TMF filing of SAE docs
Question for those with direct experience- how have you seen SAE related TMF filing done? Who does it and at what time point? I’m referring to things like SAE report forms, not study wide SAE listings or more specific documents like susar investigator letters.
I was told that all CRAs file SAE reports in the TMF on an ongoing basis, and that it’s standard regardless of the size of the study/sponsor/CRO. What’s your experience (and what’s your role)? I’m curious if this is considered normal, because I was not aware of this as someone who works in PV.
Posted Jun 8, 2026, 10:18 PM UTC
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