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One-year mortality post-severe sepsis and septic shock was significantly reduced after implementation of an early goal-directed therapy protocol for sepsis in a large urban emergency department.
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There are two major fears when it comes to a research organization having a potential compliance breach, and these are unpleasant findings during a regulatory audit and bad publicity.
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Research organizational leaders sometimes forget that it takes more than firm written rules and guidelines to create an ethical and compliant clinical research atmosphere.
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Sometimes the most difficult aspect of managing a clinical research organization or a research office in a university is dealing with the various investigators working together in difficult deadline scenarios.
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As clinical research continues to show the benefit of using patient self-reporting, investigators and clinical trial sites should expect to see this practice expanding and improving.
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Patient self-reporting has been successfully used for purposes of evaluating quality of life, satisfaction with care, and looking at symptom end points in clinical trials, but questions have remained about whether or not patient self reports are useful in collecting adverse event data.
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ResearchMatch, the new Web site that will link potential research volunteers with clinical trial sites, has more than 50 institutions enrolled.
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When research organizations establish quality improvement and auditing processes, the chief aims are to improve consistency and efficiency in identifying and preventing noncompliance. One way to do this is through use of an electronic data collection tool.
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