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The Institute of Medicine received funding from the American Recovery and Reinvestment Act of 2009 to recommend a list of top priorities for the initial focus in comparative effectiveness research (CER).
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The Patient Protection Affordable Care Act, which was signed into law in March 23, 2010, contains a Physician Payment Sunshine Provision that requires pharmaceutical and biotech companies to report all gifts and compensation made to physicians, including researchers.
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Research organizations increasingly provide guidance to investigators, assisting them with compliance and regulatory documentation, but typically they leave the Good Clinical Practice (GCP) training to sponsors and others.
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Clinical trial sponsors need to build a business plan for their subject recruitment process, and it should include strategies for building a solution and tracking results, an expert says.
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The new health care reform bill provides another big influx of federal research funding, and research organizations will need to prepare and apply as quickly as they can, experts say.
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The Philadelphia-based University of Pennsylvania's office of human research has developed research compliance tools and templates to assist investigators in adhering to Good Clinical Practice.
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Buying media advertisements to recruit subjects often is the easiest way to make a study's enrollment deadlines, but it is an expensive method if not used carefully.
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Research organizations often have trouble distinguishing between protocol deviations and violations, and the regulations are little help in making these definitions, an expert says.
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If your patient complains of abdominal pain, a heart attack might not be the first thing you think of. However, this diagnosis is certainly one possibility, says Cathy C. Fox, RN, CEN, CPEN, clinical nurse educator for the ED at Sentara Virginia Beach (VA) General Hospital.
