Protocol deviation(s): means a minor or administrative departure from the IRBapproved protocol proce 2025

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Protocol deviations occur when an investigator does not implement or follow some aspect of a research study as approved by the IRB. All deviations reflect a failure to comply with the approved study and as such, are instances of potential noncompliance and must be reported to the IRB.
A protocol deviation is considered minor if it does NOT: Impact the health, safety or welfare of subjects or alters the risk/benefit ratio, Compromise the scientific integrity of the data collected for the study, Affect subjects willingness to continue participating in the study.
Protocol deviations can be identified via programmatic or manual processes. The application of risk-based approaches may not identify all protocol deviations. This Decision Tree can guide in the identification and classification of important and non-important protocol deviations.
The rate of protocol deviation (RPD) was calculated by dividing the total amount of site-generated protocol deviations by the total number of visits performed.
In the FDAs guidance on quality management systems for the pharmaceutical industry and current Good Manufacturing Practice (cGMP) regulations, a deviation is described as a result that falls outside the expected range or fails to fulfill a specific requirement.

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The ICH E3 QA R1 defines a protocol deviation as any change, divergence, or departure from the study design or procedures defined in the protocol. The current definition is often over-interpreted leading to the inclusion of a wide scope of items being reported.

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