Reporting to the IRB: What NOT to Report
Despite clarification from FDA and OHRP, many of the "potential" unanticipated event reports IRBs receive are either submitted unnecessarily or don't pertain to the aspects of research the IRB oversees.
Reporting to the IRB: Investigator Noncompliance
We often get questions about exactly what events should be reported to the IRB. We understand that “reportable events” can be tricky: some “events” are specifically referenced in the regulations,…
Making Sense of the New HUD Guidance
For almost a decade, the FDA guidance on humanitarian use devices (HUDs) dated July 8, 2010 has been the go-to document for industry, FDA staff, clinicians/users, and IRBs to understand…
Should Social Media Be Part of Your Research Toolbox?
Social media holds tremendous promise in the research sphere but requires sensitivity to pertinent regulatory and ethical considerations. Sponsors and investigators looking to incorporate social media into their research toolbox…
A Tale of Two Sites: The Power of Integrated Research Administration
Site timelines for studies can vary widely across the industry due to differences in internal efficiency. In this blog, James Riddle (Advarra VP of Institutional Services and Strategic Consulting) tells…
Reporting to the IRB: Unanticipated Device Effects (UADEs) in Medical Device Studies
In this blog, we’ll take a look at what the regulations do and do not say about IRB reporting requirements and how Advarra has addressed some of the undefined “gray…
How Centralized IBC Review Can Benefit Gene Therapy Research
Gene therapy research is at the forefront of a coming boom in the clinical setting. Understand the growth, risks, and regulatory requirements here.
Advarra Acquires Forte:
What You Need to Know
On September 5, 2019, Advarra announced its intent to acquire Forte. The combined organization leverages mutual strengths in supporting the research community with client service, regulatory expertise, and technology-enabled efficiencies…
Compensating Clinical Trial Participants: The Basics
Many clinical trial protocols include plans to compensate participants for their contribution to the research. According to FDA’s information sheet...
What Is a Screening Consent?
Informed consent is an ongoing process to ensure the participant has an initial and ongoing understanding of the research and its risks. In this blog, we’ll take a look at…
