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IRB Submissions to Advarra: Electronic Platform Routing and Data Migration
Beginning May 1, all new study submissions to Advarra’s IRB will be made through the Advarra Center for IRB Intelligence...
Oversight Challenges with Patient Centered Outcomes Research
In this webinar, Luke Gelinas, PhD, IRB Chair at Advarra, lays out some of the oversight challenges raised by PCOR.
An Introduction to Human Gene Transfer Research and Institutional Biosafety Committees (IBCs)
Daniel Eisenman discusses the basics of research involving genetic engineering and the role played by the IBC in ensuring research is conducted safely and responsibly.
Expanded Access and Right to Try: The Impact of Recent Legislative Changes
This webinar provides an overview of the current state of the FDA’s Expanded Access Program and state and federal “Right to Try” legislative efforts.
Navigating the Expanding Regulations of ClinicalTrials.gov Registration and Results Reporting
Anthony Keyes reviews the federal regulations regarding registration and results reporting of clinical trials.
Preparing for and Responding to an FDA Inspection
Ellen Liedel-Sargent and Robert Romanchuk outline key activities that can help prepare a research site for a positive inspection experience.
The EU General Data Protection Regulation: Implications for Research
Leslie Thornton and Nick Wallace provide an introduction to the GDPR and its potential application to the US-based research community.
Improving Diversity in Clinical Trials: Strategies for Inclusive and Ethical Research
Learn practical strategies on how to improve diversity in clinical trials for historically under-represented groups.
Why Now is the Right Time to Adopt eConsent
A valuable tool for both sites and participants, now is the right time for sites to adopt an eConsent platform.
Beginner’s Guide to eTMF, eISF, and Regulatory Research Documents
Global & FDA regulations dictate how researchers organize & store trial documents. Learn the basics of eTMF & eISF clinical research tools
Data Safety Monitoring Boards Facilitate Ethical Research
Data safety monitoring boards (DSMBs) ensure research participants are protected and results are valid. Learn about DSMB composition, concerns, charter, and challenges.
Advarra Trend Report: Analyzing Sites by Organization Type
Clinical Research Workforce survey finds sites once had similar habits, but everyone is approaching the "next normal" differently.
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