Common Mistakes & Audits. Summary of audit findings by category. Common Mistakes. Delegating responsibility rather than authority The PI is always responsible for all study activity and for all personnel performance Lesson to be learned….PI
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Lesson to be learned….PI
Pick your sub-investigators and coordinators carefully!
This is the Achilles heel of research and is the most commonly cited in litigation
Especially in sponsored research we have a sponsor that continually monitors study activity- it is a common mistake to notify the sponsor of problems and forget to notify the IRB
Type of Audits
FIRST binder they ask for may be correspondence!
NAI-No Action Indicated
VAI-Voluntary action indicated
OAI-Other action indicated