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The U.S. Food and Drug Administration (FDA) in recent years has shifted its focus in ways that are resulting in more warning letters and audits conducted based on risk analysis targeting.
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Research institutions often need a quick and efficient compliance and quality improvement strategy. One strategy that can satisfy those objectives is the corrective action plan (CAP).
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A recent study involving recruitment for a nicotine dependence trial has found that African American populations are open to involvement in clinical research when asked.
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Clinical trial sites sometimes make regulatory audit situations worse by failing to respond with comprehensive corrective action plans, an expert says.
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The fear of rejection due to stigma sometimes stops investigators from approaching minority communities about enrolling in research studies. This is a misconception that needs to be addressed and corrected, clinical research ethical experts say.
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Research institutions lose time and efficiency during the typical billing compliance process. The risk of mistakes that could trigger regulatory problems can be high when a Medicare billing process is poorly organized and checks and balances are weak.
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Hospitals across the country are scrambling to improve patient satisfaction so that they won't be dinged by a provision in the Accountable Care Act that will put a portion of Medicare dollars at risk, based on the Hospital Consumer Assessment of Healthcare Providers and Services (HCAPS) surveys.
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New systems and processes can make a big difference in trimming wait times and changing customer perceptions in the ED. However, administrators in the enviable position of being able to design a brand new ED facility have an opportunity to create patient-friendly environments that also cater to their own characteristics in terms of flow processes and volume.