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Researchers at Temple University in Philadelphia, PA, have developed a novel approach to assessing the potential social risks to participants in a research study before the study commences.
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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment," which includes coinfection with HIV.
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Large research institutions can help clinical trial (CT) investigators and staff improve their study operations and regulatory compliance by providing clinical research staff services through a centralized office.
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Clinical research (CR) organizations should focus on two key areas when targeting compliance: First7, they should centralize their clinical trial operations or make the decentralized system more consistent; secondly, they should put more resources into CR education and training, experts say.
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Clinical trial (CT) sites need to do system-wide risk assessments of the CT process to see where they need to improve policies, procedures, and operations, says Kelly Willenberg, BSN, MBA, president of Synergism, LLC of Chesnee, SC. Willenberg works with sites to improve research compliance, including billing and program compliance services.
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Study recruitment is an increasingly difficult role that requires relationship-building work among community providers and other skills that clinical trial coordinators might lack.
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Researchers and informatics specialists at The Children's Hospital of Philadelphia (CHOP) of Philadelphia, PA, have found a novel way to connect a research tool to popular telephone or hand-held computer technology, making the grading of adverse events (AEs) more efficient and faster.
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The sponsor and sponsored site have a relationship that is tended during a study by the study coordinator and the study monitor.
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Clinical trials now will have to report a number of safety incidents that previously were not reported, according to a final rule issued by the U.S. Food and Drug Administration (FDA).
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