IRB
What Level of Review Does Your Study Need?
In this infographic, we share useful information for investigators to know which level of IRB review likely applies to their study.
Beyond the Regulations: More Considerations for Emergency Research
Go beyond the regulatory requirements and examine three key actions research organizations must consider before conducting planned emergency research.
Advarra VP of Institutional Services & Strategic Consulting Contributes Virtual Trial Regulatory Perspectives to InSite
Advarra Vice President of Institutional Services & Strategic Consulting James Riddle contributed to InSite, The Global Journal for Clinical Research Sites in the article Site Solutions Summit Reflections: A Regulatory Look into Virtual Trials.
Most Popular Blogs of 2019
What did the research community enjoy most in 2019? Read Advarra's most popular blogs from industry experts and IRB members here.
Reporting to the IRB: What NOT to Report
Reportable events can be tricky: according to the regulations, not every unanticipated event should be submitted to the IRB.
Making Sense of the New HUD Guidance
Understand how the new HUD guidance clarifies responsibilites of the IRB and institutions, while widening the access of small communities to HUDs.
Should Social Media Be Part of Your Research Toolbox?
Social media has emerged as a valuable tool for diverse stakeholders across the research community. Learn about the risks and benefits in this article.
Conducting Planned Emergency Research in the Era of sIRB
Planned emergency research (subject to the 21 CFR 50.24 regulations) is challenging for IRBs to review under any circumstance. Now, in the era of single IRB (sIRB), add in the ...
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.
Bloomberg Law Features Advarra Chief Compliance Officer on New Ethics for Fitbit Data
Advarra Chief Compliance Officer and Institutional Official Michele Russell Einhorn was recently featured in Bloomberg Law on Your Fitbit Data Means New Ethics Conundrums for Clinical Trials.
Compensating Clinical Trial Participants: The Basics
Participant compensation is often a complicated matter. This blog will shed light on what an IRB considers during its review.
What Is a Screening Consent?
Study-specific screening consent is a subtype of informed consent, which ensures a research participant understands of the research and its risks.
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