Quality Improvement Project vs Human Subject Research: What’s the Difference?
Quality improvement and human subjects research often intersect. Executive IRB Chair Sara Harnish discusses questions to differentiate the two.
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:
Meeting the Challenges of Investigator-Initiated Trials
How does investigator-initiated research differ from other types of clinical research? Advarra IRB Chairperson Robert Romanchuk explains.
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.
Survey Best Practices for Process Improvement
Learn best practices of survey creation to help measure process improvement among stakeholders at an organization.
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.
Do I Need to Comply With the Revised Common Rule?
While many US researchers are aware of the coming Common Rule changes, not everyone is sure whether they will need to comply with the revised regulations.
Reporting to the IRB: Serious Adverse Events (SAEs) in Drug Studies
Learn what the regulations say about IRB reporting requirements for serious adverse events and how some of the undefined “gray areas” can be addressed.