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 Advarr...| Advarra - Advancing Better Research
On September 28, 2022, the Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRM). These notices proposed harmonization with the Health and Human Services (HHS) 2018 Common Rule (also referred to as the revised Common Rule). This blog highlights some of the major proposed changes and how they may impact the clinical research| Advarra - Advancing Better Research
Federal requirements have shifted to require most multisite clinical trials to rely on a single IRB (sIRB) for trial oversight.| Advarra