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Strategic Training: Navigating Organizational Challenges
It seems as if everything now is requiring a training for something. In reality, is it needed? While training is...
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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.
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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...
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Interim Staffing: Reinvigorating Your Human Research Protections Program
Evolving regulations, technological advancements, changing societal norms, and new research methodologies can cause an organization to pause and think, “Does...
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The Value of Continuity: Program-level DSMBs
In the realm of pharmaceutical development, ensuring the safety and efficacy of new treatments is paramount. One crucial aspect of...
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Understanding FDA’s 2024 Draft Guidance on DMCs
Clinical trials are the cornerstone of medical advancements, but ensuring their integrity and safety requires meticulous oversight. Data monitoring committees...
The post Understanding FDA’s 2024 Draft Guidance on DMCs appeared first on Advarra.
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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.”
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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...
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Checklist to Reduce Burden on Sites and Patients
The site-sponsor relationship continues to become more important day by day. With trial complexity increasing, site staff availability stretched thin,...
The post Checklist to Reduce Burden on Sites and Patients appeared first on Advarra.
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Enhancing User Experience, Security, and Compliance with Single Sign-on
Every day, clinical research organizations work to deliver a seamless user experience for their staff, while also providing robust security...
The post Enhancing User Experience, Security, and Compliance with Single Sign-on appeared first on Advarra.