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The Project About Loneliness and Social networks (PALS): a clusterrandomised trial comparing GENIE with usual care for socially isolated peopled and Version No: Internal reference/ short title: PALS Ethics
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Start by clearly defining the purpose and objectives of the study.
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Develop a detailed plan for data collection, including the variables to be measured and the instruments or tools to be used.
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Describe the procedures and interventions to be performed during the study.
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Clearly define the criteria for participant inclusion and exclusion.
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Determine the sample size and justify the rationale for it.
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Create a schedule for data collection, data analysis, and reporting of results.
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Outline the ethical considerations and obtain necessary approvals from relevant ethics committees.
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Study protocol form outlines the detailed plan for a research study.
Principal investigator is required to file the study protocol form.
Study protocol form can be filled out by providing detailed information about the research plan, methodology, and objectives.
The purpose of study protocol form is to ensure transparency and consistency in research studies.
Information such as research objectives, methodology, participant recruitment, and data analysis must be reported on study protocol form.
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