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For clinical investigations, the PI must obtain IRB approval before purposefully deviating from the protocol unless the deviation is to prevent imminent harm to subjects.
Examples of minor protocol violations include, but are not limited to: Routine safety lab work for a participant without new clinical concerns and a history of previously normal lab values is inadvertently omitted at a study visit or performed outside the protocol-defined window.
An investigator may deviate from the protocol whenever necessary to eliminate apparent immediate hazards to the subject, i.e. protect the subjects health, rights or welfare. For example, a study medication should be stopped if a subject develops a medically significant adverse reaction during administration.
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.
For protocol deviations, reporting to WCG IRB is required only for deviations that harmed a subject or placed a subject at risk of harm and a deviation made without prior IRB approval to eliminate an immediate hazard to a subject.
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While FDA regulations do not require the reporting of all protocol deviations as defined in the Draft Guidance, investigators are required to maintain records of all protocol deviations in device investigations.

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