among a group of women
d) Case report using oral contraceptive pills followed up for 10 year,
the researcher has to carry out
14. A clinician comes across an unusual presentation of a a) Case series
particular neurological disorder. If the clinician b) Cohort study
describes this single case in detail and publishes the c) Cross sectional study
same in a journal, then it will be called d) Ecological study
a) Analytical study
b) Case report
c) Cross sectional survey
d) Ecological 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 period
a) Incidence in unexposed is higher than exposed b) Loss to follow up can introduce bias
b) Incidence in exposed is higher than unexposed c) Relative risk can be calculated
c) Relative risk is significant d) Temporal association with the risk factor can be
d) Incidence in the exposed and unexposed groups established
are same
18. Odds ratio of more than one indicates
15. Women aged above 35 years were screened for the a) Odds of exposure among cases is lower than the odds
HPV (Human papilloma virus) infection and those who of exposure among the controls
had HPV infection were then followed for several years b) Odds of exposure among cases is equal to the odds
to predict the risk of developing cervical cancer. This of exposure among the controls
study is known as c) Odds of exposure among cases is higher than the
a) Prospective cohort odds of exposure among the controls
b) Retrospective cohort d) Exposure is negatively associated with the disease
c) Case control
d) Cross sectional 19. If there is a comparison group in an epidemiological
study design, it is called
16. Which of the following is appropriate regarding a a) Descriptive
cohort study? b) Analytical
i. Multiple exposures can be examined c) Ecological
ii. Appropriate for studying rare exposures d) None of the above
iii. Expensive and time consuming
iv. Appropriate for studying rare diseases 20. Which of the following statements about case
a) Both (i) and (ii) control/cohort studies is correct?
b) Both (iii) and (iv) a) Case control study always establishes temporal
c) Both (ii) and (iv) association
d) Both (ii) and (iii) b) Cohort study establishes temporal association
c) Cohort has lower level of evidence than case-control
17. Which of the following statement regarding the cohort d) Do case control for rare exposures and cohort for
study is FALSE? rare diseases
a) Suitable to study a disease with long latency

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 17. Which of the following can eliminate the problem of Co-
affect the study outcome intervention?
d) Appropriate implemented informed consent a) Random sampling
procedure as well as long-term care and support to b) Allocation concealment
trial participants help to overcome several ethical c) Informed consent
concerns d) Blinding
14. Which of the following can be considered as an 18. Which of the following is not true in case of a clinical
advantage of a double blinding in a randomized trial?
controlled trial? a) Clinical trials are planned experiments designed to
a) Equally distributes known and unknown assess the efficacy of an intervention
confounders in experiment and control arm b) Clinical trials usually involve comparing the
b) Ensures that participants adhere to the protocol outcomes in two or more groups of individuals
c) Gives benefits of an intervention to some of the study c) Clinical trials are usually free from selection bias
participants d) Clinical trials are usually prospective in nature
d) Prevent bias that arises from researchers being
able to influence the data due to knowledge of 19. Which of the following trials assesses effectiveness of a
allocated groups new vaccine?
a) Phase 1 trial done in healthy volunteers
15. Biased outcome ascertainment results from: b) Phase 2 trial done in a susceptible population
a) Participants reporting symptoms or outcomes c) Phase 3 trial done in healthy volunteers
differently d) Phase 3 trial done in a susceptible population
b) Investigators eliciting symptoms or outcomes
following a standardized technique 20. Which of the following is not true about a randomized
c) None of the above control trial?
d) Both "a" and "b" a) Baseline characteristics of intervention and control
groups must be similar
16. In a clinical trial, what is the main purpose of b) Investigator bias can be minimized by double
randomization? blinding
a) To get more power for data analysis c) The sample size depends on the hypothesis being
b) To reduce investigator bias tested
c) To get groups with comparable baseline d) Drop outs should be excluded from the analysis
characteristics
d) To ensure optimum number of participants in each
trial arm

