IRB - Advarra - Page 3

Conducting Research With CAR T Cells

Conducting Research With CAR T Cells Regulatory and Practical Considerations Having proven successful in trials for blood cancers considered resistant

Single IRB Review: Tips for Sponsors and CROs Working with Institutional Sites

Discover strategies for sponsors and CROs to navigate single IRB mandates, from institutional IRB roles to optimizing compliance and efficiency.

Navigating Local Considerations When Developing sIRB Reliance Policies

Implementing an sIRB process requires addressing unique local considerations, from consent requirements to cultural nuances, ensuring a streamlined yet ethical review process.

Impact of sIRB Mandates on Study Teams

As sIRB mandates reshape the clinical trial landscape, study teams must navigate unique challenges while ensuring compliance and participant protection.

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.

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.

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.”

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.”