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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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How Paper and Electronic Source Data Meet ALCOA-C Principles

According to the FDA, data should meet certain fundamental elements of quality (ALCOA), whether they’re…

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Strategies for Successful Site Selection in Clinical Trials

Clinical trial site selection can make or break a trial’s success before it even begins.…

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Keys to Unblocking the Innovation Bottleneck in Research

Is the clinical research industry winning or failing at innovation? It probably depends on who…

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Informed Consent Writing Tip Sheet

Crafting informed consent forms requires balancing regulatory compliance with participant understanding, ensuring consent is both…

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How the IND 30-day Hold Impacts Clinical Trial Activities

The Food and Drug Administration (FDA) is the federal entity in the U.S. charged with…

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Streamline Study Startup with Improved Site Selection & Feasibility
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Streamline Study Startup with Improved Site Selection & Feasibility

Site selection for clinical trials is often one of the biggest headaches for pharmaceutical sponsors…

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Scale Your Training Program: Three Successful Models
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Scale Your Training Program: 3 Successful Models

From live sessions to eLearning, scalable training models ensure clinical research teams stay effective, well-informed,…

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Beginner’s Guide to 21 CFR Part 11 Compliance

Ensuring 21 CFR Part 11 compliance in research software protects data integrity, security, and audit…

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Regulatory, Clinical, and Quality Considerations for Device Research
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Regulatory, Clinical, and Quality Considerations for Device Research

In response to a growing demand for faster, approved, and cost-effective medical devices for chronic…

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Safe Sharps Handling When Dispensing Investigational Products

Institutional biosafety committees (IBCs) frequently receive questions about the proper methodology for preparing a syringe…

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Regulatory and Ethical Considerations for eConsent in Research

IRB oversight, identity verification, and comprehension checks are critical in eConsent, ensuring ethical and legal…

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An Evolving Regulatory Environment for Rare and Orphan Diseases
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An Evolving Regulatory Environment for Rare and Orphan Diseases

Rare diseases affect fewer than 200,000 people each, totaling around 30 million in the U.S.…

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