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).
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
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
To formulate a
To decide about
a study design
To apply for
To have a
tool for the
5. How to judge well-thought out and well-written
Is it adequate to answer the research
question(s)and achieve the study
Is it feasible in the particular set-up for
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:
− Data management and analysis
• Ethical considerations
• Gender issues
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
– 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
• Summarizes central elements (rationale,
methodology, populations, time frame, expected
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
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
• Prevents duplication of work, which has been
• Clarifies, what others have found addressing the
• Familiarizes with potential methodologies and
• Should convince, that the research is needed!
11. Justification of research
Should be a convincing statement for the need to do
• How does the research relate to the priorities of
the region and the country?
• What knowledge and information will be
• 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
12. Research hypothesis
• 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
14. Research objectives
Define a GENERAL OBJECTIVE and derive SPECIFIC
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
• Realistic, considering local conditions
• Defined in operational terms that can be
• Phrased to clearly meet the purpose of the study
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...,
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
• operational definitions
• study design
• definition of variables
• sample size
• ethical aspects
• 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
• A causal relationship between exposure and
outcome can be best established in a Clinical
– > Cohort study > Case - control study > Cross-sectional
study > Ecological study
Interventional study Observational study
Clinical trial Cohort study
Case – control study
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
– 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)
Depending on the type of study, answer the
•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
•What are the criteria for discontinuation?
Data quality control
• Describe measures of data quality control:
– Double data entry
– Consistancy checking
– Data monitor
– Verfication procedures of source data
– Interrater variability measurements
• 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
If applicable, describe:
• Who will be responsible for the
• 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
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
Outline how, when and where the patient will be
Information form should contain:
• Justification for research
• Responsibilities (Who)
• Outline of study
• Confidentiality (legal framework)
• Voluntary participation
• A separate consent form is required!
Patients mother tongue!
27. Ethical considerations
• Should answer potential questions regarding the
• Should discuss pros and cons of research design,
selection of subject, measurement and outcome
• Should discuss the advantages and
disadvantages of the subject or communities
• 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
• 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“
31. What is the Harvard System?
• Developed in the USA
• Most common system in use
• 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
32. What is the Vancouver Referencing Style?
It is a uniform set of requirements for
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
Example:...as one author has put it "the darkest days
were still ahead" : which is well documented in the
literature. [2-5] This proves that "the darkest days were
still ahead". 
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.
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.
The budget should be broken down by:
– Consumables, equipment, supplies,
communication, funds for patients, data
• Budget justification
– Jusitify the use of each item, considering the
workplan of the study
• Case Record Forms (CRFs)
• Patient information form (in required
• Consent form (in required languages)
• CV of investigators
• Research design:
• Research subjects or participants:
• Interventions: drugs or devices.
• Sample size:
41. Ethical considerations
• Approval by ethics review committees:
• Informed decision-making:
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
•Principles of questionnaire design-purpose, type of information, wording
the questions, response rate and rating scales
•Questionnaire Administration-prevalidation,response rate, reliability and
Notas del editor
Formation of the topic Hypothesis
Gathering of data
Analysis of data
revising of hypothesis
iteration if necessary
Study design – causal relationship between exposure and outcome is relevant
Ethical considerations - in new TB drugs I still need to cure the patients
Order is not relevant
Methodological errors – effectiveness of DOTS in Chochrane – did not look at resistance, not Rifa – resistance – missed important outcome.
After statement of the primary objective, secondary objectives may be mentioned. Young investigators are advised to resist the temptation to put too many objectives or
over-ambitious objectives that cannot be adequately achieved by the implementation of
Good example for the superiority of trial – HRT from woman – later WHI trial......
Simple language mother tongue!
For studies in humans (or involving human biological materials), the protocol must
be approved by the local, institutional or equivalent ethics committee and/or national
ethics committee. For animal studies approval is required from the animal welfare committee of the
institute or its equivalent. If no such committee exists, a statement signed by the principal
investigator(s) should indicate that the research will be carried out in accordance with
the International Guiding Principles for Biomedical Research involving Animals