Emergency Deviations; Amendments Clause Samples

Emergency Deviations; Amendments. Institution and Investigator shall not change the manner in which the Protocol is carried out unless the change is approved in advance by Sponsor and the responsible IEC, except in the event and to the extent necessary to eliminate apparent immediate hazards to the safety of Trial Subject(s) (defined below), and, in such event, Institution and/or Investigator will notify Sponsor and the responsible IEC as soon as practicable but, in any event, no later than two (2) working days after the change is implemented.