Common Contracts
1 similar Sponsor Agreement contracts
SPONSOR AGREEMENTSponsor Agreement • June 11th, 2019
Ulthera, Inc. (hereinafter “Study Sponsor”) maintains responsibility for the ongoing safety of this clinical trial involving the evaluation of the Ulthera System®. Study Sponsor will promptly notify all investigators, the responsible IRB(s)or Ethics Committee(s) (EC), and the regulatory authorities of any findings from ongoing trial monitoring activities that could adversely affect the safety of subjects, impact the conduct of the clinical study, or alter the IRB’s or EC’s approval to continue the study, specifically within 5 working days of making an Unanticipated Adverse Device Effect (UADE) determination or 15 working days after first receiving notice of the UADE, within 10 days for Serious Adverse Event reports, and at least annually for routine reports. In the event that participant safety could be directly affected by study results after the study has ended, Study Sponsor will notify all investigators of these results to enable investigators to consider informing participants as
