Common use of Serious Adverse Events Clause in Contracts

Serious Adverse Events. All serious adverse events, regardless of causality, will be reported in writing and according to Study procedures and the Protocol by the Investigator to MedImmune and/or its designated representatives within twenty-four (24) hours after the Investigator or the relevant sub investigator has become aware of the serious adverse event. Serious adverse events will also be reported to the relevant ethics committee as per the Regulations and relevant ethics committee requirements. Institution and Investigator will provide assistance to MedImmune and/or its designated representatives as requested to clarify the facts and circumstances of each reported serious adverse event. CRO shall report any adverse events to the regulatory authorities and will prepare and submit the annual safety report to the appropriate regulatory authorities.

Serious Adverse Events. All serious adverse events, regardless of causality, will be reported in writing and according to Study procedures and the Protocol by the Investigator to MedImmune and/or its designated representatives within twenty-four (24) hours after the Investigator or the relevant sub investigator has become aware of the serious adverse event. Serious adverse events will also be reported to the relevant ethics committee as per the Regulations and relevant ethics committee requirements. Institution and Investigator will provide prompt assistance to MedImmune and/or its designated representatives as requested to clarify the facts and circumstances of each reported serious adverse event. CRO shall report any adverse events to the regulatory authorities and will prepare and submit the annual safety report to the appropriate regulatory authorities.