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Dr. Biju GeorgeAsst ProfessorDept of Community MedicineNodal Officer, IRCMedical College, Calicut
Designing aResearch
Protocol
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What is Protocol ?
Protocol is a set of rule which guides how anactivity should be performed
Written procedures for doing a work
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What is Research Protocol ?
It describes the complete process of thework starting from the problem formulation tothe way we try to get the solution in a
scientific and methodological manner
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Why to write this
To standardize a research method -to ensuresuccessful replication of results by others
Give idea regarding procedures, requiredequipment, instruments, safety precautions,ways of calculation of results and reporting
standards.
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Why is it important ?
Only well written protocol get grants andfunding
Writing / Presentation skills.
It is a proud document to prove our capabilityto analyze a health problem.
Help to avoid Bias and errors
Help multiple centers to follow same thing
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Format of the Research Protocol?
TitleSynopsis of protocol
Rationale and background information
Study objectives
Study design
Study Methodology
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Format of the Research Protocol?
Safety concerns and ethicsData management and storage
Quality control and Quality assurance
Expected outcome of the study
Dissemination of results & publicationpolicy
Program management
References
Appendix
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Title
Concise titles are easier to read.
Titles that are too short may, however, lack
important information.
Authors should include all information in the
title that will make the topic both sensitiveand specific
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Synopsis
Summary of protocol not more than a page
It should summarize all the elements of the
protocol, for example the rationale,objectives, methods, populations, timeframe, and expected outcomes
It should stand on its own
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Rationale and Background
Provide context or background for the studySpecifies the reasons for conducting theresearch in light of current knowledge.
Describe magnitude, frequency, affectedgeographical areas & etc of the problem
Description of the relevant studies published
on the subject
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Rationale and Background
Equivalent to introduction in research paper
It should answer question of
Why the research needs to be done andWhat will be its relevance
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Study Objectives
Primary Objective
Secondary Objective
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Study Design
ExperimentalAnalytical
Descriptive
Reason why a specific design is chosen
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Methodology
Clear cut explanation about how a studywas conducted
Study setting and periodDescribe the setting, locations, and relevantdates, including periods of recruitment, exposure,follow-up, and data collection
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Methodology
Selection and Description of ParticipantsSelection of participants (patients or controls),including eligibility and exclusion criteria and a
description of the source populationAuthors should explain why only certain groupswere included or why some groups wereexcluded
How were they followed up
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Methodology
Technical InformationSource of data
How variables were define & measured. Describemethods, apparatus & procedures in sufficient
detail
Give references to established methods &Describe new or substantially modified methods,
give the reasons for using themIdentify precisely all drugs and chemicals used,including generic name(s), dose(s), and route(s) ofadministration.
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Methodology
Statistics analysis -planStatistical methods with enough detail
Sufficient details regarding the samplingstrategy and adjustments for it
How matching was done
Plan of subgroup analysis
What was done about missing of data / lost to
follow up
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Methodology
Flow diagram
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Safety concerns & Ethical issues
Ethical problems anticipatedWays of tackling it
Safety precautions taken
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Data management and storage
How the data will be managed, includingdata handling and coding for computeranalysis, monitoring and verification
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Quality control & Assurance
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Expected outcome of the study
How the study will contribute toadvancement of knowledge
How the results will be utilized
How they will likely to affect health care,health systems, or health policies
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Dissemination of results &
publication policyDissemination of results in the scientificmedia, to the community, the participants
and to the policy makers where relevantPublication policy should be clearlydiscussed- who will take the lead in
publication and who will be acknowledgedin publications, etc.
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Program Management
Role and responsibility of each memberof the team
Budget
Other supportsCollaborations
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References
References to key original worksShould be verified using either anelectronic bibliographic source, like
PubMed or print copies
Vancouver style of referencing
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Appendix
Questionnaires and interview schedulesInformed consent form
Detailed Budget
Curriculum Vitae of the investigator andCo-investigators
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Develop a style
Be conscious of language and its potential
Rewrite / revise
Learn from good workBe direct, bold and brief
Make the paragraph the unit of composition
Use the active voice
Put statements positively
Omit unnecessary words
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Develop a style
Start on broad frames, make it finer as timeprogress
Arrange the topics to each paragraph
Take a break from writing often
Come back later and read again the writtenpart
Re modifyWorking draft
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