How to Write a Research Protocol

Writing a Research Protocol
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What is a protocol?
The research protocol forms an essential part of a research project.
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A well written protocol is necessary for applications to funding bodies, university and ethics committees.
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As your
research ideas develop

into a workable study a written protocol will help to formalise your ideas and gain feedback from others through peer review.
The protocol can act as a manual for members of the research team to ensure they adhere to the methods outlined.
As your study gets underway, the protocol can then be used to monitor the studys progress and evaluate its outcomes.
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The protocol encourages you to think about the study rigorously and provides communication between all of the people involved.
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Before beginning your research protocol you should consider the following points.

What is your research question? Why does it matter? How will you address this question? (i.e. what methods will you use?) Is your research question clear? Are your research methods appropriate?
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The Structure of a Research Protocol
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Title
The title clearly identifies the study and may contain a brief description of the study design and objectives.
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Investigators/Researchers
Everyone who will make a valuable contribution to the study should be named and their contact details given.
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Summary
Summarise the aims or objectives of the study

Give a brief outline of the design and methods.
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Introduction
1.
The introduction should outline the background to the research
A critical review of the current knowledge or literature.
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Introduction
2.
Any gaps in the evidence should be identified as should the potential value of furthering knowledge in this field, such as theoretical or clinical applications of the study outcomes.
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Introduction
3.
The research hypothesis should also be included in this section,

with an explanation of the reasons for undertaking the work.
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Aims & Objectives
Outline concise and precise objectives that should follow on from the hypothesis.
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Aims & Objectives
What are the differences between aims & objectives? Writing useful and appropriate aims and objectives isn't an easy task, made more difficult by the imprecise definition of the terms and vague distinctions between the two.
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Aims & Objectives
Aims are a broad general statements of what the study is to achieve.

An aim for a course may be, "Students should acquire skills of research methodology" or, "Students should develop the ability to think creatively and independently about new research problems".
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Aims & Objectives
Objectives are usually more specific statements of what is to be done.

They are statements of what a student is expected to know and be able to do upon completion of the learning exercise.
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Aims & Objectives
AIM: To investigate three new resin based composite materials. OBJECTIVES: To Measure the Degree of Conversion To measure the Vickers hardness To compare the two outcome measures
Study Design & Methods
Study Design.
What study design is most appropriate to answer your particular research question?
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Loctaion.

Where will the research take place? Your study may take place in a number of different sites, You need to address any practical issues involved, such as safety procedures, access etc.
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Subjects/Patients.
Detailed information regarding your subjects should be given. Describe the study population, why they were chosen. Describe the methods by which subjects will be identified and recruited Inclusion & exclusion criteria will be used.
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You will need to justify your sample size Sample size calculations It may also be necessary to describe the criteria for participation Participant retention strategies and withdrawal criteria.
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Randomisation methods.
Some research strategies require a random allocation to the different experimental groups or interventions.
You will need to explain what randomisation methods you will use.
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Methods of assessment or measurement.

What data will be collected and why. What instruments will you use and are they the most appropriate? Equipment it should be clearly described.
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Data Collection, Management & Analysis
Explain how the data will be collected and managed and who will have access to it. The method of the data analysis should also be specified and may include the following points: Method of data entry Plan of analysis, including assumptions of analysis Data analysis package
Study Administration & Ethical Issues
Outline the methods by which the patient/subjects interests will be safeguarded. For example, the process of risk limitation, how you will maintain confidentiality or anonymise patients data. Ethical approval
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Resource Requirements
The resource implications to the host organisation and any other involved departments should be defined in this section. In addition you must outline the timetable/schedule of the research and all costs.
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Study Plan
You may wish to include a study plan, showing a brief summary or flow chart of the order, site and timing of all study procedures. It may also be useful to include consent forms & participant information in appendices.
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Supervision
Where applicable, the protocol should name the individual(s) who will supervise the research project and the intended arrangements for the supervision.
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Dissemination & Outcome
How will the studys findings be made available? State whether you intend to publish or present the findings.
Journal** Conference
Thesis
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If you have been, thanks for listening.
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How to Write a Research Protocol

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How to Write a Research Protocol

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Writing a Research Protocol

August 7, 2012 Belgrade 2010 1

The research protocol forms an essential part of a research project.

research ideas develop

The Structure of a Research Protocol

Summarise the aims or objectives of the study

The introduction should outline the background to the research

A critical review of the current knowledge or literature.

The research hypothesis should also be included in this section,

Aims & Objectives

Aims & Objectives

Aims & Objectives

Aims are a broad general statements of what the study is to achieve.

Aims & Objectives

Objectives are usually more specific statements of what is to be done.

Aims & Objectives

Study Design & Methods

Study Design & Methods

Study Design & Methods

Study Design & Methods

Study Design & Methods

Study Design & Methods

Methods of assessment or measurement.

Data Collection, Management & Analysis

Study Administration & Ethical Issues

Dissemination & Outcome

If you have been, thanks for listening.

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