Pharmacovigilance (PV)
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Hi all
Do any other CTUs collect and reconcile original SAE forms? We have a fax-based system, and query SAE information via our usual CRF data query system. We collect “wet-ink” copies of CRFs and queries for CRFs and SAEs, but we do not collect original SAEs from sites.
I can’t find any specific info on this in the coveted Grey Guide and would be interested to hear how other CTUs handle this?
Terry
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