Designing a Research Protocol

Dr. Biju George Asst Professor Dept of Community Medicine Nodal Officer, IRC Medical College, Calicut Radar Networks 1

What is Protocol ?
Protocol is a set of rule which guides how an activity should be performed

Written procedures for doing a work

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What is Research Protocol ?

It describes the complete process of the work starting from the problem formulation to the 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 ensure successful replication of results by others

Give idea regarding procedures, required equipment, 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 and funding Writing / Presentation skills. It is a proud document to prove our capability to 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?

Title Synopsis of protocol Rationale and background information Study objectives Study design Study Methodology

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Format of the Research Protocol?

Safety concerns and ethics Data management and storage Quality control and Quality assurance Expected outcome of the study Dissemination of results & publication policy 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 sensitive and 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, time frame, and expected outcomes It should stand on its own

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Rationale and Background

Provide context or background for the study Specifies the reasons for conducting the research in light of current knowledge. Describe magnitude, frequency, affected geographical 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 and What will be its relevance

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Study Objectives
Primary Objective Secondary Objective

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Study Design
Experimental Analytical Descriptive Reason why a specific design is chosen

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Methodology

Clear cut explanation about how a study was conducted

Study setting and period

Describe

the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection

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Methodology
Selection and Description of Participants
Selection

of participants (patients or controls), including eligibility and exclusion criteria and a description of the source population Authors should explain why only certain groups were included or why some groups were excluded

How were they followed up

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Methodology
Technical Information
Source

of data How variables were define & measured. Describe methods, apparatus & procedures in sufficient detail Give references to established methods & Describe new or substantially modified methods, give the reasons for using them Identify precisely all drugs and chemicals used, including generic name(s), dose(s), and route(s) of administration.
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Methodology
Statistics analysis -plan
Statistical

methods with enough detail Sufficient details regarding the sampling strategy 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 anticipated Ways of tackling it Safety precautions taken

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Data management and storage

How the data will be managed, including data handling and coding for computer analysis, monitoring and verification

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Quality control & Assurance

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Expected outcome of the study

How the study will contribute to advancement 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 policy

Dissemination of results in the scientific media, to the community, the participants and to the policy makers where relevant Publication policy should be clearly discussed- who will take the lead in publication and who will be acknowledged in publications, etc.

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Program Management
Role and responsibility of each member of the team Budget Other supports Collaborations

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References
References to key original works Should be verified using either an electronic bibliographic source, like PubMed or print copies Vancouver style of referencing

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Appendix
Questionnaires and interview schedules Informed consent form Detailed Budget Curriculum Vitae of the investigator and Co-investigators

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Develop a style
Be conscious of language and its potential Rewrite / revise Learn from good work Be 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 time progress Arrange the topics to each paragraph Take a break from writing often Come back later and read again the written part Re modify Working draft

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