Common Audit Findings IP Accountability

- 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 Investigational Product (IP) accountability. As CRAs we have a lot of responsibility when it comes to IP, which remember, is drug that has not been approved by the FDA. We want to ensure it is secure, controlled, provided to only eligible subjects at the protocol specified doses, and stored appropriately in order to ensure it is stable, safe, and effective for subject use. This is my favorite area, and I could go on and on regarding study drug LOL. Join me, as I share some experiences from my monitoring journey, as well as, tips for successful IP review.

You can listen to Common Audit Findings IP Accountability online on Radio and Podcast. Open the player on this page to stream the available audio.

Common Audit Findings IP Accountability is an episode from Let's Get Clinical, Tips From The CRA Helper by Elizabeth.

This episode is 15:22 long.

This episode was published on Feb 25, 2020.

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