Research Compliance
Differentiating “Public” and “Private” Internet Spaces in IRB Review
The difference between “public” and “private” internet spaces has gained importance with the growing research use of internet and social media platforms as data sources. Read more:
Q&A Part 1 – Evaluating Payment to Participate in Research: Ethical and Regulatory Issues
Dr. Gelinas answers audience questions we weren’t able to address during the webinar.
Study Activation: A Complex Process That Doesn’t Have to Be Painful
If the clinical development time of a new treatment is to ever decrease, reducing the time in study activation is necessary so actual research can be done.
IRB Review of Coronavirus and Other Emerging Infectious Disease Research: Issues to Consider
Advarra IRB experts discuss unique issues that research involving emerging infectious diseases like coronavirus can raise for IRB review. Read more:
Part 11/Annex 11 Independent Audit and Compliance Assessment
Learn how the Advarra Consulting team deployed a proprietary Part 11 / Annex 11 assessment and mock inspection program.
Special Considerations for Pediatric Trials
In this white paper, get to know the key considerations for researchers conducting pediatric clinical trials.
Revised Common Rule Compliance Now in Full Effect—and What That Means
The Revised Common Rule is here after multiple delays, exceptions, and many training sessions. As of January 20, 2020, this regulation is in full effect.
Beyond the Regulations: More Considerations for Emergency Research
Go beyond the regulatory requirements and examine three key actions research organizations must consider before conducting planned emergency research.
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.
Making Sense of the New HUD Guidance
Understand how the new HUD guidance clarifies responsibilites of the IRB and institutions, while widening the access of small communities to HUDs.
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.