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Common Audit Findings_IP Accountability
Manage episode 260804367 series 2665030
Вміст надано Elizabeth. Весь вміст подкастів, включаючи епізоди, графіку та описи подкастів, завантажується та надається безпосередньо компанією Elizabeth або його партнером по платформі подкастів. Якщо ви вважаєте, що хтось використовує ваш захищений авторським правом твір без вашого дозволу, ви можете виконати процедуру, описану тут https://uk.player.fm/legal.
#010 - 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.
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