When do I notify IntegReview when the PI or research personnel deviate from or violate the protocol?
As indicated in IntegReview’s approval letter, significant protocol deviations are to be reported within 10 days of discovery. IntegReview does not consider protocol deviations to be different from protocol violations. Significant protocol deviations are those that deviate from the approved protocol and affect or can potentially affect the safety of subjects. Please utilize IntegReview’s Significant Protocol Deviation Report form available on the FORMS page of our Website.
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- When do I notify IntegReview when the PI or research personnel deviate from or violate the protocol?
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