Common use of Protocol Amendments Clause in Contracts

Protocol Amendments. No changes from the final approved (signed) protocol will be initiated without the prior written approval or favorable opinion of a written amendment by the IEC/IRB, except when necessary to eliminate immediate safety concerns to the patients or when the change involves only logistics or administration. Each principal investigator and the sponsor will sign the protocol amendment.

Protocol Amendments. ‌ No changes from the final approved (signed) protocol will be initiated without the prior written approval or favorable opinion of a written amendment by the IEC/IRB, except when necessary to eliminate immediate safety concerns to the patients subjects or when the change involves only logistics or administration. Each The principal investigator and the sponsor will sign the protocol amendment.