Interim Staffing: Reinvigorating Your Human Research Protections Program
Interim staffing offers HRPPs specialized expertise, fresh perspectives, and support for accreditation and structural improvements without disrupting daily operations.
Reviews
Striking the Balance: Ethics, Inclusion, and Vulnerability in Research
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
The Value of Continuity: Program-level Data Safety Monitoring Boards
In the realm of pharmaceutical development, ensuring the safety and efficacy of new treatments is paramount. One crucial aspect of
Understanding FDA’s 2024 Draft Guidance on DMCs
The FDA’s 2024 draft guidance emphasizes the critical role of independent DMCs in clinical trials, enhancing oversight, safety, and trial integrity.
Reporting to the IRB: Unanticipated Device Effects in Medical Device Studies
In this blog, we’ll take a look at what the regulations do and do not say about IRB reporting requirements and how Advarra has addressed some of the undefined “gray areas.”
DSMB Best Practices and Behind the Scenes Insights
Ensure your DSMB meets regulatory standards. Learn best practices in administration, member selection, and overcoming challenges in clinical trial oversight.
Navigating sIRB Complexities: An Interactive Session
Got questions about sIRBs? Join experts as they share insights and priorities, plus a Q&A to address common concerns and your live questions.
Reporting to the IRB: Investigator Noncompliance
We often get questions about exactly what events should be reported to the IRB. We understand that “reportable events” can be tricky: some “events” are specifically referenced in the regulations, but lack a definition; some are covered in regulatory guidance documents; and some are “industry standard” that are neither an IRB regulation or IRB best practice/guidance. In this blog, we’ll look at what the regulations do and do not say about IRB reporting requirements and how Advarra has addressed some of the undefined “gray areas.”
Sponsors: Are Your Sites Ready for an FDA Inspection?
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
SAE Reporting and the IRB: Adverse Events in Drug Studies
Assessing and reporting adverse events (AEs) in clinical trials is critical to ensuring the study is as safe as possible
sIRB Review for Multicenter Research: A Guide for Institutions
Prepare for single IRB review with insights on reliance agreements, communication plans, lead site responsibilities, and technology needs.
IRB Review of Changes to Previously Approved Research
During the course of study conduct, most research involving human participants will require some form of planned modification or revision.