IRB
US Medical Device Regulation 101
Speed the review process by understanding how medical devices are classified & what the IRB must review to approve device research.
FWAs Part 2: Managing a Federalwide Assurance and IRB Registration
Join Advarra’s regulatory experts in another discussion of institutional and IRB responsibilities and dig deeper into the FWA topic.
Ethical Issues in the Design and Review of Decentralized Research
This white paper aims to provide a framework to understand ethical issues and steps to take in deploying a decentralized trial
James Riddle and Barbara Schneider Delve into the Different Players Involved in Reviewing Clinical Research
In this podcast episode, we discuss the different clinical research oversight committees and functions to ensure the safety of participants.
IRB Review of Social Media Recruitment and Retention Programs
Explore how existing regulations can establish best practices in using social media for clinical research participant recruitment.
Thorny Issues in Medical Device Research
Learrn how to navigate thorny issues in medical device research, including which regulatory requirements apply to different types of device studies.
Community Consultation in the Time of COVID-19
COVID-19 complicates traditional models of community consultation. How should sites conducting planned emergency research approach community consultation?
IRB Review of Virtual Trial Technologies
What are some of the key issues IRBs face when reviewing research that includes virtual trial technology? Read more:
The Opioid Crisis in America
Combating the opioid crisis requires urgent, evidence-based approaches that address clinical, research, and education issues. Read more:
Q&A – The New Normal: Considerations for Restarting Research
Experts answer some of the most popular audience questions from the recent webinar The New Normal: Considerations for Restart Research. Read more:
Patient Engagement and the IRB
With increased efforts to engage and include patient and participant communities more closely in research, when does an IRB review become required?
Trial Design in the Time of COVID-19: Complex and Efficient
Complex trial designs can eliminate less-promising investigational treatments quickly to speed development, but they remain under-utilized. Read more:
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