Common use of Protocol Modifications Clause in Contracts

Protocol Modifications. In the event future modifications in the Protocol appear desirable, such changes may be made only with the approval of DSI, which shall have sole overriding discretion in such matters, and the subsequent approval of the Study Site’s EC. If such modifications can be expected to affect the cost for the Study, Study Site will submit a written estimate to DSI for approval. Notwithstanding the foregoing, in the course of performing the Study, if deviation from the Protocol is necessary based on generally accepted standards of clinical research and medical practice relating to the benefit, well- being and safety of patients, the Study Site shall notify DSI and CRO in writing prior to implementing such deviation, or in emergency situations, within twenty-four (24) hours thereafter.

Protocol Modifications. In the event future modifications in the Protocol appear desirable, such changes may be made only with the approval of DSI, which shall have sole overriding discretion in such matters, and the subsequent approval of the Study Site’s EC. If such modifications can be expected to affect the cost for the Study, Study Site will submit a written estimate to DSI for approval. Notwithstanding the foregoing, in the course of performing the Study, if deviation from the Protocol is necessary based on generally accepted standards of clinical research and medical practice relating to the benefit, well- well-being and safety of patients, the Study Site shall notify DSI and CRO in writing prior to implementing such deviation, or in emergency situations, within twenty-four (24) hours thereafter.