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Form FHS011: Study deviationHREC office use only (FWA00001637; IRB00001938) This serves as acknowledgement of a protocol deviation as described below. Chairperson of the REC signatureDatePrincipal
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Form fhs011 study deviation is a document used to report any deviations or changes in a study protocol during a clinical trial.
The principal investigator or sponsor of a clinical trial is required to file form fhs011 study deviation.
Form fhs011 study deviation must be completed by providing details of the deviation, including the reason for the deviation, the impact on the study, and any corrective actions taken.
The purpose of form fhs011 study deviation is to ensure transparency and regulatory compliance in clinical trials by reporting any deviations from the approved study protocol.
Information such as the nature of the deviation, the reason for the deviation, the impact on the study, and any corrective actions taken must be reported on form fhs011 study deviation.
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