Article | August 9, 2021

A Beginner's Guide To IND Safety Reporting Under 21 CFR 312(c)

Source: Advarra

By Aidan Gannon, Director of Client Services

Serious Adverse Event (SAE) Reporting In Clinical Trials

At the core of clinical research, the safety of all stakeholders is paramount. To guide the safe and ethical execution of research, the U.S. Food and Drug Administration (FDA) oversees extensive regulations supported by pharmacovigilance teams. Although necessary, complex safety regulations can not only be difficult to understand but also challenging to implement across your research operations. This blog outlines IND safety reporting required under FDA 21 CFR 312.32(c), challenges faced in adhering to the regulation, and strategies to ensure compliance across your research program.

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