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INSTITUTIONAL ETHICS REVIEW COMMITTEE PROTOCOL DEVIATION/VIOLATION FORM EC Reference No.: CT Protocol No: Principal Investigator: Inst./Dept.: Protocol Title: *Protocol Deviation: means a minor or
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What is protocol deviation/violation form?
Protocol deviation/violation form is a document used to report any instances where the study protocol was not followed as outlined.
Who is required to file protocol deviation/violation form?
Researchers, study coordinators, or any personnel involved in the study are required to file protocol deviation/violation form.
How to fill out protocol deviation/violation form?
Protocol deviation/violation form should be filled out with details of the deviation, including what happened, when it occurred, and the potential impact it may have on the study.
What is the purpose of protocol deviation/violation form?
The purpose of protocol deviation/violation form is to document any deviations from the study protocol and ensure transparency and accountability in the research process.
What information must be reported on protocol deviation/violation form?
Protocol deviation/violation form must include details such as the nature of the deviation, the reason for the deviation, and any corrective actions taken.
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