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
Internal IRB reviews are NOT free, contrary to popular belief. In this blog we outline practical steps for assessing and establishing IRB review cost| Advarra