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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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The current focus in federal health policy on coordinating patients' health care throughout the entire continuum of care has resulted in promotion of Accountable Care Organizations (ACO), Medical Homes, and Integrated Delivery Networks.
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Hospice services substantially improved the provision of care and support for nursing home patients dying of dementia and their families, according to an analysis of survey responses from hundreds of bereaved family members. The research comes as hospice funding has received particular scrutiny in the debate over Medicare spending.
