This document provides guidance on how to write a research protocol. It explains that a research protocol is a document that describes the research question, hypothesis, objectives, design, methodology, statistical considerations and expected outcomes. It emphasizes that the protocol should communicate the need and nature of the study in a simple, clear manner to convince stakeholders. The document outlines the various sections that should be included in a protocol such as introduction, methodology, analysis plan, references and ethics considerations. It stresses that the protocol should indicate how the study will advance scientific knowledge and potentially impact healthcare, policies or further research. The document provides tips for choosing a feasible, novel topic and refining the research question and objectives. It also discusses various study designs, sampling techniques,

1. How to write a Research
protocol?
Dr.S.Kalpana Ph.D., MBA
Research Officer
Department of Epidemiology
The TN Dr.M.G.R.Medical University
.

2. Research ……….
Research is to see what everybody else
has seen, and to think what nobody
else has thought.
&
Research is a systematic process of
collection, analysis and interpretation of
data for generating new knowledge or to
answer certain questions.
Dr.S.Kalpana, DoE. TNMGRMU 2

3. “To steal ideas from one person is
plagiarism, to steal ideas from
many is research”.”
Dr.S.Kalpana, DoE. TNMGRMU 3

4. What is protocol?
““A document that describes the research
question, hypothesis, objective(s), design,question, hypothesis, objective(s), design,
methodology, statistical considerations and
organization of a trial with budget and
expected outcome.””
Dr.S.Kalpana, DoE. TNMGRMU 4

5. Reasons for Not Writing
• Difficulty knowing
where to start
• Not knowing how to
start
• Anxiety about writing• Anxiety about writing
skills
• Lack of confidence
Dr.S.Kalpana, DoE. TNMGRMU 5

6. Why Research protocol?
Scientific community
Colloborators
Funding agency
Administrators, health
To communicate
and convince the Administrators, health
policy makers
public
Ethical committee
approval
Dr.S.Kalpana, DoE. TNMGRMU 6
and convince the
need and nature
of the study in a
simple sentence

7. Steps in conduct of research
Designing
Planning andPlanning and
Execution
Dr.S.Kalpana, DoE. TNMGRMU 7

8. WHEN should I start planning my research project?

9. CONTENTS OF THE PROPOSAL
(i) Topic
(ii) Introduction
(iii)Review of literature
(iv) Aims and objectives(iv) Aims and objectives
(v) Research design and methods
(vi) Ethical considerations
(vii)Budget
(viii) Appendices and
(ix) Citations

10. INITIAL STEP…………….
Dr.S.Kalpana, DoE. TNMGRMU 10

11. What,Where,When,Why and How?

12. How to choose a research topic?

13. Topic
FINER Criteria
• Feasible (can be done),• Feasible (can be done),
• Interesting,
• Novel,
• Ethical and Relevant (has an implication).

14. If your topic is broad…………………..

15. Narrow the topic down

16. Interest
• Topic must be of interest to the investigators and
to the scientific community
Novelty
• The question should not be about whether the study
has been done before, but whether it will add to the
existing body of knowledge. The addition to
previous studies may be confirmatory, contradictory,
or extend previous findings.

17. Feasibility of topic
• Possible to recruit the number of subjects within the
timeframe
• The research facility available to the investigators
should have the equipment, supplies and othershould have the equipment, supplies and other
requirements
• The investigators must have the required expertise.
• The cost of doing the research must be affordable
and the financial resources available.

18. Choosing a topic -Give Yourself
Ample Time

19. Understanding your Audience
Think about Audience and Time

20. Background/Introduction
• What do we already know about the topic?
• What has not been answered adequately in
previous research and practice?
• How will this research add to knowledge, practice
and policy in this area?
• The hypothesis behind the research design

21. Rationale & background
information
• The Rationale specifies the reasons for conducting
the research.
• It should answer : why the research needs to be• It should answer : why the research needs to be
done and what will be its relevance.
• The magnitude, frequency, affected geographical
areas, ethnic and gender considerations, etc by a
brief description of the most relevant studies.

22. Research Question
The fully refined research question should indicate
Objective of the study,
Specify the major outcome and predictive variables
The setting
Study subjects.
Study design
Study Period
Dr.S.Kalpana, DoE. TNMGRMU 22

23. Refining Research Question
“Do vitamin A protect against human cancer?”
Is the risk of developing lung cancer low among
cohorts with high vitamin A dietary intake,
Fully refined Research Question
cohorts with high vitamin A dietary intake,
compared to cohorts with low vitamin A dietary
intake among male smokers residing in Chennai?
Dr.S.Kalpana, DoE. TNMGRMU 23
Cohort Study

24. Goals Objectives
A goal is a broad statement of what you wish to
accomplish.
The objective represents a step toward
accomplishing a goal.

