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STUDY PROTOCOL: Body Composition and Lipid Metabolism at Rest and During Exercise: A Cross-sectoral and Prospective Analysis Version 1 dated 08.11.2017INVESTIGATORS Dr Javier Gonzalez Mr Oliver ChrzanowskiSmithADDRESS Department

How to fill out study protocol

How to fill out a study protocol:

1. Begin by clearly defining your research question or objective. This will serve as the foundation for your study protocol and guide the entire research process.
2. Next, outline the study design and methodology you intend to use. This includes selecting the appropriate research methods, sample size calculations, data collection techniques, and any necessary statistical analyses.
3. Specify the inclusion and exclusion criteria for your study participants. This defines the characteristics required for individuals to be eligible for inclusion in your research and those that would disqualify them from participating.
4. Detail the recruitment process for obtaining study participants. Describe how you plan to identify and approach potential participants, ensuring that appropriate consent and ethical considerations are addressed.
5. Outline the data collection procedures. Specify the type of data to be collected, the instruments or tools to be used, and any relevant protocols or guidelines for data collection. This may include questionnaires, interviews, medical tests, or observations.
6. Include a section on data management and analysis. Describe how data will be organized, stored, and analyzed, including any statistical methods that will be employed to answer your research question.
7. Address the ethical considerations of your study. Explain how you will ensure the privacy, confidentiality, and well-being of your participants. Include information on obtaining informed consent and any ethical approval or oversight from relevant bodies.
8. Provide a timeline or schedule for the study. Break down the research process into specific time periods or milestones, indicating when each task or phase of the study will be completed.

Who needs a study protocol?

A study protocol is essential for various individuals or groups involved in the research process. These include:

1. Researchers: The study protocol serves as a road map for researchers, providing clear instructions and guidelines on how to conduct the study. It ensures consistency and standardization in data collection, analysis, and interpretation.
2. Institutional Review Boards/Ethics Committees: These bodies review and approve the research study to ensure that it meets ethical guidelines and protects the rights and welfare of study participants. The study protocol is a crucial document for their assessment.
3. Funding Agencies: For studies seeking financial support, funding agencies require a detailed study protocol to assess the scientific merit, feasibility, and potential impact of the research. The protocol helps them determine if the study aligns with their funding objectives.
4. Publication Journals: When submitting research for publication, many journals require the submission of a study protocol along with the manuscript. This allows reviewers and editors to evaluate the research process, identify potential biases or flaws, and ensure transparency.

In summary, a study protocol is an essential document that outlines the plan, procedures, and ethical considerations of a research study. It is necessary for researchers, ethical bodies, funding agencies, and publication journals to ensure the scientific integrity, transparency, and ethical conduct of the study.

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What is study protocol?

A study protocol is a document that outlines the objectives, design, methodology, statistical considerations, and organization of a research study.

Who is required to file study protocol?

The principal investigator or lead researcher is typically responsible for filing the study protocol with the appropriate regulatory bodies.

How to fill out study protocol?

A study protocol is typically filled out by providing information on the research objectives, study design, methodology, inclusion/exclusion criteria, statistical analysis plan, and ethical considerations.

What is the purpose of study protocol?

The purpose of a study protocol is to provide a detailed plan for conducting the research study, ensuring transparency, reproducibility, and ethical conduct.

What information must be reported on study protocol?

Information such as research objectives, study design, methodology, inclusion/exclusion criteria, statistical analysis plan, and ethical considerations must be reported on the study protocol.