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Ways to Streamline Informed Consent Process in Clinical Trial Startup

Optimizing the informed consent process is critical for accelerating clinical trial startup while maintaining compliance and participant understanding. This article explores key strategies for streamlining informed consent, including leveraging electronic consent (eConsent) solutions, standardizing templates, and improving collaboration between sponsors, sites, and IRBs. By implementing these best practices, research teams can enhance efficiency, reduce delays, and improve the participant experience in clinical trials.

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Are “Virtual Trials” Mainstream Yet?

While some completely virtual trials are taking place, the real trend involves bringing virtual trial…

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Key Biosafety Considerations for Coronavirus Research

The recent outbreak of the novel 2019 coronavirus in Wuhan, Hubei Province, China, has led…

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Revised Common Rule Compliance Now in Full Effect—and What That Means

After multiple delays, exceptions, and oh-so-many training sessions, on January 20, 2020, we reached the…

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Beyond the Regulations: More Considerations for Emergency Research

In this blog post we go beyond the regulatory requirements and examine three other key…

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Most Popular Blogs of 2019

As we near the end of 2019, let's take a look back at the blogs…

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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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Making Sense of the New HUD Guidance

For almost a decade, the FDA guidance on humanitarian use devices (HUDs) dated July 8,…

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Should Social Media Be Part of Your Research Toolbox?

Social media holds tremendous promise in the research sphere but requires sensitivity to pertinent regulatory…

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A Tale of Two Sites: The Power of Integrated Research Administration

Site timelines for studies can vary widely across the industry due to differences in internal…

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Advarra Acquires Forte:<br>What You Need to Know

On September 5, 2019, Advarra announced its intent to acquire Forte. The combined organization leverages…

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Compensating Clinical Trial Participants: The Basics

Participant compensation is often a complicated matter; this blog clarifies some issues by shedding light…

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What Is a Screening Consent?

Informed consent is an ongoing process to ensure the participant has an initial and ongoing…

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