SUSAR Distribution: A Process Perspective
When it comes to safety report distribution, currently there is an intense focus on drug safety, which creates an increased volume of safety reports, due to regulations. To ensure compliance, these safety reports must be reported within certain time limits and these reports must be distributed to certain stakeholders, including investigators, ethics committee, independent review boards and internal clinical safety monitors. To add to the complexity, these different stakeholders require different kinds of reports and forms.
Once we decide a serious adverse is qualifies as a Suspected Unexpected Serious Adverse Reaction (SUSAR), expedited reporting is required and there’s a “best-practices” process that should be followed.
Watch this 45-minute webinar to learn from Dr. Mathias Poensgen, ArisGlobal’s subject matter expert on the topic to gain insight and better understand how to achieve success.
Topics to cover:
How to avoid pitfalls
Best approach to maximizing efficiency and ensuring compliance
Introduction to agNotify™, ArisGlobal’s automated solution for SUSAR reporting
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