THE STUDY. 2.1The Institution shall conduct the Study in accordance with the Protocol, as the same may be changed from time to time thereafter and in accordance with prudent research practises. The Investigator shall, where required by applicable law, submit the Protocol for review and approval to its Human Research Ethics Committee / Institutional Review Board or equivalent body in accordance with applicable law, and to an independent review committee of scientists or other qualified individuals as set forth in the Declaration of Helsinki having similar jurisdiction (any such board, body or committee referred to hereinafter as the “IRB”). Changes to the Protocol may be made (i) in accordance with the procedures outlined in the Protocol or (ii) by agreement of the Investigator, Institution and Sponsor. Changes to the Protocol shall be accompanied by such notification, review and/or approval of the IRB as may be required by applicable and and/or the Protocol.
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