MedDRA re-coding of "historical" safety data
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Protocol
Nov 5, 2008, 5:26:21 AM11/5/08
to pharmacovigilance
Anyone from pharma co. can please advise of the practice of re-coding
of "historical" safety data using the latest MedDRA version ? What's
your company policy ? Do you usually re-code submitted data ? Do you
re-code only for data presentation or analysis?
Thanks.
of "historical" safety data using the latest MedDRA version ? What's
your company policy ? Do you usually re-code submitted data ? Do you
re-code only for data presentation or analysis?
Thanks.
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