Adverse Device Experience and Other Reporting Clause Samples

Adverse Device Experience and Other Reporting. 6.5.1 As applicable, Institution shall notify the IRB and Company as soon as possible, but in no event later than ten (10) business days after Investigator first learns of the unanticipated adverse device effect as required by 21 CFR 812. 6.5.2 During and for a period of at least two years after the completion of the Study, Company shall promptly report to Institution and Sponsor-Investigator any information that could affect the health or safety of past or current Study Subjects, affect Study subjects willingness to continue participation in the Study or influence the conduct of the Study, including but not limited to the Study results and other information learned about the Study Device. In each case, the Sponsor-Investigator and Institution shall be free to communicate these findings to each Study Subject and the IRB.