The institution and/or investigator has the responsibility for reporting safety events to their local regulatory authority (ex: FDA or other Competent Authority), or IRB/EC, as required per relevant local and federal regulations. ResMed has the ethical and legal responsibilities to collect and analyse safety information on its investigational and marketed products so that the company can fully understand their risk-benefit profile and provide accurate safety information to regulatory authorities, physicians and patients. As an independent investigator-sponsor conducting research involving ResMed products, you play an important role in monitoring the study and reporting all relevant safety events to ResMed. A cumulative listing of adverse events related to ResMed-manufactured devices must be provided to ResMed on a quarterly basis or sooner to comply with ResMed-required regulatory submissions. This listing should include all relevant adverse events that have occurred from the start of the study. In accordance with local legislation, Good Clinical Practice and overall Clinical Trial Safety Management principles, ResMed has the responsibility to evaluate device-related adverse events for reportability. The institution and/or investigator has the responsibility of providing all required information about the device-related adverse event to ResMed as soon as possible. Reporting an AE or SAE to ResMed does not relieve the institution and/or investigator of the responsibility for reporting the events to the FDA, other regulatory authorities, or IRB/EC, as required per relevant local and federal regulations.