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 the respiratory ward for other conditions. What type of
and effect of exposure on health outcomes in study bias will be introduced by virtue of recruiting controls
population pertains to from the hospital who are potentially different from the
a) External Validity general population?
b) Internal Validity a) Selection bias
c) Bias b) Information bias
d) Confounding c) Confounding
d) Random error
12. Blinding in an epidemiological study is a way to deal
with 17. A researcher studied the effect of coffee drinking on
a) Chance Myocardial Infarction. The effect of coffee drinking on
b) Selection Bias Myocardial Infarction was distorted because of the
c) Information Bias presence of a third factor, i.e. smoking. This
d) Sampling Error phenomenon is called as
a) Correlation effect
13. Better recall of exposure only among the cases in a case b) Confounding
control study can result in c) Recall bias
a) Information bias d) Measurement error
b) Confounding
c) Investigator bias 18. Which of the following method is used to address for
d) Selection bias known confounders at the designing stage of a study?
a) Matching
14. The ability of a tool to correctly measure what it is b) Regression
supposed to measure is called as c) Stratification
a) Precision d) Adjusted analysis
b) Validity
c) Reliability 19. Systematic distortion of the truth by study subjects is
d) Consistency called as
a) Plagiarism
15. Bias may distort the association between exposure and b) Chance
outcome among the study participants c) Confounding
a) True d) Prevarication
b) False
20. Crude association in the presence of a confounder is the
16. A case control study was conducted to know the effect actual causal association
of smoking on lung cancer among hospitalized patients. a) True
The controls were recruited from patients admitted to b) False

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? 19. Which of the following statement is “False” about focus
a) Structured interview group discussion.
b) In depth Interview a) Focus group discussions help understand local
c) Participant Observation terminologies
d) Focus Group Discussion b) Group interaction is integral for an effective
discussion
17. In qualitative research, researchers interpret the social c) Heterogeneity of the group is a pre-requisite
reality from the participants’ point of view. d) Audio and video recordings are done with prior
a) True consent
b) False
20. Triangulation is the use of multiple methods, multiple
18. Which of the following statements is “Incorrect” about theories and or multiple sources for a comprehensive
in-depth interviews? understanding of the topic in question
a) Findings are always generalizable a) True
b) The transcripts are time consuming to analyze b) False
c) Helps understand sensitive issues
d) Useful when participants are knowledgeable on a
particular topic

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 d) 14.0
d) 75
19. All the following are examples of a nominal variable
17. The average of the absolute deviations of the EXCEPT
observations from the arithmetic mean is known as a) Gender
a) Variance b) Age
b) Inter-quartile range c) Place of residence
c) Mean deviation d) Colour of eyes
d) Standard deviation
20. Which of the following is true about inter-quartile
18. In a study, a researcher was interested in measuring range?
the haemoglobin levels of 10 participants. The values a) It describes the middle value of the distribution
are 10.0, 8.5, 12.0, 14.0, 11.5, 13.5, 9.0, 12.0, 11.3, 7.5. b) It divides the distribution into two halves
What is the mode of this distribution? c) It covers the middle 50% of observations
a) 7.5 d) It is affected by the extreme values in the
b) 12.0 distribution
c) 10.9

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

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 15. The design effect should be calculated after completion
determination? of the study and it, need not be counted at the design
a) Desired confidence level stage.
b) Desired precision a) True
c) Magnitude of the population variance b) False
d) All of the above
16. When estimating sample size for a cross-sectional
10. Which one of the following statements is false? study, we need to account for
a) Design effect is a relative change in the variance due a) Expected proportion of characteristic of interest
b) Estimated design effect, in case of cluster sampling
to use of clusters
c) Population size
b) As the magnitude of the expected effect
d) All the above
increases, the required sample size increases
c) The population variance is unknown in general and
17. The power of a study
has to be estimated
a) Does not influence the sample size
d) Larger the sample size, smaller the sampling error b) Represented as ‘α’
c) Can be defined as the probability of correctly
11. A type-I error occurs when rejecting null hypothesis when it is false
a) The null hypothesis is rejected when it is false d) Represented as the probability of making a Type I
b) The null hypothesis is not rejected when it is false error
c) The null hypothesis is not rejected when it is true
d) The null hypothesis is rejected when it is true 18. The following are needed to calculate sample size for
analytical studies using simple random sampling
12. Which of the following is true about β error? method EXCEPT
a) It is the probability of correctly rejecting the null a) Desired value for the probability of α
hypothesis when it is false b) Magnitude of the expected effect based on previous
b) It is the probability of accepting the null studies
hypothesis when it is false c) Desired value for the probability of β
c) It is the probability of rejecting the null hypothesis d) Estimated design effect
when it is true
d) It is the probability of making a Type I error 19. A researcher wants to estimate the prevalence of
surgical site infection following cesarean section at a
13. All the following are essential statistical considerations tertiary care hospital. What would be the minimum
for sample size calculation EXCEPT number of sample size to estimate the magnitude of
a) Desired precision surgical site infection following cesarean section if it is
b) Anticipated proportion of factor of interest estimated that the proportion of surgical site infection
c) Sampling method will be 10% in the hospital considering 5% absolute
d) Allocated budget precision and 95% confidence level (Z α/2 = 1.96).
a) 100
14. For each confounder/variable added in the study b) 138
empirically 10% increase in the sample size should be c) 148
made. d) 158
a) True
b) False 20. Precision is described as a measure of how close an
estimate is to the true value of a population parameter.
a) True
b) False

