Research Compliance
Does Warp Speed Vaccine Development and Testing Compromise Safety?
Fiction often shows warp speed travels not going as planned, but what does warp speed mean for vaccine development in clinical research?
Creating an Integrated Approach to Regulatory Management at Your Institution
Over the past year, clinical research professionals have faced unprecedented challenges related to both the clinical and operational management of their research. Maintaining regulatory compliance and visibility within an increasingly remote environment has been a key focus area for many institutions.
By the Numbers: Our Response to COVID-19
We are honored to support a resilient research community during the COVID-19 pandemic. Explore our resources to find out how we keep research moving forward.
New FDA Certificate of Confidentiality Guidance: What Does it Mean for You?
Certificates of Confidentiality protect participant privacy by preventing disclosed sensitive information during research.
Demonstrating the Impact of the Longboat Portal on Recruitment Success
The Many Faces of “Coercion” and “Undue Influence”
Coercion and undue influence in research can be complicated. Understand what these terms mean and how to appropriately protect against them.
Regulatory Fine Points: Exploring 21 CFR Part 11 Validation
FDA is placing an increased emphasis on compliance with 21 CFR Part 11. Institutions, health systems, IRB offices, private research clinics, and developers—to name a few—need to understand the basics of the regulation and how to comply.
Institutional Responsibilities Under a Federalwide Assurance (FWA)
When institutions are engaged in non-exempt human subjects research supported or conducted by a Common Rule department or agency, they are required to provide written assurance that they will abide the requirements of the Common Rule.
Evaluating Payment to Participate in Research: Ethical and Regulatory Issues
In this webinar, Luke Gelinas, IRB Chairperson at Advarra, proposes a practical framework for evaluating offers of payment and applies it to case studies to yield guidance on challenging ethical and regulatory issues involved in paying research subjects.
Surprise! “Checking the Box” Is Still an Option on the Federalwide Assurance (FWA)
Checking the box is still an option on the FWA. At this time, institutions must carefully consider whether it makes sense to check the box.
Takeaways From the FDA’s VRBPAC Meeting – October 22, 2020
On October 22, 2020, the FDA's VRBPAC met to discuss the development, authorization, and licensure of vaccines to prevent COVID-19.
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