designing a research protocol chest cme

7/31/2019 Designing a Research Protocol Chest CME

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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



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



Study Objectives

Primary Objective

Secondary Objective



Study Design

ExperimentalAnalytical

Descriptive

Reason why a specific design is chosen



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



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



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.



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



Methodology

Flow diagram



Safety concerns & Ethical issues

Ethical problems anticipatedWays of tackling it

Safety precautions taken



Data management and storage

How the data will be managed, includingdata handling and coding for computeranalysis, monitoring and verification



Quality control & Assurance



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



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.



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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