Electronic Data Exchange (ICH E2B Clause Samples

Electronic Data Exchange (ICH E2B. When technically and operationally feasible, electronic data exchange using the ICH E2B Guidance and using MI/M2 Standards shall be implemented by Institution as soon as it is able to transmit and receive safety data by that means. Until such time, the Parties shall exchange between themselves all defined safety data, by facsimile or electronic mail. Notwithstanding anything else in this Schedule to the contrary, as soon as it becomes apparent to either Party that an average of more than […***…] SAEs will be generated from the Study each […***…], Institution immediately shall take all necessary steps to ensure that it can begin transmitting and receiving safety data via ICH E2B Guidance at the earliest opportunity, if it is not already doing so at that time.