[Expert Solution]: Which of the following are notable changes…

Which of the following are notable changes to the Investigator section? Confirmation that all submissions to the IRB/IEC must be made by the sponsor only. Clarification that any health professional conducting trial activities, including routine care, must be included in the delegation log. Addition that the investigator should inform the participant about trial results and treatment received post-trial. The requirement for investigators to provide an up-to-date curriculum vitae was removed.