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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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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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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment," which includes coinfection with HIV.
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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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Karen Daley, PhD, MPH, RN, FAAN, remembers the stick as if it happened in slow-motion, the details still clear to her 12 years later.
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Two-hundred eleven adipose biopsies were obtained from 59 patients participating in the Western Australia HIV cohort study.
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Investigators analyzing data from 1996 to 2007 of more than 35,000 HIV-infected patients have found that people appear to have higher CD4 counts when entering care now than they did 14 years ago. But they're not high enough.
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Investigators at the Bethesda, MD-based Uniformed Services University of the Health Sciences have found strong evidence that HIV has become more virulent over the past 25 years.
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Even 20-plus years into the North American HIV epidemic among injection drug users (IDUs) it is theoretically possible to eliminate the epidemic, dramatically cutting transmission among this aÿ