1. L-9:Writing research protocol
Presented by: Dr.Dawal S. Salve.
PG student MD(Community medicine)
Activity guide: Dr. N.R.Aswar MD(PSM).
Associate Professor.
DR.S.C.G.M.C.Nanded.
Date:04/10/12

2. L-9:Writing research protocol
Components of a research protocol
Title and abstract
Introduction, aims and objective
Context-review of relevant literature
Methodology-research question, study design, description of
methodology, plan of analysis
References- Citation, Citing styles, citing journals, books, internet
references.

3. What is research?
• Research is the systematic collection, analysis
and interpretation of data to answer a certain
question or solve a problem

4. Why a protocol?
To clarify the
research
question
To compile
existing
knowledge
To formulate a
hypothesis and
objectives
To decide about
a study design
To clarify
ethical
considerations
To apply for
funding
To have a
guideline and
tool for the
research team

5. How to judge well-thought out and well-written
protocol?
Is it adequate to answer the research
question(s)and achieve the study
objective?
Is it feasible in the particular set-up for
the study?
Does it provide enough detail that can
allow another investigator to do the study
and arrive at comparable conclusions?

6. Content of the protocol
• Project title
• Project summary
• Project description:
− Rationale
− Objectives
− Methodology
− Data management and analysis
• Ethical considerations
• Gender issues
• References

7. Project Title
• Accurate, short, concise
• Descriptive: should make the main objective
clear, should mention the target population
• Key words: should contain key words for
referencing
– i.e. „Anemia in hiv infected ANC“
– Better: „prevalence of anemia among
HIV infected ANC attending ICTC centre Nanded.“

8. • Concise, one page (about 300 words)
• Stands on its own – no reference to protocol
content
• Summarizes central elements (rationale,
methodology, populations, time frame, expected
outcomes)

9. Statement of the problem
• Why …is the research needed?
• What …is the relevance of the results?
Logical flow of statements:
Magnitude, frequency, and distribution: Affected geographical areas and
population groups. Ethnic and gender considerations.
Probable causes of the problem: What is the current knowledge of the
problem and its causes? Is there consensus? Is there controversy? Is there
conclusive evidence?
Possible solutions: In what ways have solutions to the problem been
attempted? What has been proposed? What are the results?
Unanswered questions: What remains to be answered? What areas have not
been possible to understand, determine, verify, or test?

10. Statement of the problem
Literature review
• Prevents duplication of work, which has been
done
• Clarifies, what others have found addressing the
problem
• Familiarizes with potential methodologies and
methodological errors
• Should convince, that the research is needed!

11. Justification of research
Should be a convincing statement for the need to do
this research
• How does the research relate to the priorities of
the region and the country?
• What knowledge and information will be
obtained?
• What is the ultimate purpose that the knowledge
obtained from the study will serve?
• How will the results be disseminated?
• How will the results be used, and who will be the
beneficiaries?

12. Research hypothesis
Independent
variable
• Describes the relationship between INDEPENDENT
variables (risk factors, predisposing factors) and
DEPENDENT variables (outcome)
• Determines the type of data to be collected and the
type of analysis to be conducted
Dependent
variable
Intervention,
Observation, Control
variable
Make clear
statements!

13. Research objectives
• Simple
• Specific
• Stated in advance.

14. Research objectives
Define a GENERAL OBJECTIVE and derive SPECIFIC
OBJECTIVES
The formulation of objectives will help to:
• Focus the study (narrowing it down to essentials)
• Avoid the collection of data which are not strictly
necessary for understanding and solving the
problem you have identified
• Organize the study in clearly defined parts or phases

15. Research objectives
Objectives should be:
• Logical and coherent
• Feasible
• Realistic, considering local conditions
• Defined in operational terms that can be
measured
• Phrased to clearly meet the purpose of the study
(relevant)
Objectives should be stated in action verbs that illustrate their purpose:
i.e. “To determine…, To compare..., To verify..., To calculate...,To reduce..., To describe...,
etc.

16. Methodology
Important aspect of the protocol
• Assures, that the hypothesis will be proved or
disproved, using the right tools
• Presents a detailed strategy, how the objectives
are achieved
Consider
• operational definitions
• study design
• definition of variables
• sample size
• ethical aspects

17. Methodology
Study design
• The decision on study design needs to be based
on ethics, logistic consideration, economic
aspects and scientific thoroughness.
• The validity of the results including potential bias
and confounding and the generalizability of the
results needs to be a prime concern defining the
study design.
• A causal relationship between exposure and
outcome can be best established in a Clinical
trial
– > Cohort study > Case - control study > Cross-sectional
study > Ecological study

18. Methodology
Study design
Interventional study Observational study
Clinical trial Cohort study
Cross-sectional study
Case – control study
Ecological study

19. Methodology
Definition of variables

20. Methodology
Measurement of observations
• Describe how, when and where the observations
are made? Describe instruments used!
– Questionaire (attach to the protocol)
– Type of interview (describe structure of the interview)
– Laboratory test (refer to literature or personal
knowledge, if established test, or describe in detail, if
not established)
– Clinical examinations (describe gadget/procedure)
Describe all instruments or refer to literature if tools are established.
(for intervention studies or drug trials refer to specific literature/regulations)

21. Methodology
Subjects/ participants
Depending on the type of study, answer the
following questions:
•What are the criteria for inclusion or selection?
•What are the criteria for exclusion?
•In intervention studies, how will subjects be
allocated to index and comparison groups
(Randomization procedure)?
•What are the criteria for discontinuation?

