Reply To: FDA Submission Package

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Sarah McWhirter

Hi Kathie,

I’m not the original poster but found your response in a search.

Could you elaborate or provide references for your first point — that it’s rare to maintain datasets in the eTMF and MHRA actually recommends against it?

I found a powerpoint from Andy Fisher that suggests things like printing data to PDF and moving SAS files shouldn’t be done if the source system permits access and archive etc., but looking for something a little more official if possible!