Stephanie Pyle

Director, Content and Communications, Advarra

Latest Posts by Stephanie Pyle

Impact of sIRB Mandates on Study Teams

As sIRB mandates reshape the clinical trial landscape, study teams must navigate unique challenges while...

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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...

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4 Unique Challenges of Oncology Trials

Oncology trials face unique hurdles in innovation, enrollment, and endpoints, requiring strategic planning to address...

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Does Warp Speed Vaccine Development and Testing Compromise Safety?

A common trope in sci-fi movies involves concerns about potentially smashing into uncharted objects while...

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Impact of COVID-19 Outbreak on Ongoing Research and Protocols Under Advarra IRB Review

Advarra has policies and processes in place to keep IRB operations functioning as normal during...

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IRB Review of Coronavirus and Other Emerging Infectious Disease Research: Issues to Consider

In this blog we discuss unique issues that research involving emerging infectious diseases like coronavirus...

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NWABR Appoints Advarra Executive James Riddle to Board of Directors

The Northwest Association for Biomedical Research (NWABR) has appointed James Riddle, Advarra VP of Institutional...

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Revised Common Rule Single IRB Mandate Now Effective

Compliance with the single IRB mandate for cooperative research, as outlined in the revised Common...

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NIH Decision Tool Updated to Incorporate Revised Common Rule

NIH has updated its human subjects research decision tool to reflect changes brought about by...

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Updated IRB Handbook Now Available

Advarra has updated its IRB Handbook for Investigators, Institutions, Sponsors, and Sponsors’ Representatives to incorporate...

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Reporting to the IRB: What NOT to Report

Despite clarification from FDA and OHRP, many of the "potential" unanticipated event reports IRBs receive...

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NIH Guidelines Revised to Streamline Oversight of Gene Therapy Research

NIH OSP has revised the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid...

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