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Soterius • 10 Min Read

Reference Safety Information in Clinical Trials

The Reference Safety Information (RSI) section of an Investigator’s Brochure (IB) is an important document that can be a subject of audits and regulatory inspections. In this post, I have provided guidance for some common questions regarding the RSI. The Reference Safety Information (RSI) section of an Investigator’s Brochure (IB)…

Apr 06, 2022

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