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9.1Protocol Violations, Deviations, and Exceptions
DefinitionsProtocol Deviation(s): means a minor or administrative departure from the IRB approved
Protocol procedures (e.g., the Protocol, informed
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What is protocol violations deviations and?
Protocol violations deviations are instances where the agreed upon protocol in a study is not followed or deviated from.
Who is required to file protocol violations deviations and?
The principal investigator or research team is usually required to file protocol violations deviations.
How to fill out protocol violations deviations and?
Protocol violations deviations forms may vary by institution, but generally requires detailed information on the deviation, the reason for it, and any corrective actions taken.
What is the purpose of protocol violations deviations and?
The purpose of filing protocol violations deviations is to document and correct any deviations from the study protocol to ensure the integrity and validity of the research.
What information must be reported on protocol violations deviations and?
The information reported on protocol violations deviations usually includes the nature of the deviation, the date it occurred, the reason for it, and any actions taken to address it.
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