Regulatory & Compliance Oversight | The NIH recently reclassified BESH studies as non-clinical trials, reducing registration and reporting burdens, while simultaneously aligning its “intervention” definition with the 2018 Common Rule, expanding the scope of clinical trials. These...
Regulatory & Compliance Oversight | Research security doesn’t start in an office—it starts with study teams. This article reframes research security as a set of everyday decisions and introduces five essential questions teams should be able to answer to protect data, participants,...
Regulatory & Compliance Oversight Conflict Resolution in Research: Turning Friction into Collaboration Spotlight Story In research, conflict is inevitable—but it doesn’t have to derail progress. From protocol disputes to scheduling strains, learn how active listening, shared...
Regulatory & Compliance Oversight Clinical Trial Compliance: Preparing for FDA Inspection Readiness Being “inspection ready” isn’t just about preparing when the FDA calls — it’s about embedding compliance into daily clinical trial operations. This article explores practical...
Regulatory & Compliance Oversight Back to the Basics: Reference Guides Every Research Admin Should Know For research administrators, understanding the key reference guides, federal frameworks, and day-to-day responsibilities tied to these areas is non-negotiable. This list of...
Regulatory & Compliance Oversight Subaward Oversight: A Report from the Government Accountability Office On March 26, 2025, the United States Government Accountability Office (GAO) released a report, GAO-25-107315, Recent Guidance Could Enhance Subaward Oversight. In this report...