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Open accessProtocolPersonalised ExerciseRehabilitation FOR people with Multiple long term conditions (PERFORM): protocol for a randomized feasibility trial Sharon Anne Simpson,1 Rachael A Evans ,
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How to fill out protocol for a randomised

01
Clearly define the research question and hypotheses.
02
Describe the study design including randomisation process and allocation concealment.
03
Detail the participant eligibility criteria and recruitment strategies.
04
Outline the intervention or treatment being tested.
05
Specify the outcome measures and how they will be assessed.
06
Address ethical considerations and potential risks to participants.
07
Provide a detailed statistical analysis plan.
08
Include any other relevant information such as study timeline and funding sources.

Who needs protocol for a randomised?

01
Researchers conducting clinical trials to evaluate the effectiveness of a treatment or intervention.
02
Institutional review boards (IRBs) responsible for ensuring ethical standards are met in research studies.
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Regulatory agencies that require detailed protocols for approval of clinical trials.
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A protocol for a randomised study is a document that outlines the plan for conducting a randomised trial, including objectives, design, methodology, statistical considerations, and ethical aspects to ensure the study is conducted systematically and ethically.
Researchers or organizations conducting the randomised study are required to file the protocol, typically with an institutional review board (IRB) or ethics committee, and sometimes with regulatory authorities.
To fill out a protocol for a randomised study, include sections such as title, background, objectives, methodology, patient selection criteria, data collection methods, statistical analysis plan, ethical considerations, and any relevant appendices.
The purpose of a protocol for a randomised study is to provide a clear and detailed plan that guides the conduct of the research, ensuring consistency, accountability, and adherence to ethical standards.
Information that must be reported includes study objectives, designs, participant eligibility criteria, intervention details, randomisation methods, outcome measures, sample size calculations, and data analysis strategies.
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