In this episode of Tea in STEM, we're joined by Nikki Jundt, a seasoned regulatory specialist, to delve into the complexities of Investigator Site File (ISF) maintenance. Nikki shares her expertise and highlights critical challenges faced by research sites, drawing from her recent experience on a CDISC conference panel alongside FDA auditors and CRO representatives. This episode discusses DOA regulations, Re-consenting issues, SUSAR management and Central document distribution. Tune in to uncover how to navigate the evolving regulatory landscape with confidence!
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