Non-English Speaking Research Subjects: What’s in the Regs?
Recently, the clinical research community has been making efforts to include more diverse subject...
FEATURED E-BOOK
Making Good Clinical Practice More Understandable
This eBook dives into GCP’s role in the clinical research ecosystem and how it protects participant rights, safety, and confidentiality.
Evaluating eConsent: Some Considerations from an IRB Perspective
At Advarra we’ve been seeing more and more eConsent studies recently, which is great—eConsent...
Planning Gene Therapy Research? Plan for IBC Review
The completion of the human genome project and advances in genetic engineering have paved...
Component Analysis: Analyzing Benefits and Risks of Individual Interventions to Ensure Appropriate Research Participant Protections
A major element of any IRB review is the examination of potential benefits and...
IRB Review of Adaptive Design Studies
The popularity of adaptive design in clinical research continues to grow. Adaptive design can...
The Six Characteristics of an NCI-Designated Cancer Center
Learn the key characteristics that all NCI-designated cancer centers have in common.
6 Ways Sponsors Can Improve Feasibility Questionnaires
Creating feasibility assessments can be as frustrating for sponsors as answering questionnaires is for...
“Single IRB” vs “Central IRB” – What’s the Difference?
With the rise of single IRB (sIRB) mandates, understanding the nuances between sIRB and...
Beginner’s Guide to an Electronic Data Capture (EDC) System
This post walks you through the basics of an electronic data capture system, providing...
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