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Protocol Deviation/Violation Reporting Form Human Subjects ResearchNaval Medical Center Portsmouth, VA Contact Clinical Investigation Department at (757) 9535939Protocol Deviation: A protocol deviation
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The protocol deviation/violation reporting form is a document used to report any deviations or violations from the protocol in a research study.
Researchers, study coordinators, and other personnel involved in the research study are required to file the protocol deviation/violation reporting form.
The form typically requires information such as the nature of the deviation/violation, its impact on the study, corrective actions taken, and any potential risks to participants.
The purpose of the form is to ensure transparency, accountability, and compliance with the study protocol and regulatory requirements.
Information such as the nature of the deviation/violation, its impact on the study, corrective actions taken, and any potential risks to participants must be reported on the form.
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