The IRB recently updated guidance in the Investigator’s Manual (see Part 8) outlining when protocol deviations under the control of the study team may not require report to the IRB.  The revised guidance specifies that any planned protocol deviations must be submitted to the IRB prior to implementation unless necessary to eliminate an apparent immediate hazard; however, some types of minor deviations that have already occurred may not require report if they meet specific criteria outlined in the guidance.