Subject Safety. As required by any applicable Law governing human subjects research, Sponsor agrees to promptly notify Principal Investigator of any serious adverse events caused by or associated with the Inves- tigational Materials (as defined in Section 5) of which it becomes aware through Sponsor’s monitoring process or research results that could reasonably be expected to affect the safe- ty or medical care of Subjects, or their willing- ness to continue participation in the Trial; sig- nificantly influence the conduct of the Trial; or alter the Ethics Committee’s approval to con- tinue the Trial.
Subject Safety. PHRI agrees to notify Site promptly upon receipt of Study information that would directly affect the health or safety of Subjects. Site shall without delay inform all Subjects and the IRB, as applicable. PHRI shall not be liable for the failure of Site to immediately inform Subjects or IRB of such new information. Site shall promptly report all safety data and information, including but not limited to any failure to comply with or deviations from the Protocols, to PHRI in accordance with the requirements of the Protocol. 1.9
Subject Safety. As required by any applicable Law governing human subjects research, Xxxxxxx agrees to promptly notify Principal Investigator of any serious adverse events caused by or associated with the Inves- tigational Medicinal Product (as defined in Section 5) of which it becomes aware through Sponsor’s monitoring process or research re- sults that could reasonably be expected to af- fect the safety or medical care of Subjects, or their willingness to continue participation in the Trial; significantly influence the conduct of the Trial; or alter the Ethics Committee’s ap- proval to continue the Trial.
Subject Safety. Either Party may terminate this Agreement immediately if Subject safety is a concern or if regulatory or REB approval is not obtained, not reasonably obtainable, or withdrawn.
