The IRB is making a change to the review process of deviations that do not qualify as New Safety Information.

Currently, protocol deviations qualifying as New Safety Information (NSI) are submitted via an NSI submission in IRBIS, and those that do not qualify as NSI (i.e., “all other deviations”) are summarized at continuing review. Under the new process, a summary of all other deviations (i.e. do not constitute NSI) will no longer be required at continuing review. Please see here for more details regarding this change.

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