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Brad Russell

Thanks all for your responses.

@Kathy & @Eldin – Both of you state that there is not an expectation that these are included within the eTMF, but that they are inspectable – would then a regulatory body such as MHRA or EMA expect direct access to the system in which these documents are stored? – Furthermore would they expect that this system meets certain requirements (would an environment such as a restricted area SharePoint or Box environment be acceptable?)