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Participant Information Sheet/Consent Form Interventional Study Adult providing own consent Box Hill Hospital Title Randomized, double blind, placebo controlled and parallel dose group trial to investigate
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01
Start by identifying the purpose and objectives of the study protocol.
02
Include a detailed background and rationale for the study.
03
Specify the study design, including the type of phase and any relevant interventions.
04
Provide clear inclusion and exclusion criteria for participant selection.
05
Outline the measures and interventions to be implemented during the study.
06
Describe the primary and secondary outcomes to be assessed.
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Include a detailed statistical analysis plan.
08
Address ethical considerations and obtain necessary approvals.
09
Clearly define the roles and responsibilities of the study team.
10
Ensure proper documentation and record keeping throughout the study.

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A study protocol phase outlines the specific procedures and plans for conducting a clinical study, including objectives, design, methodology, and statistical analysis.
Researchers and sponsors conducting clinical trials are required to file a study protocol for each phase of the study.
To fill out a study protocol phase, provide detailed information about the study's objectives, design, methodology, participant criteria, and data analysis plans, ensuring compliance with regulatory requirements.
The purpose of a study protocol phase is to ensure that the study is conducted systematically and ethically while providing clear guidelines for investigators and participants.
The study protocol must include information such as study objectives, design, methodology, participant selection criteria, treatment plans, data collection methods, and safety measures.
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