Bacteriophage Therapy: A Promising Solution to Antibiotic Resistance
Antibiotic resistance is an emerging problem. Some have argued bacteria are developing antibiotic resistance faster than we can research, develop,
institutions
The Regulatory Binder Checklist For Clinical Trial Sites
A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents;
The Importance of Hazard Communications in Clinical Trials Involving Genetic Engineering
Recombinant DNA technologies and genetically modified biological agents are being adapted for a wide scope of therapeutic applications, and their
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.
Strategic Training: Navigating Organizational Challenges
Training is crucial for changing employee behavior, but not every issue requires it. Identifying when training is necessary can enhance effectiveness and accountability.
Key Items Auditors Look for When Reviewing an Investigator Site File
Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct can be complicated. This blog outlines the details to look out for preparing your investigator site file (ISF) for an audit.
Planning for Complex Change at Your Organization
The only constant in clinical research is change. Researchers are always innovating, making it a necessity to navigate complex organizational
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.
Understanding FDA’s 2024 Draft Guidance on DMCs
The FDA’s 2024 draft guidance emphasizes the critical role of independent DMCs in clinical trials, enhancing oversight, safety, and trial integrity.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.”
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