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CLINICAL TRIAL PARTICIPANT Patient Transfer Pack Final Version 1.0 03 October 2019Important Information Enclosed This infant is enrolled in the FEED1 trial. This pack contains everything required
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01
Start by clearly outlining the research question or hypothesis that the randomised protocol is aiming to address.
02
Define the study design, including the randomisation procedure that will be used.
03
Provide detailed information on the study population, including inclusion and exclusion criteria.
04
Describe the interventions or treatments that will be compared in the study.
05
Outline the primary and secondary outcome measures that will be used to assess the effectiveness of the interventions.
06
Include a detailed plan for data collection and analysis.
07
Ensure that the protocol complies with relevant ethical guidelines and regulations.

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01
Researchers conducting clinical trials or other types of studies that involve randomisation.
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Regulatory bodies and ethics committees that review and approve research protocols.
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Funding agencies that require a detailed protocol as part of the grant application process.
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A protocol for a randomised trial is a detailed plan that outlines the objectives, design, methodology, statistical considerations, and the organization of a study, ensuring that the trial is conducted in a systematic and standardized manner.
The principal investigator or the lead research institution is typically required to file the protocol for a randomised trial, often in conjunction with regulatory bodies or ethics committees.
To fill out a protocol for a randomised trial, researchers should include sections on background and rationale, objectives, study design, participant selection, interventions, outcome measures, statistical analysis plan, and ethical considerations.
The purpose of the protocol for a randomised trial is to provide a clear and comprehensive framework guiding the study's implementation, helping to ensure scientific integrity and reproducibility while protecting the rights and welfare of participants.
The protocol must report information such as study objectives, trial design, participant eligibility criteria, intervention details, outcome measures, statistical analysis methods, and compliance with ethical standards.
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