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Preparation of Article based on the Study Protocol – Pubrica

 

Introduction

Clinical research is carried out following a set of guidelines (protocol) or an action plan. The protocol arranges out the procedures for carrying out the trial. It demonstrates what will be done in the study by describing each important component and how it will be carried out. It also explains the participants' eligibility, the study duration, the medications used, and the tests performed. A chief researcher is in charge of a protocol. Members of the research team will monitor the participants' health regularly to ensure the study's safety and effectiveness.The journal considers protocols for existing or proposed large-scale, prospective research relevant to public health and public health management activities.

Components of a research protocol

 The Clinical trials must be approved and managed by an Institutional Review Board, verifying that the risks are insignificant and that the benefits outweigh the risks. It is an independent body made up of doctors, dentists, statisticians, and community members. The committee guarantees that clinical trials are conducted ethically and that all participants' rights are respected.

1) Title of the study
2) Administrative details
3) Project summary
4) Introduction to the research topic, background (Literature review)
5) Preliminary studies
6) Study objectives and questions—statement of the difficult.
7) Study design, study population, and recruiting techniques, variables list, sample size, data collection techniques, data collection instruments, and analytic plan (analysis of data)

8) Project organization: Work plan (Timeline - proposed schedule)
9) Strengths and limitations of the study
10) Issues for ethical review and approvals



 

Writing the protocol

Protocol writing enables the researcher to analyze and critically analyze published material on the research topic of interest, organize and review project processes, and serve as a guide during the study. The proposal is an essential document that allows the researcher to track the project's progress (4).

1)      Title of the Study: The proposal's title should be precise, brief, simple, and distinct. What is the purpose of the study, and who are the participants? What is the study's setting, and, if appropriate, when will it be launched?

2)      Administrative Details: Following the title page, the following administrative details and a protocol content summary should be included:

·         A list of important sections and sub-sections with page numbers can be found on the contents page.

·         The signature page is signed and dated by senior members of the research team to confirm that the version in question has been accepted.

3)      Project Summary: The summary should be unique, concise, and cover all of the protocol's essentials.

4)      Introduction (Background): The project's background should be brief and direct in its approach to the issue. The strengths, disadvantages, and limitations of the studies. The literature review services should logically lead to a declaration of the proposed project's goals and end with the study's goals and objectives. The review should contain the most recent papers on the subject. The study topic is chosen only after the literature evaluation has been completed and identified gaps.

5)      Study Objectives (Aims): The study questions/hypotheses lead to the study goals or objectives. They are reactions to the possible replies to the research topic or hypothesis being investigated and measured.

6)      Methods and Materials: It should include information on "Where," "Who," and "How" the study will be conducted. It covers the study's design and the procedures and techniques employed to attain the goals. It outlines the variables and explains how they will be measured in detail.

Conclusion

1)      The drafting of a protocol, which results in a brief but comprehensive document that summarises the project, is the most difficult stage of executing a research project. When a proposal is straightforward, free of typographical errors, accurate, and easy to understand, it is successful. To conduct an acceptable study and receive truthful results, it is critical to understand the stages involved in designing a research protocol. The extra time invested in writing a strong protocol will save failures later on and assist data analysis. If the protocol is not properly written and followed, it is doubtful that the project will deliver the results you desire.

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