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PROTOCOL COVER RESTUDY TITLE:PRINCIPAL INVESTIGATOR:Name and title of principal investigator(s) responsible for the trial with address and phone numberCoInvestigators: Investigators responsible for
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An investigator-initiated interventional study protocol is a research study designed and initiated by an investigator, rather than a pharmaceutical company or sponsor, aimed at assessing the effects of an intervention on specific health outcomes.
Investigators or research teams conducting the study are required to file the investigator-initiated interventional study protocol with the appropriate regulatory and ethics bodies.
To fill out an investigator-initiated interventional study protocol, researchers must provide detailed information on the study design, objectives, methodology, participant recruitment, data management, and ethical considerations following specific guidelines set by regulatory authorities.
The purpose of the investigator-initiated interventional study protocol is to ensure a structured approach to research that safeguards participant welfare, maintains scientific integrity, and facilitates regulatory oversight.
The information that must be reported includes study title, background and rationale, study objectives, design, inclusion/exclusion criteria, interventions, measurements, timeline, statistical analysis plan, and ethical considerations.
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