ResMed requires at least one study status update per quarter, unless otherwise specified, to comply with ResMed’s regulatory requirements. Updates should include information on enrollment, device-related adverse events (AEs), protocol deviations, projected publications and study completion dates. Additional requirements for the provision of safety information to ResMed are detailed in a subsequent section. ResMed also requires prompt notification of any amendments to the original protocol after the study has been initiated. An Investigator conducting an IIR is required to provide ResMed with a written report of the final study results. Any planned publications or presentations must be sent to ResMed in advance of submission, according to the IIR Grant Agreement. Upon study closure, the Investigator will be required to certify that the study was conducted, that the ResMed funds and/or device(s) were used solely to conduct or report the study, and that all safety and regulatory reporting obligations were met. Any unused funding and/or device(s) must be returned to ResMed within 90 days of study completion.