22. Methodology
Data quality control
• Describe measures of data quality control:
– Double data entry
– Consistancy checking
– Data monitor
– Verfication procedures of source data
– Interrater variability measurements

23. Methodology
Sample size
• Sample size calculation is recommeded for
economical and ethical reasons
• Simple statistical packages in the internet
• Level of error, power and expected impact
of exposure on outcome have to be set

24. Methodology
(Intervention)
If applicable, describe:
• Who will be responsible for the
intervention?
• Where will it take place?
• What activities will be performed, and
with what frequency and intensity?

25. Ethical considerations
One of the most important aspects of biomedical
research!
Ask local ethics committee for advice!
Important aspects to consider:
• Data safety / confidentiality
• Any possibly harm/ side effects/ consequences
• Right of discontinuation at any time
• Role of data safety and monitoring board (in trials)
• Alternative treatments/ approaches (in trials)
• Incentives/ Rewards

26. Ethical considerations
Informed consent
Outline how, when and where the patient will be
consented!
Information form should contain:
• Justification for research
• Responsibilities (Who)
• Outline of study
• Risks
• Insurance
• Confidentiality (legal framework)
• Voluntary participation
• A separate consent form is required!
Simple language!
Patients mother tongue!

27. Ethical considerations
Ethics checklist
• Should answer potential questions regarding the
ethics
• Should discuss pros and cons of research design,
selection of subject, measurement and outcome
assessment.
• Should discuss the advantages and
disadvantages of the subject or communities
involved
• Should discuss physical, social and psychological
implications of the research
• Should discuss confidentiality

28. Data management and analysis
Based on objectives consider:
• Coding for variables/ type of variables
• Analysis plan depending on type of variables
• Statistical tests implicated
• (Style of presentation i.e. tables, graphs)
• Data safety and storage

29. References/Bibliography
• Use of standard referencing system:
– Harvard style
• Name and publication year in text
• Alphabetical bibliography
– Vancouver style
• Numbered references
• Continous referencing in text
• Make use of software
– Reference Manager
– Endnote software
See also „A Pratical Guide for Health Researchers“

30. Definitions
• Citing – this is the process of formal recognition,
within your text, of the resources from which you
have gathered your information
• A Citation – this is a passage or phrase quoted
within your text which is supported with evidence
of its source
• Bibliography – a list of the sources that you have
used
• Reference – a detailed description of the item
from which you have obtained your information
Version 1.0
Copyright
© 2009 AQA and its

31. What is the Harvard System?
• Developed in the USA
• Most common system in use
internationally
• A flexible, simple, clear system both for
author and reader
• References are listed alphabetically in the
bibliography and cited in the body of the
text so no footnotes or chapter references
needed

32. What is the Vancouver Referencing Style?
It is a uniform set of requirements for
bibliographic references.
It is a "numbered" style.
It follows rules established by the International
Committee of Medical Journal Editors.
It is also known as: Uniform Requirements for
Manuscripts submitted to Biomedical Journals.

33. How to do in-text citations
 A number is assigned to each reference as it is cited
- in brackets [ ] ( ) or superscript.1
 If the source is referred to again, the same number is
used.
Example:...as one author has put it "the darkest days
were still ahead" [1]: which is well documented in the
literature. [2-5] This proves that "the darkest days were
still ahead". [1]

34. How to create a Reference List
 Reference list should appear at the end of the assignment / report.
 Entries are listed numerically and in the same order that they were
cited in the text.
Example:
1. Baker PN, editor. Obstetrics by ten teachers. 18th ed. London:
Hodder Arnold; 2006.
2. Delbridge ML, Harry JL, Toder R. A human candidate
spermatogenesis gene, RBM1, is conserved and amplified on
marsupial Y chromosome. Nat Genet. 1997; 15: 131-136.

35. Work plan
Who?
Tasks
When?
Where?

36. Budget
The budget should be broken down by:
• Items
– Personnel
– Consumables, equipment, supplies,
communication, funds for patients, data
processing
• Budget justification
– Jusitify the use of each item, considering the
workplan of the study

37. Annexes
• Case Record Forms (CRFs)
• Questionaires
• Patient information form (in required
languages)
• Consent form (in required languages)
• CV of investigators

38. PAHO 2004

40. Methodology
• Research design:
• Research subjects or participants:
• Interventions: drugs or devices.
• Observations:
• Sample size:

41. Ethical considerations
• Approval by ethics review committees:
• Informed decision-making:
Consent form:
A) A statement describing the study and the nature of the subject’s
involvement in it; and
b) A certificate of consent attesting to the subject’s consent.
• Ethics checklist
.

42. Questionnaire Design
•Review of data source and data collection
•Instruments for data collection
•Questionnaire as a tool for data collection tool-types, strengths and
limitations
•Principles of questionnaire design-purpose, type of information, wording
the questions, response rate and rating scales
•Questionnaire Administration-prevalidation,response rate, reliability and
validity