Common use of Protocol Amendments Clause in Contracts

Protocol Amendments. ‌ Any amendment to the protocol will be written by the Sponsor. Protocol amendments cannot be implemented without prior written IRB approval except as necessary to eliminate immediate safety hazards to subjects. A protocol amendment intended to eliminate an apparent immediate hazard to subjects may be implemented immediately, provided the IRBs are notified within five working days.

Protocol Amendments. ‌ Any amendment to the protocol will be written by the Sponsor. Protocol amendments cannot be implemented without prior written IRB IRB/IEC approval except as necessary to eliminate immediate safety hazards to subjects. A protocol amendment intended to eliminate an apparent immediate hazard to subjects may be implemented immediately, provided the IRBs are notified within five working days.

Protocol Amendments. ‌ Any amendment to the protocol will be written by the Sponsor. Protocol amendments cannot be implemented without prior written IRB IRB/IEC approval except as necessary to eliminate immediate safety hazards to subjectspatients. A protocol amendment intended to eliminate an apparent immediate hazard to subjects patients may be implemented immediately, provided the IRBs are notified within five working days.