Enhancing Research Ethics: Understanding HRPP Staffing and the sIRB Mandate
Understand the significance of HRPP staffing despite an sIRB mandate, and how HRPP staffing maintains ethical research practices.
Beginner’s Guide to Human Research Protection Programs
A robust institutional HRPP plan includes a comprehensive compliance framework and experienced staff focused on protecting research participants.
What is an sIRB and Why Does my Study Need One?
Federal requirements have shifted to require most multisite clinical trials to rely on a single IRB (sIRB) for trial oversight.
Public Perceptions of Clinical Trials: A Comprehensive Survey
In a complex and competitive climate, we sought the understand existing perceptions surrounding clinical research trials.
sIRB 101: An Introduction to Relying on an External IRB
Learn the basics of working with an sIRB and gain insights for successful sIRB relationships with external IRB partners.
Don’t Get Caught Off Guard: Inspection Readiness for Sponsors and CROs
Discover strategies for proactively assessing compliance for an FDA Inspection Readiness visit. Address deficiencies and implement corrective actions.
Device Risk Determinations for IVD Research
Learn the FDA's investigational device exemption requirements for clinical trials involving investigational in vitro diagnostic devices.
Phases of Clinical Research: A Detailed Overview
Gain a comprehensive understanding of the various phases involved in clinical research, their objectives, and outcomes that ensure safe and effective clinical treatment.
4 Unique Challenges of Oncology Trials
Oncology research is unique in many ways, including the challenges researchers face in conducting cutting-edge trials.
Advarra's study startup solutions empower sponsors, CROs, and sites with processes, experts, and integrated technology to accelerate study and site activation.
IBC vs. IRB: What’s the Difference?
Gene therapy research is full of promise, but because of the risks, it’s a highly regulated space requiring oversight by an institutional biosafety committee (IBC).
Data Safety Monitoring Boards Facilitate Ethical Research
Data safety monitoring boards (DSMBs) ensure research participants are protected and results are valid. Learn about DSMB composition, concerns, charter, and challenges.