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Trial Master File Reference Model Discussion Forum
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Home › Forums › Where do I file…. ? › Study level or site level? › Reply To: Study level or site level?

June 25, 2020 at 12:28 am #3677
Elvin Thalund
Participant

Source data are site responsibility and needs SOPs for source data capture, so if ePRO or other sourcing tools are being used, each site needs to validate the systems used and file that in their iSF.

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