Protocol is nothing but an outline for the research project you are going to conduct and for your plan. For writing a good protocol the researcher should completely review and analyze the existing literature on the respective topic. Evaluate the steps used in those projects and plan the process for your research which will be a guide for your study. With the help of your research proposal you can witness the progress in your process.
- Title of the Study
Your title for the proposal should answer the questions like “What is the study about, Where is the setting of the study, who are the targets, When it is launched”. The title should be short, accurate, identify and concise.
The proposal has to explain clearly about the objective of study, purpose of your research and your target audience. Try to produce your title within 12 to 15 words with maximum of required information related to the topic. It should clearly state the area in which you are focusing on your research also the methodology you chose in an accurate, relevant, compact, attractive, informative and easily understandable way.
- Administrative Details
Next to title page, the summary of protocol content and below mentioned administrative details should be written:
The list of headings and sub-headings in each section, with their respective page number should be given.
The signature page included in this should be signed with date by a senior member of the team to verify whether they have approved it or not.
Contact details of the respective team members should be added like telephone number, postal and email address.
- Project Summary
The project summary should collectively produce the whole protocol in a concise and distinctive way.
- Introduction (Background)
While writing thesis you should focus on all sides that is limitations, advantages and disadvantages. The background information about the topic should be very clearly addressing the subject and also concise.
Conclusion of the introduction should explain how much your research will contribute to the existing knowledge. The literature review written should start with an aim of the project that is proposed and end up with stating the objectives and aims of your study. You should select a topic for your research and find gaps from existing one. You have to add the recently published article from your respective field. The introduction part should explain about the significance of your topic, gaps you identified, reason behind your research and the benefits your study could produce for the field. Your research question must be written with concise and precise details because it will be the foundation of your research. To make the readers’ clear about the problem identified, the definitions provided for it should be in a straight forward way.
- Study Objectives (Aims)
This section describes about the goal you want to achieve in your thesis. The main goal of your research project should be mentioned explicitly. Those aims should only be based on the research topic and they have to come from your literature review.
The research question you build will produce the aim of your study. They will provide with the possible answers for your hypotheses or research question at initial stage. The aim of your research should be concise, logical, feasible, realistic and coherent and also should consider the local conditions by focusing on the research purpose to achieve the goal. For instance: If you want to conduct research to know about the students’ knowledge on dental carries from the primary school name “KSA” the you have to focus more on its treatments, causes and measures taken to prevent it.
The objective you choose for your research should be SMART (“Specific, Measurable, Achievable, Relevant and Time based.”)
- Methods and Materials
This section should describe about whom, how and where the research is going to be conducted. This section discuss about the techniques and procedures which are followed to reach your research objective. You have to mention about the process which you have followed to collect and analyze the data. It also explain about the variable and techniques used to measure it. Methodology is considered as the important section of protocol. If you follow a correct methodology you can make sure that your hypothesis will be accepted. It could also provide you with a clear strategy to achieve your goals.
This main heading is further divided into subheadings:
Study design (intervention study, case-control, cross-sectional, RCT and etc.):
You have to give proper justification for selecting a particular design. The design foe your study is very much important to acquire valuable and reliable research results.
Study population (Study subjects):
Mention the population on whom you are going to conduct research and the place. Also justify your choice with explanation.
Sample size:
Calculating the size of sample is advised because to avoid the ethical and economic issues. The calculation of sample size should be discussed; even the power of it should also be explained.
Proposed intervention:
It is important to provide the complete description related to the proposed intervention. The whole process will be recorded and will be analyzing the order in which they occur.
Data collection methods, instruments used:
The Questionnaires, Retrospective data, Instrument Description, Tools used in collecting data, techniques undertaken for testing reliability and validity of the instruments used have to be submitted.
- Data Management and Analysis Plan
To write this section you have to statistical advice from proper statistician. To analyze the hypotheses or research question we have to know about the analysis plan and the suitable statistical test along with the appropriate references. List of variables which are used for analyzing and the statistical analysis which is required to assess the result of your research, have to be prepared.
If you use any computer program to do analyses then make sure to discuss about the software and its respective version which is used.
- Project Management
You have to manage your work by following a work plan which is nothing but an outline of all the works to be done in each section. You have to schedule timeline to complete a work. Working according to timeline will help you in maintaining structure of your research.
- Strengths and Limitations
To avoid wastage of resources it is essential to discuss about the strength as well as the limitation of a study. For instance: “what study can achieve or cannot achieve is important”.
- Ethical Considerations (Issues for Ethical Review and Approvals)
Before starting your study you should get approval from the ethics committee” also ensure whether the steps involved are within the “Declaration of Helsinki”.
- Operational Planning and Budgeting (Budget Summary)
You have to mention about the budget for study-manpower, instruments and transportation, also attach that in the annexure. Cost of everything like personnel, equipment, consumables, communication, data processing supplies and funds should be included.
- Reference System
It is nothing but organizing the collected data from researchers. Citing all the sources will help you to track them, so referencing is an important aspect. You have to properly cite the sources and provide acknowledgement to avoid plagiarism.
- Annexure
Attach the following annexure at last in the protocol:
Informed consent
Letter of ethics committee
Study questionnaire
Budget details
Curriculum Vitae of Co-investigator and Chief investigator
(CRF) Case Record Forms
