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CHAPTER THIRTEENStudy Initiations chapter discusses a number of activities that must be completed before a
study site can begin enrolling subjects. Topics include: study initiation documents, financial
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What is study initiation?
Study initiation is the process of officially starting a research study by submitting all necessary documentation and obtaining approvals.
Who is required to file study initiation?
The principal investigator or sponsor is required to file study initiation.
How to fill out study initiation?
Study initiation is typically filled out by submitting a protocol, informed consent form, and other required documents to the appropriate regulatory bodies.
What is the purpose of study initiation?
The purpose of study initiation is to ensure that all necessary approvals are in place before starting a research study.
What information must be reported on study initiation?
Study initiation typically includes information about the study design, objectives, methods, and ethical considerations.
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