25. METHODOLOGY
RESEARCH DESIGN
RESEARCH POPULATION
RESEARCH AREARESEARCH AREA
DATA COLLECTION
DATAANALYSIS
ETHICAL ISSUES
RESEARCH LIMITATIONS

26. RESEARCH DESIGN

27. Research Designs
Purpose Study Design
To determine frequency &
burden of a disease
* Cross sectional survey (Prevalence)
* Cohort study (Incidence)
To identify the risk factors * Cohort study
* Case-Control study* Case-Control study
To determine prognosis of a
disease
* Cohort study
To determine efficacy/
effectiveness of new
treatment
•* Clinical trials
•*Community intervention
To evaluate community
programs
* Evaluation
Dr.S.Kalpana, DoE. TNMGRMU 27

28. Research population
Selection criteria
Inclusion Exclusion

29. Sampling Technique
Simple random sampling
Systematic sampling
Stratified sampling
Multi-stage sampling
Cluster samplingCluster sampling

30. Data collection tool

31. Sample size
SAMPLE SIZE
• Denotes the number of subjects to be used in the study
Generally, the sample size for any study depends on the:
• Acceptable level of significance
• Power of the study
• Expected effect size• Expected effect size
• Underlying event rate in the population
• Standard deviation in the population
Incorrect sample size will lead to:
i) Wrong Conclusion ii) Poor quality research
iii) Wastage of resources iv) Ethical problem.

32. Sample size calculation
The range (measured as
a percentage) that your
population’s responses
may deviate from your
sample’s.
The probability that
your sample
accurately reflects the
attitudes of your
population. The
industry standard is
95%.
The total
number of
people whose
opinion or
behavior your
sample will
represent.

33. Clinical trial study
• Who qualifies to participate (selection criteria)
• How many people will be part of the study
• How long the study will last
• Whether there will be a control group and other
ways to limit research bias
• How the drug will be given to patients and at what
dosage
• How the data will be reviewed and analyzed

34. Phases in clinical Trial

37. Methods (contd.,)
Plan of Analysis
• How exposures, outcome variables and other
variables are going to be measured should bevariables are going to be measured should be
described in detail
• A brief description of how the data will be
analyzed and the statistical package if any
should be given
37

38. What test to use when?

39. Ethics and Relevance
• Ethics: Experimentation on human subjects,
involving experimentation on animals should be
justified.
• Relevance(So what): It must have the potential to
advance scientific knowledge, influence clinical
management, influence health policy, or guide
further research.

40. Ethical issues
Researchers have a duty to
‘Protect the life, health, dignity, integrity, right to
self-determination, privacy and confidentiality of
personal information of research subjects’.
Beneficence - first do no harm, maximise
possible benefits and minimise possible harms
‘Informed consent is a process by which a subject
voluntarily confirms his or her willingness to participate
in a particular trial, after having been informed of all
aspects of the trial that are relevant to the subject's
decision to participate’

41. Pilot study
Dr.S.Kalpana, DoE. TNMGRMU 41

42. Time management

43. Budget
Items Total 1st year 2nd year 3rd year Balance10% of the
total
Salary (research
fellow)
7,19,200 2,30,000 2,30,000 2,59,200
Equipment 6,40,000 6,40,000 – –
Books 15,000 15,000 –
Other non-recurring
expenditure
– – –
Recurring
expenditure
9,95,000 3,92,000 5,87,000 16,000
TA/DA 90,000 30,000 30,000 30,000
Institutional support 97,260 – – 97,260
Fee of PI and CoI 90,000 – 90,000
Miscellaneous
expenses
36,000 18,000 18,000
Total 26,82,460 13,25,000 8,65,000 4,92,460 2,68,246

44. Common reasons for rejection
• Too ambitious: too many questions
• Insufficient attention to literature search
• Poor justification
why is it important to answer this question?
what impact does it have on public health?what impact does it have on public health?
• Poorly formulated objectives! Unspecific.
• Inappropriate analysis
• Inadequate description of sampling, study
subject etc
• Absence of pilot test
Dr.S.Kalpana, DoE. TNMGRMU 44

45. The protocol should indicate how the study will
contribute to advancement of knowledge, how
the results will be utilized, not only in
Expected Outcomes of the Study
the results will be utilized, not only in
publications but also how they will likely affect
health care, health systems, or health policies.

46. References
• Books
• Journal articles
• News papers
• Magazine etc.,
• Web address
Dr.S.Kalpana, DoE. TNMGRMU 46

47. RP- Check List
1 Does your question reflect a sound rationale? Yes/No
2 Does your question specify the study population ? Yes/No
3 Does your question refer to the exposure variable?
Yes/No
4 Does your question reflect the outcome of interest? Yes/No
5 Does your question specify the nature of5 Does your question specify the nature of
comparisons to be made? Yes/No
6 Does your question provide sufficient information to
suggest the study design? Yes/No
7 Is your study relevant? Yes/No
8 Is your study feasible? Yes/No
9 Is your study ethical? Yes/No
Dr.S.Kalpana, DoE. TNMGRMU 47

48. Dr.S.Kalpana, DoE. TNMGRMU 48