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Protocol Deviation Log InstructionalPurpose/Guidance: The protocol deviation log can be used to track any deviation made from the IRB approved protocol. This includes but is not limited to: Researcher
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Slidetodoccomprotocol-deviations-protocol deviations refer to the guidelines and procedures that outline how deviations from the established protocol in a project or study are to be recorded and addressed.
Typically, researchers, project managers, or any stakeholders involved in the execution of a project or study are required to file protocol deviations.
To fill out the protocol deviations, one must provide details such as the nature of the deviation, the reasons for it, the impact on the study, and corrective actions taken.
The purpose of filing protocol deviations is to maintain compliance with regulatory standards, ensure transparency, and effectively manage any issues that arise during a project.
The report must include the specific details of the deviation, including dates, involved parties, description of the deviation, and any corrective actions taken or planned.
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