Common use of Protocol Amendments Clause in Contracts

Protocol Amendments. Only the Sponsor (or an authorized representative) will make modifications to the clinical study protocol, which will be documented in a written amendment that describes all changes that will be implemented. Protocol amendments will be categorized as either substantial or non- substantial. Protocol amendments will be considered substantial when the changes have significant impact on: - The safety of physical or mental integrity of the subjects - The scientific value of the study - The conduct or management of the study - The quality or safety of any investigational medicinal product or control used in the study Protocol amendments will be considered non-substantial when the changes affect only administrative issues with the conduct of the study, i.e., changes in telephone numbers or addresses. The Sponsor (or an authorized representative) will be responsible for notifying the appropriate national regulatory authorities in writing of any amendments to the protocol prior to the changes being implemented except in those cases where the changes are necessary to eliminate an immediate hazard to the clinical study subjects. Substantial amendments will require written approval by the IEC/IRB prior to being implemented by the Investigator at the study site except under those circumstances described previously. Non-substantial amendments will not require approval by the IEC/IRB unless requested by the IEC/IRB.

Protocol Amendments. Only the Sponsor (or an authorized representative) will make modifications to the clinical study protocol, which will be documented in a written amendment that describes all changes that will be implemented. Protocol amendments will be categorized as either substantial or non- substantial. Protocol amendments will be considered substantial when the changes have significant impact on: - The safety of physical or mental integrity of the subjects - The scientific value of the study - The conduct or management of the study - The quality or safety of any investigational medicinal product or control used in the study Protocol amendments will be considered non-substantial when the changes affect only administrative issues with the conduct of the study, i.e., i.e. changes in telephone numbers or addresses. The Sponsor (or an authorized representative) will be responsible for notifying the appropriate national regulatory authorities in writing of any amendments to the protocol prior to the changes being implemented except in those cases where the changes are necessary to eliminate an immediate hazard to the clinical study subjects. Substantial amendments will require written approval by the IEC/IRB prior to being implemented by the Investigator at the study site except under those circumstances described previously. Non-substantial amendments will not require approval by the IEC/IRB unless requested by the IEC/IRB.