Adverse Events; Data Safety Monitoring Plan and Reports Sample Clauses

Adverse Events; Data Safety Monitoring Plan and Reports. For each Trial, the Institution and Principal Investigator shall notify SPONSOR of any information concerning any device deficiency and any serious or unexpected event, injury, toxicity or sensitivity reaction, and the severity thereof, associated with any Trial or any Trial Device in accordance with the Protocol for each Trial with respect to the reporting of adverse Subject experiences. SPONSOR will comply with any data and safety monitoring plan for the Trial as approved by the IRB. During the term of any relevant SOW SPONSOR agrees to report promptly to Principal Investigator in writing any findings from Trial results obtained as part of the Trial that could affect the safety or medical care of a Subject or a Subject’s willingness to continue participation in the Trial, influence the conduct of the Trial, or alter the IRB's determination of whether or how the Trial should be conducted by Institution and/or Principal Investigator. SPONSOR and Institution shall comply with, and nothing herein shall limit, their respective reporting requirements to regulatory authorities, including, for example, the Food and Drug Administration, the Office for Human Research Protections, and others as required. After the term of this Agreement, SPONSOR will provide such information about the safety and use of the Trial Device as it provides in the normal course of business to respond to a field action, recall, or other action related to the relevant Trial Device (“Post-Trial Reporting”). Such Post-Trial Reporting obligation shall continue for two (2) years following the completion or earlier termination of the Trial. In each case, the applicable Principal Investigator and the Institution and/or the IRB as appropriate, shall be free to communicate these findings to each Subject and SPONSOR will not contact a Subject. No other provision shall be construed to override the provisions of this Section.
Sample 1
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