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Protocol Deviation or Violation Report To fulfil ICH GCP requirements, any deviations or violations of the approved protocol must be notified to the reviewing REC. The Principal Investigator (PI)
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The form is a report that the principal investigator must complete for the site.
The principal investigator is required to file the form.
The form can be filled out online or submitted via mail.
The purpose of the form is to provide information about the research site.
The form asks for details about the research conducted at the site.
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