Serious Breach documentation

[Anne-Mette Varney]

Looking for best practices for Serious Breach documentation. We have just implemented a new taxonomi for our TMF following the TMF reference model. According to TMF RM serious breach documentation is only to be filed in artifact 03.03.01. In our old taxonomi we filed the serious breach documentation in the protocol deviation category for both the sponsor and investigator file. This documentation is internal documents sent to and from our internal serious breach group. Additionally we file an overview on trial level. This we have mapped to artifact 01.01.16 in the TMF RM.
The internal documentation of a potential serious breach, does not really fit in the 03.03.01 ‘Notification of Safety or Trial Information’ and also not in 01.01.16 ‘Risk Management Plan’. Do you have Serious Breach documentation and where do you file this in sponsor and investigator file?

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