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.”
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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.”
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
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
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.
Optimizing Site Initiation Timelines Through Centralized Processes
A centralized CTMS team streamlines trial initiation by uniting resources, ensuring data accuracy, and reducing bottlenecks for efficient site startup.
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
Implementing eSource: A Guide for Operations and Technology Roles
Implementing eSource can streamline data collection for research sites, but ensuring data integrity, compliance, and accuracy is essential for successful adoption and reliable results.
How Sponsors and Sites Work Together to Improve Protocol Compliance
Sites and sponsors can adopt strategies to reduce quality issues and avoid FDA warning letters by improving collaboration, training, and resource access.
Addressing Industry Challenges: Staff Turnover
Staff turnover in clinical research impacts trial quality and timelines. Addressing this requires focus on workplace culture, career growth, and competitive benefits.
Our OnCore CTMS Vision: Building a Foundation for Success
OnCore’s future vision focuses on cloud-hosted solutions, cross-platform reporting, and SSO, enhancing efficiency and user experience for research sites.
Thinking About the Box: Considerations for Transport of Investigational Products
Ensuring the safe and secure transport of investigational products (IP) is a core part of biosafety. This critical task requires