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1st June 2016PERFORM Clinical protocol v 1.0PERFORM Personalised management of febrile illnessCLINICAL PROTOCOL Version 1.0 1st June 2016 Project full title: Personalised Risk assessment in Febrile
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What is clinical study protocol?
A clinical study protocol is a document that outlines the objective, design, methodology, statistical considerations, and organization of a clinical trial. It serves as a guide to ensure the study is conducted consistently and ethically.
Who is required to file clinical study protocol?
Clinical study protocols must be filed by sponsors of clinical trials, including pharmaceutical companies, research institutions, and investigators conducting studies on investigational drugs or devices.
How to fill out clinical study protocol?
To fill out a clinical study protocol, one should define the study's objectives, design the methodology, outline the participant inclusion/exclusion criteria, describe the statistical analysis plan, and ensure adherence to regulatory requirements.
What is the purpose of clinical study protocol?
The purpose of a clinical study protocol is to provide detailed planning for the clinical trial, ensuring that it is scientifically valid, safe, and compliant with regulatory requirements while protecting the rights and welfare of the participants.
What information must be reported on clinical study protocol?
Essential information must include the study's objectives, design, methodology, participant eligibility criteria, interventions, outcome measures, statistical analysis plan, and ethical considerations.
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