Phase 1 QC strategy?

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      David Ives

      Good afternoon all!

      Looking to hear what standards others have employed for time based or milestone based QC on Phase 1 trials? For example do you only do a closeout QC, do you do a startup, conduct, and closeout but with a limited scope, etc…

      I have seen everything from multiple milestones to only a close out QC, the challenge is often times Phase 1 studies start and stop in a matter of months. This is a small window to QC (completeness in particular). How do you handle this?

      Thanks in advance!

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