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

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 19. Smart objectives are goals that are designed to be be
infections were recorded in patients who underwent specific, measurable, achievable, relevant and time-
incision appendectomy compared with those who had bound. Which of the following is an illustration of non-
a laparoscopic procedure. Which of the following measurable objective?
statement/s is/are true in such a scenario? a) Incidence of colorectal cancers in Indian adult men
a) This association may simply be owing to the b) Experiences shared by victims of domestic
presence of a confounding factor violence
b) Association between the two can be better studied c) To determine if regular skin emollients applied from
in randomized controlled clinical trials 2 weeks of age reduced development of atopic
c) Both 'a' and 'b' dermatitis by age 12 months in the general infant
d) None population
18. In a study to evaluate the effectiveness of a new
medication, which of the following will generate a 20. Validity of a research can be improved by:
stronger evidence? a) Taking the true representative sample of the
a) Comparing outcomes among those receiving population
medication with those not receiving the same. b) Eliminating extraneous factors and collecting
b) Comparing outcomes among those receiving higher detailed information on confounding factors
doses of medication with those receiving lower doses c) 'a' and 'b'
c) Comparing adverse events and drug reactions d) None of these
among those receiving medication and those not
receiving medication
d) All of the above

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

Lecture 16: Principles of data collection

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

a) True 18. Which of the following statement is true regarding data
b) False collection for an epidemiological study?
a) Reliability refers to consistency of information
15. All of the following are true about a ‘question by b) Accuracy is the ability of a measurement to be
question guide’, except- correct on an average
a) It is a document for the data collectors c) Both ‘a’ and ‘b’
b) It helps in maintaining uniformity of the data d) None of the above
collection
c) It helps participants on how to respond 19. Who is mainly responsible to check the accuracy of data
d) It clarifies doubts on data collection collection instruments before leaving the location?
a) Field investigator
16. Time pressure during data collection may result in b) Field supervisor
dilution of the data quality c) Principle investigator
a) True d) Study participant
b) False
20. All the following statements are true about training of
17. Which one of the following is the proper way of the data collectors, except-
validating the data? a) Essential to ensure good quality data
a) Repetition of full data collection in the same b) The investigators should choose the right people
population c) Communication skill is important for the data
b) Data collection in a new population collectors
c) Repetition of data collection in a randomly d) Onsite training is not essential for data
selected subset in the same population collectors
d) Repeat data collection not required

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)

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

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’ beneficence
d) Only ‘b’ c) Review by ethics committee
d) All of the above
12. A study participant can be forced by the investigator to e) None of the above
continue in a trial against his will. This is in conflict
with which of the following ethical principles? 17. Which of the following is typically not within the
a) Autonomy domain of ethical review of the proposed research?
b) Justice a) Novelty of research
c) Beneficence b) Competence of researchers
d) None of the above c) Relevance of research
d) To advocate for the study in the community
13. The physician should do what is medically indicated, do
good than possible harm. This principle is 18. The process of Informed consent can be repeated
encompassed in the ethical dimension of: several times during the research study if necessary.
a) Beneficence a) True
b) Justice b) False
c) Nonmaleficence
d) Autonomy 19. As part of evaluation of a new vaccine which requires
taking a daily oral dose of a refrigerated vaccine, the
14. Study monitors, regulators and ethics committee research team offers to provide a refrigerator to
members have an authority to verify the consent families of participants who don’t have one. Which of
documentation of research participants. the following ethical issues the Institutional Ethics
a) True Committee will have to deal with while reviewing the
b) False research study?
a) Undue inducement
15. Which of the following is not true about an Informed b) Coercion
Consent? c) Compromising principle of justice
a) IC helps participants take an informed decision d) None of the above
about participation in the research study
b) IC has information on potential risks and benefits of 20. In an observational study on menstrual hygiene among
the study school going girls aged 14 to 16 years, informed assent
c) IC process intends to protect the study participants will be required to be taken from the adolescent girls.
d) IC taken by coercion is considered valid In addition, informed consent will be required from:
a) Parent of adolescent girls
16. Which of the following have the guidance in the b) Institutional Head
Belmont report? c) Both
a) The procedure of ‘informed consent’ d) None of the above
b) The basic ethics principles of autonomy, justice and

