Understanding the Impact of the New EU Artificial Intelligence Act on Clinical Research
Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. The European Parliament recently adopted
IRB
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.
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.”
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.”
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.
mRNA Cancer Vaccines and Therapies: An Overview
The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. While