Advarra Launches Study Design Solution, Powered by Braid, to Improve Operational Efficiency in Clinical Trials — Read the Press Release

IRB

Reporting to the IRB: Investigator Noncompliance

We often get questions about exactly what events should be reported to the IRB. We understand that “reportable events” can be tricky: some “events” are specifically referenced in the regulations, but lack a definition; some are covered in regulatory guidance documents; and some are “industry standard” that are neither an IRB regulation or IRB best practice/guidance. In this blog, we’ll look at what the regulations do and do not say about IRB reporting requirements and how Advarra has addressed some of the undefined “gray areas.”

A Phased Approach to QMS

A phased approach to quality management systems (QMS) ensures quality is embedded at every stage, from discovery to post study.

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