When reviewing a proposed modification, remember that reviewers can (and should!) ask for summaries of complicated submissions and/or a description of what the modification means for the study. These items are sometimes within the revised document itself, e.g. a revised Investigator’s Brochure (IB) will have a list of revisions in the first few pages of the document, or the PI may have attached a separate document with changes or described them in the modification form. Be sure to check these areas first, but if you can’t find a summary and need one, please either write a contingency or get in touch with the office staff. If there’s enough time before the meeting at which the modification is to be considered, the staff might be able to get the summary uploaded into CLARA in time for you to review it. Note the PI also should have submitted information regarding whether the proposed changes will have an impact locally on subject safety, study procedures, or the study’s risk/benefit ratio. If this information isn’t included in the submission, feel free to ask for it!