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Reporting to the IRB: What NOT to Report
Reportable events can be tricky: according to the regulations, not every unanticipated event should be submitted to the IRB.
Should Social Media Be Part of Your Research Toolbox?
Social media has emerged as a valuable tool for diverse stakeholders across the research community. Learn about the risks and benefits in this article.
Reporting to the IRB: Unanticipated Device Effects in Medical Device Studies
What do the regulations say about unanticipated device effects and IRB reporting? In this blog, Advarra addresses unique requirements for medical device studies.
Compensating Clinical Trial Participants: The Basics
Participant compensation is often a complicated matter. This blog will shed light on what an IRB considers during its review.
What Is a Screening Consent?
Study-specific screening consent is a subtype of informed consent, which ensures a research participant understands of the research and its risks.
The Future of Phase I Oncology Studies
Oncology drugs in phase I trials are usually conducted on patients with cancer due to their inherent risk. Advarra IRB member Ran Goldman expands:
The Challenge of Unproven Regenerative Stem Cell Therapies
Stem cell clinics with unproven treatments are on the rise in the US. Learn how the FDA is working to bring new stem cell therapies under federal oversight.
Six Key GDPR Questions to Review
Questions still remain about GDPR and its applications. Have you considered these six key questions to ask within your organization?
Can Ethics Review Catch Up to the CBD Craze?
CBD, a non-psychoactive cannabinoid, is experiencing a massive surge in popularity, but clinical research lags behind in verifying effective uses.
Quorum/Kinetiq Acquisition & Integration:
What You Need to Know
On March 5, 2019, Advarra announced its acquisition of Quorum Review IRB and Kinetiq, the research and technology consulting division of Quorum.
After the Compliance Date: Revised Common Rule FAQs (Or: Why We Cancelled Our February Webinar)
We have cancelled our webinar “After the Compliance Date: Revised Common Rule FAQs,” which was originally scheduled for February 28.
Informed Consent Changes in the Revised Common Rule
If your research must comply with the revised Common Rule, you’ll need to update the way you write ICFs to meet the new requirements.