When submitting a study modification, please make sure that the proposed changes are clearly indicated. Some simple changes can be briefly described in the modification form and included in clean and tracked-changes versions of revised documents. However, more extensive changes may require more explanation and a separate summary. For example, if a sponsor has provided a revised Investigator’s Brochure (IB) for an investigational drug, please make sure the changes are described before submitting it to the IRB. If the IB does not include a summary of changes, please request one from the sponsor. The IRB will also need to know if any of the proposed changes will have an impact locally on subject safety, study procedures, or the study’s risk/benefit ratio. A complete description of the changes will help get your submission through the IRB faster.