Consistency In Monitoring

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By Elizabeth. Discovered by Player FM and our community — copyright is owned by the publisher, not Player FM, and audio is streamed directly from their servers. Hit the Subscribe button to track updates in Player FM, or paste the feed URL into other podcast apps.

#016 – Monitors are responsible for ensuring subject safety and data integrity. As a CRA, sometimes I felt like a detective on-site looking for clues in order to verify compliance with the protocol, GCPs, and federal regulations. What happens when these “clues” are inconsistent? In this episode I discuss the importance of consistency in monitoring, and ways to ensure data is reliable. Join me, as I share helpful tips to think about when reviewing source documentation in addition to the Investigator Site File.

18 episodes