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? e) ‘a’, ‘b’ and ‘c’
a) Those who are interested in participating in the trial
participate in an interview may have to undergo 19. Which of the following statements is wrong?
medical examination a) Drug Controller General of India is a Regulatory
b) Eligibility of the potential participant is determined Authority in India
in screening b) Institutional Governing Board is responsible for
c) Information on study related procedures and scientific review of projects
inclusion and exclusion criteria are provided by the c) Institutional Ethics Committee is responsible for
study investigators to the potential participants ethics review of a proposal
d) All the above three statements are true d) None of the above
e) None of the above is true
f) Only ‘a’ is true 20. Which of the following is NOT a method for identifying
and preventing potential harm to study participants?
18. Reimbursements for which of the following raise no a) Adverse and serious adverse events reporting
ethical questions? b) Periodic review of the project by Data Safety
a) Compensating for the time spent in coming over and Monitoring Board
the loss of daily wages due to participation c) Close watch on enrolment targets
b) For the travel cost involved d) Regular monitoring of the trial by a pre-identified
c) For food expenses monitoring agency
d) Only ‘a’ and ‘b’

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

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

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 term describes the situation best?
d) None of the above a) Duplicate publication
b) Simultaneous submission
12. All clinical trials in India should be registered with c) Self-citation
Clinical Trial Registry of India. d) Breach of confidentiality
a) True
b) False 17. Dr. D has copied the idea of Dr. A for his thesis. Copying
an idea shouldn’t be considered as plagiarism.
13. A neonatologist planned to conduct a clinical trial to a) True
explore the effect of intervention X on hypothermia of b) False
the newborn children (Age <7 days) over intervention
A (The current practice). All the following are true 18. Dr. A is in the process of writing review of literature for
about the trial, EXCEPT- her thesis. Her guide has instructed her to avoid
a) Ethics Committee approval is a must to conduct the plagiarism. Dr. A should take all the following measures
trial to avoid plagiarism, EXCEPT-
b) The trial should be registered under the Clinical a) Avoid copying and pasting
Trial Registry of India b) Acknowledge original sources
c) Informed consent should be taken from either of the c) Take help of anti-plagiarism software
parents d) Copy from her own previous work
d) Age appropriate assent is a must in this trial
19. Which of the following is correct in relation to the
14. Manipulating data is known as fabrication conflict of interest?
a) True a) Conflict of interest is always financial
b) False b) Conflict of interest necessarily changes the outcome
of interest
15. Which of the following is correct about determining the c) It is recommended to hide the COI during submission
authorship? of a manuscript
a) The investigators can follow ICMJE guideline to d) Readers can determine the influence of COI on
determine authorship conclusion of the paper
b) The sequence should always be based on
alphabetical orders 20. An editor of a reputed journal found that most of the
c) The investigators should include the head of the finding of a manuscript matches with a previously
institution’s name irrespective of his/ her contribution published paper by different authors. The editor
d) None of the above considered it as a case of plagiarism. Which of the
following about plagiarism is true?
16. A group of researchers submitted a manuscript in a a) The journal can retract the article, if already
reputed journal. Even after 5 months of submission, published
they did not receive the peer review comments from b) The editor can inform the authors’ institute about it
the journal. The authors decided to submit the c) The researchers may lose their reputation
manuscript to a different journal without informing the d) All of the above
editor of the previous journal. Which of the following


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Basic Course in

Lecture 2: Formulating research question 6

Lecture 3: Literature review 9

Lecture 4: Measures of disease frequency 12

Lecture 5: Descriptive study designs 16

Lecture 6: Analytical study designs 19

Lecture 7: Experimental study designs: Clinical trials 24

Lecture 8: Validity of epidemiological studies 28

Lecture 9: Qualitative research methods: An overview 31

Lecture 10: Measurement of study variables 36

Lecture 11: Sampling methods 40

Lecture 12: Calculating sample size and power 44

Lecture 13: Selection of study population 48

Lecture 14: Study plan and project management 51

Lecture 15: Designing data collection tools 55

Lecture 16: Principles of data collection 59

Lecture 17: Data management 61

Lecture 18: Overview of data analysis 64

Lecture 19: Ethical framework for health research 67

Lecture 20: Conducting clinical trials 71

Lecture 21: Preparing a concept paper for research projects 74

Lecture 22: Elements of a protocol for research studies 78

Lecture 23: Publication Ethics 81

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12. If health policy makers want to evaluate the impact of a

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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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