IRB
Conducting Research With CAR T Cells
This white paper is a guide for research professionals looking to conduct CAR T cell studies for the first time, as well as for those seeking to expand their existing portfolio.
Single IRB Review: Tips for Sponsors and CROs Working with Institutional Sites
This eBook provides a toolkit to understand the institutional review board's role when sIRB review is utilized.
Navigating Local Considerations When Developing sIRB Reliance Policies
Explore key local considerations for developing single IRB policies, and learn how to navigate the challenges- including compliance, ethical standards, and institutional requirements.
Impact of sIRB Mandates on Study Teams
Much has been written about the impact of single institutional review board (sIRB) mandates on local IRBs and human research...
Interim Staffing: Reinvigorating Your Human Research Protections Program
Uphold research compliance best practices with an innovative approach to HRPP.
Not if, but When: A Study Manager’s Guide to Adaptability and Incoming Trends
Dive into achieving critical milestones across study startup, conduct, and close out that every project manager should optimize.
Reporting to the IRB: Unanticipated Device Effects in Medical Device Studies
What do the regulations say about unanticipated device effects and IRB reporting? In this blog, Advarra addresses unique requirements for medical device studies.
Reporting to the IRB: Investigator Noncompliance
Find out what the regulations say about reporting noncompliance to the IRB and how IRBs have addressed the undefined gray areas.
Striking the Balance: Ethics, Inclusion, and Vulnerability in Research
Explore the ethical tensions between including under-represented communities and ensuring vulnerable participant populations are appropriately protected.
SAE Reporting and the IRB: Adverse Events in Drug Studies
Explore the basics of SAE reporting to the IRB for drug studies. Learn about reportable events, FDA regulations and guidelines, and how to assess AEs.
sIRB Review for Multicenter Research: A Guide for Institutions
Single IRB (sIRB) review for multicenter research is fast becoming the norm in the US. Initiative such as the NIH sIRB policy and revised Common Rule make it clear that ...
Sponsors: Are Your Sites Ready for an FDA Inspection?
Learn a comprehensive overview to prepare sponsors and sites for an FDA inspection.
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