Here in the office we’ve noticed the occasional “Required Change” created by an IRB reviewer creeping back into our reviews. Please note that the “Required Change” option is used by offices other than IRB. When writing contingencies or comments, please use the “contingency” option for information that you expect to be sent back to the PI for a response. The “note” option can be used for general comments about the study that you’d like to note in CLARA, and also to make comments to the PI about something that does not require a PI response. Please also keep in mind that items written as notes or contingencies will be immediately visible to the study team when the “attach to letter” box is checked, so we ask that that box NOT be checked until the actual contingency letter is drafted. That’s because nothing is ever final until it’s final, and it’s only final once it’s put into a letter. Draft contingencies may be revised or even eliminated after discussion in a meeting, and may never wind up in a letter. Also, some PIs routinely check on their studies’ progress in CLARA, and start trying to respond to contingencies before they’re finalized and returned to the PI. When they realize there’s no way to respond to an unsent contingency in CLARA, they start wondering if they’re doing something wrong and calling the office to ask for help. All we can tell them to do is to wait until they receive a contingency letter. So please don’t check the “attach to letter” box — let the person drafting the eventual letter handle that.