I have Communications from a Regulatory Body directly to a Site. Upon reviewing the TMF Reference Model, I noticed that Regulatory Communications are not stored at the Site Level. Can someone explain to me why this is the case and where Site Level Regulatory Communications should be stored?
Are you saying store Site Level Regulatory Communications at the Trial Level; because the eTMF I am working in does not have Regulatory Communications at the Site Level due to the DIA TMF Reference Model stating that Regulatory Communications are not a Site Level Document.
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