IRB
Re-air: Not if, but When: A Study Manager’s Guide to Adaptability and Incoming Trends
Dive deeper into achieving critical milestones across study startup, conduct, and close out that every project manager should optimize.
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: 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.
IRB Review of Changes to Previously Approved Research
Make sure you know the IRB review requirements for amendments involving changes to IRB-approved protocols and other study modifications.
mRNA Cancer Vaccines and Therapies: An Overview
Learn about mRNA’s potential impact on cancer research, the technology’s unique challenges, and strategies for researchers developing mRNA-based cancer studies.
Trend Report: DE&I in Clinical Research: Where we are Today
How is the research community addressing recent regulatory actions urging improved diversity and representation in clinical trials?
IRB Services: Canadian Review
Advarra’s Canadian review service combines local, expert oversight with streamlined processes and the most extensive site reach in Canada.
A Phased Approach to QMS
A phased approach to quality management systems (QMS) ensures quality is embedded at every stage, from discovery to post study.
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