Human Subjects Research
FDA/OHRP Harmonization and Your HRPP Operations
This webinar will discuss the human research protection program (HRPP) opportunities and challenges through FDA and OHRP harmonization.
Your Guide to sIRB Mandates
sIRB regulations and policies have been announced and implemented to help address the challenges of conducting clinical trials involving multiple research sites.
Q&A – Ask Advarra Live: The Real-World Impact of COVID-19 on Research
We have addressed the most popular Q&A topics from our recent webinar on the research impact of COVID-19 in this blog post. Read more:
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:
Protocol Feasibility to Promote Trial Efficiency
Many studies do not accrue subjects at the site level, which contributes to a significant amount of waste of staff time and monetary resources. Read more:
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.
How Research Informs the COVID-19 Response
Research doesn’t just inform medical treatment; it informs public health and public policy, and it helps explain human behaviors. Read more:
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:
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.
Most Popular Blogs of 2019
What did the research community enjoy most in 2019? Read Advarra's most popular blogs from industry experts and IRB members here.
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.