Common Audit Findings_AE Review and Reporting

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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.

#009 - Learning the common audit findings is so beneficial for a CRA. It can serve as a reminder of what to look for and serves as a helpful tool in order to prevent them. This week, I discuss issues associated with AE review and reporting. As CRAs our two most important obligations are subject safety and data integrity. It is extremely important that we monitor this closely, and ensure that data is reliable as this affects regulatory decision making and approvals. We need to ensure that trial data is of high quality as these are patients’ lives. Join me, as I share some experiences from my monitoring journey, as well as, tips for successful AE review.

18 episodes